New evidence suggests that a booster vaccination against H5N1 avian influenza given years after initial vaccination with a different strain may prove useful in controlling a potential future pandemic. The study is published in the August 1 issue of The Journal of Infectious Diseases, now available online.
H5N1 continues to pose a major health risk to birds and humans. As of mid-June, more than 60 percent of the more than 380 human cases have been fatal, and hundreds of millions of birds have died or been culled to prevent the spread of the disease. Should the virus evolve making human-to-human transmission more likely, a destructive global influenza pandemic could result.
The cornerstone of planning for such a possible pandemic is the development and distribution of effective vaccines. Several vaccines have been developed, but as the virus continues to mutate into genetically distinct lineages, or clades, the problem arises as to whether vaccines based on an older clade will be effective against newer versions. The new study is the first to report that giving one dose of a newer-clade vaccine to those who were vaccinated previously with older versions is more effective than giving only doses of the newer vaccine to unvaccinated subjects.
The study, conducted by Nega Ali Goji, MD, and colleagues from New York, Maryland, and Alabama, gave a single booster dose of a vaccine based on a clade 1 H5N1 virus circulating in Vietnam in 2004 to subjects who eight years earlier had received two doses of a vaccine based on the original, clade 0 virus that appeared in Hong Kong in 1997. Sixty-four percent had a positive immune response, which compares favorably to the results of a previous study using two doses of the clade 1 Vietnam virus, in which only 43 percent of those vaccinated had a positive immune response.
The results not only support the booster technique, but also show that even though the virus had mutated since the initial vaccination, using it to boost an earlier vaccine is more effective than simply vaccinating subjects with the most current vaccine. These findings are important given the fact that influenza viruses are mutating constantly.
"These results suggest that one strategy for pandemic control could involve prevaccination of some segments of the population prior to the emergence of a pandemic so that effective protection could be achieved with a single dose schedule if and when a pandemic emerges," the authors wrote. "If the finding that priming can result in enhanced responses to single-dose vaccination schedules were confirmed, then pre-pandemic vaccination programs could be considered, especially in populations of first responders, health care workers, or the military. Such populations might then be able to be effectively and rapidly vaccinated with a single dose of a vaccine specific for an emerging pandemic if it were to occur."
In an accompanying editorial, Gregory A. Poland, MD, of the Mayo Clinic College of Medicine, noted that some are already looking to begin such prevaccination primers against H5N1 influenza. For example, Japan is planning to immunize health care workers starting in 2009, and the U.S. Department of Defense is offering a vaccine to those in high risk specialties.
Dr. Poland pointed out that new studies are needed to investigate different types of vaccine administration, deal with vaccinations that prevent death but not infection and illness, search for more broadly cross-protective influenza vaccines, and collect data on the vaccination of those who are not healthy adults. Although, he said, "determining who should receive these vaccines, when, and in what order and under what circumstances deserves widespread debate," he agrees that the findings of the study are novel, as they "suggest that such a prime-boost strategy using vaccines derived from different H5 clades, separated by years, may be worthwhile, immunologically feasible, and safe."
Fast Facts
1) Experts are concerned about a possible pandemic of H5N1 influenza. As of mid-June, 60 percent of the more than 380 human cases have been fatal, and half a billion birds have died or been culled to prevent the spread of the disease. Should the virus evolve making human-to-human transmission more likely, a destructive global influenza pandemic could result.
2) Giving a "booster" vaccine using a recent strain of virus to those previously vaccinated with an older strain was more effective than only vaccinating with the recent strain. Especially relevant is the fact that the primer and booster vaccines were derived from different strains of the virus and still were effective.
Founded in 1904, The Journal of Infectious Diseases is the premier publication in the Western Hemisphere for original research on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune mechanisms. Articles in JID include research results from microbiology, immunology, epidemiology, and related disciplines. JID is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Va., IDSA is a professional society representing more than 8,000 physicians and scientists who specialize in infectious diseases. For more information, visit idsociety/.
Source: Steve Baragona
Infectious Diseases Society of America
суббота, 30 апреля 2011 г.
пятница, 29 апреля 2011 г.
Female Farmer Had H5N1 Bird Flu Infection, China Confirmed
The Ministry of Health in China has confirmed a further case of human infection with the H5N1 avian influenza virus. The case is a 31-year-old female farmer from the north-eastern province of Liaoning. She developed symptoms on 30 October and subsequently underwent extensive hospital care for severe pneumonia and acute respiratory distress. She recovered and was discharged from hospital on 29 November.
Initial tests on this case produced negative results for infection with the H5 virus subtype. Diagnostic confirmation was made following antibody testing using a microneutralization test. Using this test, a positive diagnosis is made when antibody levels in a blood sample taken late in illness are at least four times higher than those found in a sample taken early in illness. Diagnostic confirmation using antibody tests, though reliable, is thus slower than that achieved using direct tests for virus RNA.
Beginning in late October, Chinese authorities have reported several outbreaks of highly pathogenic H5N1 avian influenza in poultry in Liaoning Province. Investigation of this case has linked the woman's infection to direct exposure to diseased poultry. Agricultural authorities have detected the H5N1 virus in samples taken from poultry in the province.
As a precaution, local authorities placed contacts of the woman under medical observation pending definitive laboratory results. No signs of influenza-like illness were detected, and all contacts have now been released from observation.
This is China's fifth laboratory-confirmed case. Of these cases, two were fatal. The cases have been reported from four provinces: Anhui, Hunan, Guangxi, and Liaoning.
who.int
Initial tests on this case produced negative results for infection with the H5 virus subtype. Diagnostic confirmation was made following antibody testing using a microneutralization test. Using this test, a positive diagnosis is made when antibody levels in a blood sample taken late in illness are at least four times higher than those found in a sample taken early in illness. Diagnostic confirmation using antibody tests, though reliable, is thus slower than that achieved using direct tests for virus RNA.
Beginning in late October, Chinese authorities have reported several outbreaks of highly pathogenic H5N1 avian influenza in poultry in Liaoning Province. Investigation of this case has linked the woman's infection to direct exposure to diseased poultry. Agricultural authorities have detected the H5N1 virus in samples taken from poultry in the province.
As a precaution, local authorities placed contacts of the woman under medical observation pending definitive laboratory results. No signs of influenza-like illness were detected, and all contacts have now been released from observation.
This is China's fifth laboratory-confirmed case. Of these cases, two were fatal. The cases have been reported from four provinces: Anhui, Hunan, Guangxi, and Liaoning.
who.int
четверг, 28 апреля 2011 г.
Sanofi Pasteur Begins Shipments Of Influenza Vaccine
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, began shipping influenza vaccine (Fluzone(R), Influenza Virus Vaccine) to the U.S. market for the 2006-2007 season. The shipment represents the first of approximately 50
million doses planned for production this year.
The most consistent and reliable supplier of injectable influenza
vaccine for many years, sanofi pasteur is expected to supply approximately
half of the global influenza vaccines market. This shipment will help
providers start to successfully implement their immunization plans for the
upcoming influenza season.
As in past years, the company will use a split-delivery process so that
all customers will receive at least a partial delivery of their orders by
the end of September. Although this shipping process is more time consuming
and costly for sanofi pasteur, the company has continued the process
because it has been recognized as key to equitably distributing doses and
facilitating the immunization of priority patients across the maximum
number of providers.
Shipments will continue until December as the company produces 50
million doses of influenza vaccine for this season. It is important to
remember that the influenza season lasts from October through April, with
February typically being the period of most intense disease activity.
Therefore, it is still valuable to obtain an influenza vaccination in
December, January and beyond.
To keep pace with the nation's growing and changing immunization needs,
sanofi pasteur has expanded its influenza vaccine production capability. In
July 2005, construction began on a new influenza vaccine production
facility in Swiftwater, Pennsylvania, that will more than double the
company's U.S. capacity. The new plant is expected to come online for the
2008-2009 season.
Influenza immunization is now recommended for healthy children 6
through 59 months of age. Children younger than 9 years of age receiving
influenza vaccine for the first time require two doses, one month apart.
The vaccine is also recommended for household contacts and out-of-home
caregivers of all children younger than 24 months of age.
Other groups that have been identified as being at risk for developing
serious influenza-related complications include the elderly and adults and
children with chronic diseases, such as asthma and diabetes. Influenza
vaccination is also recommended for those 50 to 64 years of age, household
contacts of at-risk individuals, and health-care workers.
All other healthy individuals under 50 years of age and anyone who
wishes to decrease their risk of influenza infection are also encouraged to
seek vaccination.
Fluzone vaccine is the only influenza vaccine licensed for populations
6 months and older. In 2004-2005, sanofi pasteur introduced a new Fluzone
vaccine formulation (trade name: Fluzone(R), Influenza Virus Vaccine, No
Preservative) that does not contain a preservative at any stage in the
manufacturing process. It is the first FDA-licensed injectable influenza
vaccine to be manufactured in this way.
The 2006-2007 influenza vaccine formulation contains the A/New
Caledonia/20/99 (H1N1)-like virus; an A/Wisconsin/67/2005 (H3N2)-like virus
(A/Wisconsin/67/2005 or A/Hiroshima/52/2005strains); and
B/Malaysia/2506/2004- like virus (B/Malaysia/2506/2004 or B/Ohio/1/2005
strains). The three strains for the new influenza vaccine formulation were
confirmed by the Food and Drug Administration (FDA)'s Vaccines and Related
Biological Products Advisory Committee in March 2006 and correspond with
recommendations made by the World Health Organization in February.
Influenza vaccine is reformulated each year to match the strains predicted
to circulate in the coming season.
Safety Information
The most common side effects from influenza vaccine are pain and
swelling at the vaccination site that can last up to two days. Some people
may have mild fever, myalgia (muscle aches), or feel tired for a day or two
after receiving the influenza vaccine. Other systemic reactions can occur.
Injectable influenza vaccine is made from killed strains of the viruses
predicted to be the main causes of influenza in the coming season. Because
the viruses are killed, it is impossible to get influenza from the vaccine.
People who have had previous reactions to the vaccine or people who are
allergic to eggs (the viruses used in the vaccine are grown in eggs), egg
products should not receive influenza vaccine. Persons allergic to
thimerosal should receive a thimerosal-free version of the vaccine. Persons
with acute febrile illness usually should not be vaccinated until their
symptoms have abated. However, minor illnesses with or without fever do not
contraindicate the use of influenza vaccine, particularly among children
with mild upper respiratory tract infection or allergic rhinitis.
For full prescribing information, see the package insert at
sanofi-pasteur.us.
About sanofi-aventis
The sanofi-aventis Group is the world's third-largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular disease, thrombosis, oncology, metabolic
diseases, central nervous system, internal medicine, and vaccines. The
sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold
more than a billion doses of vaccine in 2005, making it possible to protect
more than 500 million people across the globe. The company offers the
broadest range of vaccines, providing protection against 20 bacterial and
viral diseases. For more information, please visit:
sanofi-pasteur.us
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying
assumptions, statements regarding plans, objectives and expectations with
respect to future operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expect," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions.
Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to predict and
generally beyond the control of sanofi-aventis, that could cause actual
results and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include those discussed or identified in the
public filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F
for the year ended December 31, 2005. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Sanofi pasteur
sanofi-pasteur.us
View drug information on Fluzone Preservative-free.
million doses planned for production this year.
The most consistent and reliable supplier of injectable influenza
vaccine for many years, sanofi pasteur is expected to supply approximately
half of the global influenza vaccines market. This shipment will help
providers start to successfully implement their immunization plans for the
upcoming influenza season.
As in past years, the company will use a split-delivery process so that
all customers will receive at least a partial delivery of their orders by
the end of September. Although this shipping process is more time consuming
and costly for sanofi pasteur, the company has continued the process
because it has been recognized as key to equitably distributing doses and
facilitating the immunization of priority patients across the maximum
number of providers.
Shipments will continue until December as the company produces 50
million doses of influenza vaccine for this season. It is important to
remember that the influenza season lasts from October through April, with
February typically being the period of most intense disease activity.
Therefore, it is still valuable to obtain an influenza vaccination in
December, January and beyond.
To keep pace with the nation's growing and changing immunization needs,
sanofi pasteur has expanded its influenza vaccine production capability. In
July 2005, construction began on a new influenza vaccine production
facility in Swiftwater, Pennsylvania, that will more than double the
company's U.S. capacity. The new plant is expected to come online for the
2008-2009 season.
Influenza immunization is now recommended for healthy children 6
through 59 months of age. Children younger than 9 years of age receiving
influenza vaccine for the first time require two doses, one month apart.
The vaccine is also recommended for household contacts and out-of-home
caregivers of all children younger than 24 months of age.
Other groups that have been identified as being at risk for developing
serious influenza-related complications include the elderly and adults and
children with chronic diseases, such as asthma and diabetes. Influenza
vaccination is also recommended for those 50 to 64 years of age, household
contacts of at-risk individuals, and health-care workers.
All other healthy individuals under 50 years of age and anyone who
wishes to decrease their risk of influenza infection are also encouraged to
seek vaccination.
Fluzone vaccine is the only influenza vaccine licensed for populations
6 months and older. In 2004-2005, sanofi pasteur introduced a new Fluzone
vaccine formulation (trade name: Fluzone(R), Influenza Virus Vaccine, No
Preservative) that does not contain a preservative at any stage in the
manufacturing process. It is the first FDA-licensed injectable influenza
vaccine to be manufactured in this way.
The 2006-2007 influenza vaccine formulation contains the A/New
Caledonia/20/99 (H1N1)-like virus; an A/Wisconsin/67/2005 (H3N2)-like virus
(A/Wisconsin/67/2005 or A/Hiroshima/52/2005strains); and
B/Malaysia/2506/2004- like virus (B/Malaysia/2506/2004 or B/Ohio/1/2005
strains). The three strains for the new influenza vaccine formulation were
confirmed by the Food and Drug Administration (FDA)'s Vaccines and Related
Biological Products Advisory Committee in March 2006 and correspond with
recommendations made by the World Health Organization in February.
Influenza vaccine is reformulated each year to match the strains predicted
to circulate in the coming season.
Safety Information
The most common side effects from influenza vaccine are pain and
swelling at the vaccination site that can last up to two days. Some people
may have mild fever, myalgia (muscle aches), or feel tired for a day or two
after receiving the influenza vaccine. Other systemic reactions can occur.
Injectable influenza vaccine is made from killed strains of the viruses
predicted to be the main causes of influenza in the coming season. Because
the viruses are killed, it is impossible to get influenza from the vaccine.
People who have had previous reactions to the vaccine or people who are
allergic to eggs (the viruses used in the vaccine are grown in eggs), egg
products should not receive influenza vaccine. Persons allergic to
thimerosal should receive a thimerosal-free version of the vaccine. Persons
with acute febrile illness usually should not be vaccinated until their
symptoms have abated. However, minor illnesses with or without fever do not
contraindicate the use of influenza vaccine, particularly among children
with mild upper respiratory tract infection or allergic rhinitis.
For full prescribing information, see the package insert at
sanofi-pasteur.us.
About sanofi-aventis
The sanofi-aventis Group is the world's third-largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular disease, thrombosis, oncology, metabolic
diseases, central nervous system, internal medicine, and vaccines. The
sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold
more than a billion doses of vaccine in 2005, making it possible to protect
more than 500 million people across the globe. The company offers the
broadest range of vaccines, providing protection against 20 bacterial and
viral diseases. For more information, please visit:
sanofi-pasteur.us
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying
assumptions, statements regarding plans, objectives and expectations with
respect to future operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expect," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions.
Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to predict and
generally beyond the control of sanofi-aventis, that could cause actual
results and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include those discussed or identified in the
public filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F
for the year ended December 31, 2005. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Sanofi pasteur
sanofi-pasteur.us
View drug information on Fluzone Preservative-free.
среда, 27 апреля 2011 г.
Human Bird Flu Case Confirmed In Djibouti
The Djibouti Ministry of Health has confirmed that a 2-year-old girl is infected with the H5N1 avian influenza virus strain. The girl is from a village in the Arta district. On the 23rd April she started to exhibit bird flu like symptoms. Doctors say her condition is 'stable'. A further three human cases are currently being investigated.
Djobouti is on the north-east coast of Africa, it neighbours Ethiopia, Eritrea and Somalia, and faces Yemen across the sea. It is situated between the western edge of the Gulf of Aden, and the entrance to the Red Sea. Click here to see a map.
This is the first human case of bird flu confirmed in the Horn of Africa. Tests were confirmed by the US Naval Medical Research Unit 3, based in Cairo.
The girl has three siblings. Samples from the siblings have been sent for testing.
Some chickens died of bird flu infection in Djibouti at the beginning of April this year.
Authorities are surveying the area around the girl's home for further human and animal cases. Unfortunately, the country's resources are extremely limited, and without outside help, would become overwhelmed if more cases were found.
Djibouti is also experiencing an outbreak of dengue fever. This makes it hard to separate cases of H5N1 infection and dengue fever.
Djibouti is a country where backyard poultry is common.
The World Health Organization is responding to a Ministry of Health appeal for urgent support.
Written by:
Djobouti is on the north-east coast of Africa, it neighbours Ethiopia, Eritrea and Somalia, and faces Yemen across the sea. It is situated between the western edge of the Gulf of Aden, and the entrance to the Red Sea. Click here to see a map.
This is the first human case of bird flu confirmed in the Horn of Africa. Tests were confirmed by the US Naval Medical Research Unit 3, based in Cairo.
The girl has three siblings. Samples from the siblings have been sent for testing.
Some chickens died of bird flu infection in Djibouti at the beginning of April this year.
Authorities are surveying the area around the girl's home for further human and animal cases. Unfortunately, the country's resources are extremely limited, and without outside help, would become overwhelmed if more cases were found.
Djibouti is also experiencing an outbreak of dengue fever. This makes it hard to separate cases of H5N1 infection and dengue fever.
Djibouti is a country where backyard poultry is common.
The World Health Organization is responding to a Ministry of Health appeal for urgent support.
Written by:
вторник, 26 апреля 2011 г.
Vical Announces Breakthrough For Pandemic Influenza DNA Vaccines With Preliminary Human Data
Vical Incorporated
(Nasdaq: VICL) announced a breakthrough with preliminary clinical
trial data demonstrating that DNA vaccines can safely achieve significant
immune responses against H5N1 pandemic influenza in humans. DNA vaccines
are fundamentally different from conventional vaccines because they do not
contain any part of the virus itself, and may offer compelling advantages
in response to a pandemic outbreak because of significantly reduced
development and manufacturing times.
Specifically, preliminary human safety and immunogenicity data obtained
in a 100-subject Phase 1 trial of the company's Vaxfectin(R)-formulated
H5N1 pandemic influenza DNA vaccines demonstrated for the first time that
DNA vaccines have achieved potentially protective levels of antibody
responses (defined as hemagglutination inhibition, or HI, titers of at
least 40; responses ranged from 40 to 640) in up to 67% of evaluable
subjects in the higher dose cohorts. No significant safety issues were
observed at any of the Vical vaccine doses tested. These results support
further development of Vaxfectin(R)-formulated DNA vaccines, and could
position them as potential alternatives to conventional vaccines.
"The preliminary results from this Phase 1 trial indicate for the first
time that an adjuvanted DNA vaccination against H5N1 influenza is
well-tolerated and can induce impressive antibody responses even against
this relatively weak immunogen," said Robert B. Belshe, M.D., Dianna and J.
Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology,
Saint Louis University School of Medicine, who was the lead external safety
monitor for the study. "Successful development of a safe and effective DNA
vaccine will help address the potential public health threat of pandemic
influenza."
Vijay B. Samant, Vical's President and Chief Executive Officer, said,
"Our preliminary Phase 1 pandemic influenza vaccine results clearly
demonstrate the potential of Vaxfectin(R)-formulated DNA vaccines to
achieve antibody responses in the same range as conventional vaccines. The
ability to manufacture DNA vaccines in weeks rather than the months
required for conventional vaccines may provide a significant advantage when
dealing with an emerging infectious disease such as pandemic influenza.
This trial is also important because it marks the first successful safety
evaluation in humans for our Vaxfectin(R) adjuvant, which has potential
applications with both DNA vaccines and conventional protein-based
vaccines."
The double-blind, placebo-controlled, dose-escalation trial was
conducted in approximately 100 healthy volunteers age 18 to 45 at three
U.S. clinical sites. The trial was designed to assess safety and
immunogenicity following intramuscular vaccination with needle and syringe
or with the Biojector(R) 2000 needle-free injection system in different
cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated
DNA vaccines at various doses. Preliminary results will be presented by
Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., at 12:25
p.m. EDT today, Thursday, July 17, at the IBC Life Sciences Next Generation
Vaccines conference (National Harbor, MD - July 17-18).
In the Phase 1 trial, subjects were injected at Days 0 and 21. Primary
evaluation of antibody responses was by HI antibody titers, the accepted
standard correlate of protection for influenza vaccines. Responders were
those subjects achieving H5 HI titers of at least 40 and achieving at least
a four-fold increase from baseline HI titers. By Day 56, at least 50% and
up to 67% of evaluable subjects were responders in each of the three
cohorts receiving 0.5 mg or 1 mg H5 DNA doses, and there were no responders
in the placebo cohort. More than 90% of the responders had sustained HI
titers through the last measurement to date (Day 84). Neutralizing antibody
production against H5 was demonstrated separately by microneutralization
assays. For comparison, the protein-based pandemic influenza vaccine
currently stockpiled by the U.S. government was approved with HI titers of
40 or more in 44% of subjects by Day 56.
Even at the lowest dose tested (0.033 mg H5 DNA), one of the six
subjects was a responder by Day 56. Some subjects who received the highest
H5 DNA dose were responders at Day 21 after a single vaccine injection.
Preliminary analyses also showed cross-strain immune responses against a
strain of H5N1 from a clade not matching the vaccine. Cross-strain
protection could be important against emerging strains of pandemic
influenza that may not match vaccine stockpiles.
Additional assays are ongoing to further evaluate antibody responses,
breadth and magnitude of T-cell immune responses, cross-strain responses,
and the relative advantages of monovalent vs. trivalent vaccines and needle
vs. needle-free injection.
"These results are important to Vical for three reasons," added Mr.
Samant. "First, they encourage further development of pandemic influenza
DNA vaccines, for which we are currently exploring funding or partnering
options. Second, they support advancement of additional
Vaxfectin(R)-formulated DNA vaccines toward clinical testing. Third, they
provide new incentives for potential commercial partners and collaborators
to explore additional applications for our Vaxfectin(R) adjuvant for DNA
vaccines as well as protein and peptide-based vaccines. We are excited by
these strong preliminary antibody results, and we look forward to
evaluating more detailed immunogenicity data as they become available."
DNA vaccines may offer both technical and economic advantages compared
with conventional vaccine approaches. DNA vaccines encode certain proteins
associated with a target pathogen, rather than using any part of the
pathogen itself, and can prime the immune system as well as induce potent
antibody and T-cell immune responses. DNA vaccines contain no viral
particles, are non-infectious, and can be administered on a repeat basis
without unwanted immune responses. Additionally, DNA vaccines have the
potential to achieve proof of concept more quickly and cost-effectively
than conventional vaccines, and can be manufactured using uniform methods
of fermentation and purification, allowing significantly faster development
and production.
Vical's monovalent vaccine contains a plasmid (a closed loop of DNA)
encoding the hemagglutinin (HA) surface protein from the H5N1 influenza
virus strain, A/Vietnam/1203/04. It is designed primarily to elicit
antibody responses against the H5 protein but could elicit T-cell responses
against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus
separate plasmids encoding consensus sequences of two highly conserved
influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2).
The trivalent vaccine is designed to elicit a combination of T-cell and
antibody responses against all three proteins. Both vaccines are formulated
with the company's Vaxfectin(R) adjuvant, which has demonstrated
effectiveness with a variety of DNA vaccines in multiple animal models as
well as dose-sparing and immune-enhancing ability in animals with a
conventional seasonal influenza vaccine.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements about the
preliminary results of the company's DNA vaccine Phase 1 clinical trial,
the effect of the preliminary Phase 1 clinical trial results on the
company's DNA vaccine and Vaxfectin(R) adjuvant programs and its
collaborative opportunities, and the design and potential benefits of the
company's pandemic influenza vaccine and DNA vaccines generally. Risks and
uncertainties include whether preliminary H5N1 DNA vaccine Phase 1 clinical
trial results will be confirmed upon further analysis or in larger studies;
whether DNA vaccines against H5N1 influenza or any other targets will be
successfully developed and commercialized; whether DNA vaccines will become
alternatives to conventional vaccines; whether DNA vaccines will achieve
immune responses in the same range as conventional vaccines in future
trials; whether infrastructure will be established to manufacture DNA
vaccines at commercial scale in weeks; whether additional data will provide
evidence of neutralizing antibody production, cross-strain immune
responses, or T-cell responses; whether further analysis will reveal any
advantages for the monovalent or trivalent vaccines or for the needle or
needle-free injection methods; whether Vical or others will secure funding
to advance the pandemic influenza DNA vaccine program; whether commercial
partners or collaborators will pursue additional Vaxfectin(R) applications;
whether any product candidates will be shown to be safe and efficacious in
clinical trials; the timing of clinical trials; whether Vical or its
collaborative partners will seek or gain approval to market any product
candidates; the dependence of the company on its collaborative partners;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
(Nasdaq: VICL) announced a breakthrough with preliminary clinical
trial data demonstrating that DNA vaccines can safely achieve significant
immune responses against H5N1 pandemic influenza in humans. DNA vaccines
are fundamentally different from conventional vaccines because they do not
contain any part of the virus itself, and may offer compelling advantages
in response to a pandemic outbreak because of significantly reduced
development and manufacturing times.
Specifically, preliminary human safety and immunogenicity data obtained
in a 100-subject Phase 1 trial of the company's Vaxfectin(R)-formulated
H5N1 pandemic influenza DNA vaccines demonstrated for the first time that
DNA vaccines have achieved potentially protective levels of antibody
responses (defined as hemagglutination inhibition, or HI, titers of at
least 40; responses ranged from 40 to 640) in up to 67% of evaluable
subjects in the higher dose cohorts. No significant safety issues were
observed at any of the Vical vaccine doses tested. These results support
further development of Vaxfectin(R)-formulated DNA vaccines, and could
position them as potential alternatives to conventional vaccines.
"The preliminary results from this Phase 1 trial indicate for the first
time that an adjuvanted DNA vaccination against H5N1 influenza is
well-tolerated and can induce impressive antibody responses even against
this relatively weak immunogen," said Robert B. Belshe, M.D., Dianna and J.
Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology,
Saint Louis University School of Medicine, who was the lead external safety
monitor for the study. "Successful development of a safe and effective DNA
vaccine will help address the potential public health threat of pandemic
influenza."
Vijay B. Samant, Vical's President and Chief Executive Officer, said,
"Our preliminary Phase 1 pandemic influenza vaccine results clearly
demonstrate the potential of Vaxfectin(R)-formulated DNA vaccines to
achieve antibody responses in the same range as conventional vaccines. The
ability to manufacture DNA vaccines in weeks rather than the months
required for conventional vaccines may provide a significant advantage when
dealing with an emerging infectious disease such as pandemic influenza.
This trial is also important because it marks the first successful safety
evaluation in humans for our Vaxfectin(R) adjuvant, which has potential
applications with both DNA vaccines and conventional protein-based
vaccines."
The double-blind, placebo-controlled, dose-escalation trial was
conducted in approximately 100 healthy volunteers age 18 to 45 at three
U.S. clinical sites. The trial was designed to assess safety and
immunogenicity following intramuscular vaccination with needle and syringe
or with the Biojector(R) 2000 needle-free injection system in different
cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated
DNA vaccines at various doses. Preliminary results will be presented by
Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., at 12:25
p.m. EDT today, Thursday, July 17, at the IBC Life Sciences Next Generation
Vaccines conference (National Harbor, MD - July 17-18).
In the Phase 1 trial, subjects were injected at Days 0 and 21. Primary
evaluation of antibody responses was by HI antibody titers, the accepted
standard correlate of protection for influenza vaccines. Responders were
those subjects achieving H5 HI titers of at least 40 and achieving at least
a four-fold increase from baseline HI titers. By Day 56, at least 50% and
up to 67% of evaluable subjects were responders in each of the three
cohorts receiving 0.5 mg or 1 mg H5 DNA doses, and there were no responders
in the placebo cohort. More than 90% of the responders had sustained HI
titers through the last measurement to date (Day 84). Neutralizing antibody
production against H5 was demonstrated separately by microneutralization
assays. For comparison, the protein-based pandemic influenza vaccine
currently stockpiled by the U.S. government was approved with HI titers of
40 or more in 44% of subjects by Day 56.
Even at the lowest dose tested (0.033 mg H5 DNA), one of the six
subjects was a responder by Day 56. Some subjects who received the highest
H5 DNA dose were responders at Day 21 after a single vaccine injection.
Preliminary analyses also showed cross-strain immune responses against a
strain of H5N1 from a clade not matching the vaccine. Cross-strain
protection could be important against emerging strains of pandemic
influenza that may not match vaccine stockpiles.
Additional assays are ongoing to further evaluate antibody responses,
breadth and magnitude of T-cell immune responses, cross-strain responses,
and the relative advantages of monovalent vs. trivalent vaccines and needle
vs. needle-free injection.
"These results are important to Vical for three reasons," added Mr.
Samant. "First, they encourage further development of pandemic influenza
DNA vaccines, for which we are currently exploring funding or partnering
options. Second, they support advancement of additional
Vaxfectin(R)-formulated DNA vaccines toward clinical testing. Third, they
provide new incentives for potential commercial partners and collaborators
to explore additional applications for our Vaxfectin(R) adjuvant for DNA
vaccines as well as protein and peptide-based vaccines. We are excited by
these strong preliminary antibody results, and we look forward to
evaluating more detailed immunogenicity data as they become available."
DNA vaccines may offer both technical and economic advantages compared
with conventional vaccine approaches. DNA vaccines encode certain proteins
associated with a target pathogen, rather than using any part of the
pathogen itself, and can prime the immune system as well as induce potent
antibody and T-cell immune responses. DNA vaccines contain no viral
particles, are non-infectious, and can be administered on a repeat basis
without unwanted immune responses. Additionally, DNA vaccines have the
potential to achieve proof of concept more quickly and cost-effectively
than conventional vaccines, and can be manufactured using uniform methods
of fermentation and purification, allowing significantly faster development
and production.
Vical's monovalent vaccine contains a plasmid (a closed loop of DNA)
encoding the hemagglutinin (HA) surface protein from the H5N1 influenza
virus strain, A/Vietnam/1203/04. It is designed primarily to elicit
antibody responses against the H5 protein but could elicit T-cell responses
against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus
separate plasmids encoding consensus sequences of two highly conserved
influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2).
The trivalent vaccine is designed to elicit a combination of T-cell and
antibody responses against all three proteins. Both vaccines are formulated
with the company's Vaxfectin(R) adjuvant, which has demonstrated
effectiveness with a variety of DNA vaccines in multiple animal models as
well as dose-sparing and immune-enhancing ability in animals with a
conventional seasonal influenza vaccine.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements about the
preliminary results of the company's DNA vaccine Phase 1 clinical trial,
the effect of the preliminary Phase 1 clinical trial results on the
company's DNA vaccine and Vaxfectin(R) adjuvant programs and its
collaborative opportunities, and the design and potential benefits of the
company's pandemic influenza vaccine and DNA vaccines generally. Risks and
uncertainties include whether preliminary H5N1 DNA vaccine Phase 1 clinical
trial results will be confirmed upon further analysis or in larger studies;
whether DNA vaccines against H5N1 influenza or any other targets will be
successfully developed and commercialized; whether DNA vaccines will become
alternatives to conventional vaccines; whether DNA vaccines will achieve
immune responses in the same range as conventional vaccines in future
trials; whether infrastructure will be established to manufacture DNA
vaccines at commercial scale in weeks; whether additional data will provide
evidence of neutralizing antibody production, cross-strain immune
responses, or T-cell responses; whether further analysis will reveal any
advantages for the monovalent or trivalent vaccines or for the needle or
needle-free injection methods; whether Vical or others will secure funding
to advance the pandemic influenza DNA vaccine program; whether commercial
partners or collaborators will pursue additional Vaxfectin(R) applications;
whether any product candidates will be shown to be safe and efficacious in
clinical trials; the timing of clinical trials; whether Vical or its
collaborative partners will seek or gain approval to market any product
candidates; the dependence of the company on its collaborative partners;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
понедельник, 25 апреля 2011 г.
More bird flu cases in Vietnam, H5N1 strain
Vietnamese authorities say that a 21-year-old woman and two other patients from northern Vietnam are infected with bird
flu (H5N1). The H5N1 strain is the more deadly one. The woman is also HIV positive - authorities say she is still very
weak.
There have been 41 cases of bird (avian) flu in Vietnam over the last four months - of which 16 have been deadly.
This present strain is becoming less virulent but spreads faster, apparently.
What is bird flu?
Bird flu or avian influenza is a contagious viral infection that can affect all species of birds.
In intensive poultry rearing systems young fattening turkeys and laying hens are usually the most affected.
Free-living birds may carry influenza viruses without becoming ill due to a natural resistance. Wild waterfowl such as ducks
can have the virus without being ill but can transmit the virus to domestic (not wild) poultry.
What causes it?
The virus which causes bird flu is an Influenzavirus A virus of the family Orthomyxoviridae.
Influenza A viruses infecting poultry can be divided on the basis of their ability to cause disease (pathogenicity).
The very virulent viruses cause highly pathogenic avian influenza (HPAI).
Other AI viruses cause a much milder disease (low pathogenic avianinfluenza, (LPAI). Signs of sickness are much less evident
or even absent and far fewer birds die.
flu (H5N1). The H5N1 strain is the more deadly one. The woman is also HIV positive - authorities say she is still very
weak.
There have been 41 cases of bird (avian) flu in Vietnam over the last four months - of which 16 have been deadly.
This present strain is becoming less virulent but spreads faster, apparently.
What is bird flu?
Bird flu or avian influenza is a contagious viral infection that can affect all species of birds.
In intensive poultry rearing systems young fattening turkeys and laying hens are usually the most affected.
Free-living birds may carry influenza viruses without becoming ill due to a natural resistance. Wild waterfowl such as ducks
can have the virus without being ill but can transmit the virus to domestic (not wild) poultry.
What causes it?
The virus which causes bird flu is an Influenzavirus A virus of the family Orthomyxoviridae.
Influenza A viruses infecting poultry can be divided on the basis of their ability to cause disease (pathogenicity).
The very virulent viruses cause highly pathogenic avian influenza (HPAI).
Other AI viruses cause a much milder disease (low pathogenic avianinfluenza, (LPAI). Signs of sickness are much less evident
or even absent and far fewer birds die.
воскресенье, 24 апреля 2011 г.
Are Some People Immune To Avian Flu?
New results from Richard Webby at St. Jude Children's Research Hospital and colleagues published in the international open-access medical journal PLoS Medicine suggest that the answer might be yes.
The H5N1 avian flu virus is quite different from the seasonal H1N1 and H3N2 flu viruses most humans have been exposed to, which is why many scientists believe that H5N1 could start a new pandemic. (The H and N refer to two virus components, the proteins hemagglutinin and neuraminidase, each of which exists in several varieties identified by a number following the letter.)
Webby and colleagues wondered whether immunity to the human type 1 neuraminidase (huN1) in H1N1 influenza virus strains (and vaccines made to protect against them) could provide protection against avian H5N1 influenza virus, which contains the closely related avian type 1 neuraminidase (avN1). In the new study, they investigated this possibility in mice and in a small group of humans.
The researchers immunized mice with DNA that caused their cells to make the neuraminidase from an H1N1 virus found in human outbreaks. They then examined the immune response of the mice to this huN1 and to avN1 from an avian H5N1 virus isolated from a human patient (A/Vietnam/1203/04). Most of the mice responded to the DNA vaccine by making antibodies that recognized huN1; a few also made antibodies against avN1. (Antibodies are proteins circulating in the body that recognize and stick to some specific part of a foreign agent such as a virus.) All the vaccinated mice survived infection with a man-made flu virus containing huN1, and half also survived infection with low doses of A/Vietnam/1203/04 or of a man-made virus containing avN1.
The researchers then tested blood samples from 38 human volunteers for their ability to inactivate neuraminidase from an H1N1 virus and two H5N1 viruses. Most of the samples were active against the protein from the H1N1 virus; and 8 or 9 also inhibited the protein from both H5N1 viruses.
The results indicate that a vaccine containing huN1 makes mice produce antibodies that partly protect them against avian H5N1 infection. In addition, the human data suggest that a proportion of people have low titer antibodies against H5N1 influenza because of prior exposure to H1N1 viruses or routine influenza vaccination.
As Laura Gillim-Ross and Kanta Subbarao (US National Institute of Allergy and Infectious Diseases) write in an accompanying Perspective article, these results provide a tantalizing suggestion but fall short of demonstrating that there is actual protection in humans against avian flu. Further work is needed to investigate this important question, and Gillim-Ross and Subbarao discuss the challenges and opportunities for such research.
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Both articles will also be part of a collection of articles published in PLoS Medicine and other PLoS journals on various aspects of influenza biology and control. The collection are live at collections.plos/plosmedicine/influenza-2007.php
Citation: Sandbulte MR, Jimenez GS, Boon ACM, Smith LR, Treanor JJ, et al. (2007) Cross-reactive neuraminidase antibodies afford partial protection against H5N1 in mice and are present in unexposed humans. PLoS Med 4(2): e59.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
St. Jude Public Relations
Related PLoS Medicine Perspective article:
The H5N1 avian flu virus is quite different from the seasonal H1N1 and H3N2 flu viruses most humans have been exposed to, which is why many scientists believe that H5N1 could start a new pandemic. (The H and N refer to two virus components, the proteins hemagglutinin and neuraminidase, each of which exists in several varieties identified by a number following the letter.)
Webby and colleagues wondered whether immunity to the human type 1 neuraminidase (huN1) in H1N1 influenza virus strains (and vaccines made to protect against them) could provide protection against avian H5N1 influenza virus, which contains the closely related avian type 1 neuraminidase (avN1). In the new study, they investigated this possibility in mice and in a small group of humans.
The researchers immunized mice with DNA that caused their cells to make the neuraminidase from an H1N1 virus found in human outbreaks. They then examined the immune response of the mice to this huN1 and to avN1 from an avian H5N1 virus isolated from a human patient (A/Vietnam/1203/04). Most of the mice responded to the DNA vaccine by making antibodies that recognized huN1; a few also made antibodies against avN1. (Antibodies are proteins circulating in the body that recognize and stick to some specific part of a foreign agent such as a virus.) All the vaccinated mice survived infection with a man-made flu virus containing huN1, and half also survived infection with low doses of A/Vietnam/1203/04 or of a man-made virus containing avN1.
The researchers then tested blood samples from 38 human volunteers for their ability to inactivate neuraminidase from an H1N1 virus and two H5N1 viruses. Most of the samples were active against the protein from the H1N1 virus; and 8 or 9 also inhibited the protein from both H5N1 viruses.
The results indicate that a vaccine containing huN1 makes mice produce antibodies that partly protect them against avian H5N1 infection. In addition, the human data suggest that a proportion of people have low titer antibodies against H5N1 influenza because of prior exposure to H1N1 viruses or routine influenza vaccination.
As Laura Gillim-Ross and Kanta Subbarao (US National Institute of Allergy and Infectious Diseases) write in an accompanying Perspective article, these results provide a tantalizing suggestion but fall short of demonstrating that there is actual protection in humans against avian flu. Further work is needed to investigate this important question, and Gillim-Ross and Subbarao discuss the challenges and opportunities for such research.
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Both articles will also be part of a collection of articles published in PLoS Medicine and other PLoS journals on various aspects of influenza biology and control. The collection are live at collections.plos/plosmedicine/influenza-2007.php
Citation: Sandbulte MR, Jimenez GS, Boon ACM, Smith LR, Treanor JJ, et al. (2007) Cross-reactive neuraminidase antibodies afford partial protection against H5N1 in mice and are present in unexposed humans. PLoS Med 4(2): e59.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
St. Jude Public Relations
Related PLoS Medicine Perspective article:
1957-58 Flu Pandemic Can Provide Clues To Planning For H1N1
As the U.S. prepares for a resurgence of H1N1 influenza this fall, much can be learned from looking at a previous pandemic that had similar patterns. In an article published today in Biosecurity and Bioterrorism, researchers at the Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) examined historical documents, published material, and newspaper coverage related to the 1957-58 influenza pandemic to compare the progress and severity of that outbreak with the current one. The simple, practical actions taken in 1957 allowed the country to continue functioning with minimal disruption.
Lead author Dr. D. A. Henderson had major responsibility for establishing the CDC influenza surveillance program during the early stages of the 1957 flu; data and analysis of events presented are based on his direct experiences as well as copies of surveillance reports that were published in 1957-58.
"There is need for an understanding in national policy circles of the options for dealing with a pandemic, and time is short if states and local communities are going to be prepared," said Henderson.
During the 1957 pandemic, 25% of the U.S. population became ill, and excess mortality due to pneumonia and influenza occurred. It was a rapidly spreading disease, and it quickly became apparent to U.S. health officials that efforts to stop or slow its spread were futile.
Thus, no efforts were made to quarantine individuals or groups, and a deliberate decision was made not to cancel or postpone large meetings such as conferences, church gatherings, or athletic events. Health officials emphasized providing medical care to those who were sick and keeping community and health services functioning. School absenteeism was high, but schools were not closed unless the number of students or teachers fell low enough to warrant closure.
Special efforts were made to speed the production of vaccine, but the quantities that were produced were too late to substantially affect the impact of the epidemic. The spread of the disease was so rapid that within 3 months it had swept across the country and had largely disappeared.
Although it is impossible to predict the course that H1N1 will take, planning for it can be informed by the experiences of the recent past.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, a quarterly peer-reviewed journal, is published by Mary Ann Liebert, Inc..
The Center for Biosecurity is an independent, nonprofit organization of the University of Pittsburgh Medical Center (UPMC) whose mission is to strengthen national security by reducing the risks posed by biological attacks, epidemics, and other destabilizing events, and to improve the nation's resilience in the face of such events..
Source: Center for Biosecurity of UPMC
Lead author Dr. D. A. Henderson had major responsibility for establishing the CDC influenza surveillance program during the early stages of the 1957 flu; data and analysis of events presented are based on his direct experiences as well as copies of surveillance reports that were published in 1957-58.
"There is need for an understanding in national policy circles of the options for dealing with a pandemic, and time is short if states and local communities are going to be prepared," said Henderson.
During the 1957 pandemic, 25% of the U.S. population became ill, and excess mortality due to pneumonia and influenza occurred. It was a rapidly spreading disease, and it quickly became apparent to U.S. health officials that efforts to stop or slow its spread were futile.
Thus, no efforts were made to quarantine individuals or groups, and a deliberate decision was made not to cancel or postpone large meetings such as conferences, church gatherings, or athletic events. Health officials emphasized providing medical care to those who were sick and keeping community and health services functioning. School absenteeism was high, but schools were not closed unless the number of students or teachers fell low enough to warrant closure.
Special efforts were made to speed the production of vaccine, but the quantities that were produced were too late to substantially affect the impact of the epidemic. The spread of the disease was so rapid that within 3 months it had swept across the country and had largely disappeared.
Although it is impossible to predict the course that H1N1 will take, planning for it can be informed by the experiences of the recent past.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, a quarterly peer-reviewed journal, is published by Mary Ann Liebert, Inc..
The Center for Biosecurity is an independent, nonprofit organization of the University of Pittsburgh Medical Center (UPMC) whose mission is to strengthen national security by reducing the risks posed by biological attacks, epidemics, and other destabilizing events, and to improve the nation's resilience in the face of such events..
Source: Center for Biosecurity of UPMC
суббота, 23 апреля 2011 г.
UK Considering Vaccinating Whole Poultry Stock Against Bird Flu
There are 150 million heads of farmed poultry in the UK - all of which may well be vaccinated soon, according to some sources. As the H5N1 spreads further into Western Europe, the European Union is urging governments to take stiff control measures.
Ornithologists say that a couple of spells of bad winter temperatures in Europe could drive infected wild birds towards the UK.
The UK poultry industry is worth г3 billion ($5.5 billion) a year. There are 20,000 poultry holders in the country - from huge farms to comparatively small holdings.
Vaccinating all poultry stocks is a controversial topic at the moment. Farmers are not convinced it would work. They wonder how complete the government's records are of poultry owners. A full scale vaccination programme would only really work if every single farmed bird were vaccinated.
The UK is separated from mainland Europe by a mere 26 miles of sea - a short trip for most birds. If more cold weather drives birds down from the Baltic sea into Belgium and northern France, they could then hop over the channel and land in the British Isles.
The British Poultry Council says mass vaccinations may not be the best solution. Immunity does not kick in until 4 to 5 weeks after vaccination. Another concern is about human contact with birds. If every head of poultry is vaccinated, this would mean handling every single one. Another problem is matching the right vaccine with the right virus strain.
So far, the UK government has not asked farmers to keep their poultry indoors - as has become the case in most parts of mainland Europe.
Free-range and organic chickens make up a large part of the UK's poultry stocks, when compared to other countries. Over the last ten years consumers have been switching over to free range and organic products in growing numbers.
Vaccinating the chickens would not alter their organic status. Bringing them indoors would definitely alter their free-range status.
In some parts of Europe, especially Italy, sales of chicken for human consumption have plummeted.
Ornithologists say that a couple of spells of bad winter temperatures in Europe could drive infected wild birds towards the UK.
The UK poultry industry is worth г3 billion ($5.5 billion) a year. There are 20,000 poultry holders in the country - from huge farms to comparatively small holdings.
Vaccinating all poultry stocks is a controversial topic at the moment. Farmers are not convinced it would work. They wonder how complete the government's records are of poultry owners. A full scale vaccination programme would only really work if every single farmed bird were vaccinated.
The UK is separated from mainland Europe by a mere 26 miles of sea - a short trip for most birds. If more cold weather drives birds down from the Baltic sea into Belgium and northern France, they could then hop over the channel and land in the British Isles.
The British Poultry Council says mass vaccinations may not be the best solution. Immunity does not kick in until 4 to 5 weeks after vaccination. Another concern is about human contact with birds. If every head of poultry is vaccinated, this would mean handling every single one. Another problem is matching the right vaccine with the right virus strain.
So far, the UK government has not asked farmers to keep their poultry indoors - as has become the case in most parts of mainland Europe.
Free-range and organic chickens make up a large part of the UK's poultry stocks, when compared to other countries. Over the last ten years consumers have been switching over to free range and organic products in growing numbers.
Vaccinating the chickens would not alter their organic status. Bringing them indoors would definitely alter their free-range status.
In some parts of Europe, especially Italy, sales of chicken for human consumption have plummeted.
пятница, 22 апреля 2011 г.
Mute Swans May Have Mild Bird Flu In Michigan
Two Wild Mute Swans in Michigan, USA, have been found to have suspected bird flu. However, scientists say preliminary testing indicates that the virus does not seem to be the virulent H5N1 strain, but rather a milder one that has been detected in the USA before.
The swans were tested on August 8 at the Mouillee state game area, on the coast of Lake Erie, Monroe County, Michigan. Samples were taken by USDA Animal and Plant Health Inspection Service.
Tony Snow, White House spokesman, said scientists believe the strain is of low pathogenicity. Health officials said that this suspected infection does not pose any threat to public health.
According to the US Department of Agriculture, the swans had been sampled as part of the expanded avian influenza surveillance program. The swans showed no signs of sickness - an indication that it is most likely a mild form of bird flu. Genetic analysis conducted at USDA's National Veterinary Services laboratories (NVSL) in Ames, Iowa, suggests it is similar to another milder type of bird flu which has been found in North America.
Scientists say the birds could have been infected with two separate avian influenza viruses, one containing H5 and the other containing N1. Further tests at NVSL will clarify what virus strains they were, as well as their pathogenicity. The results are expected in a couple of weeks.
(Pathogenicity = Capacity for causing disease)
The swans were tested on August 8 at the Mouillee state game area, on the coast of Lake Erie, Monroe County, Michigan. Samples were taken by USDA Animal and Plant Health Inspection Service.
Tony Snow, White House spokesman, said scientists believe the strain is of low pathogenicity. Health officials said that this suspected infection does not pose any threat to public health.
According to the US Department of Agriculture, the swans had been sampled as part of the expanded avian influenza surveillance program. The swans showed no signs of sickness - an indication that it is most likely a mild form of bird flu. Genetic analysis conducted at USDA's National Veterinary Services laboratories (NVSL) in Ames, Iowa, suggests it is similar to another milder type of bird flu which has been found in North America.
Scientists say the birds could have been infected with two separate avian influenza viruses, one containing H5 and the other containing N1. Further tests at NVSL will clarify what virus strains they were, as well as their pathogenicity. The results are expected in a couple of weeks.
(Pathogenicity = Capacity for causing disease)
четверг, 21 апреля 2011 г.
MEDEX Assistance Expands Avian Flu Info Outreach: Comprehensive New Website Is A Free Resource For Corporate And Individual Travelers, Travel Planner
Expanding its longstanding coverage
and counsel regarding the avian flu, MEDEX Assistance today launched a
comprehensive new website that provides the very latest authoritative
updates on the potential pandemic. One of the world's leading providers of
24/7 emergency medical, security and travel assistance, MEDEX Assistance
has been addressing global health issues and serving the needs of corporate
and individual business and leisure travelers for more than 28 years.
Coalesced from the world's leading medical and public health sources,
the new website, medexassist/pandemic, serves as a one-stop
dissemination point for the latest avian flu facts and data. In addition,
MEDEX Assistance provides insights and advice from the company's global
network of travel health professionals. Corporate managers, medical
personnel, risk management professionals, and individual travelers can
access updates regarding the spread of the H5N1 virus and precautions for
minimizing the risk of infection, as well as expert analysis and links to
vital business continuity planning information.
Free public access to this dynamic and continually updated new avian
flu website is a clear and simple click from either the group or individual
portions of the MEDEX Assistance website: medexassist/pandemic or
directly at medexassist/pandemic.
"While we all hope that an Avian Flu pandemic does not become a
reality, we also recognize that 'hoping' is not a viable strategy should it
actually come to pass," stated MEDEX Assistance President and CEO Bruce
Kirby. "Free and open access to information about such a dangerous global
health risk is, in our view, the reasonable and responsible approach."
Noting that the free distribution of avian flu resources and planning
materials has been MEDEX Assistance policy since the company published its
two extensively researched Avian Flu reports nearly a year ago, Kirby
emphasized, "Pandemic planning is something that should be available to
all, not offered exclusively to those corporations willing and able to pay
for it. The goal of our new website is to provide a free and open forum for
a rational and informed decision making, based on facts and not fears."
For additional information about MEDEX Assistance Corporation, contact
Nicole Beach at 410-451-6391 or Richard Altman/REA Communications, Inc. at
914-288-9811. Available Topic Expert(s): For information on the listed expert(s), click appropriate link.
MEDEX Assistance Corporation
and counsel regarding the avian flu, MEDEX Assistance today launched a
comprehensive new website that provides the very latest authoritative
updates on the potential pandemic. One of the world's leading providers of
24/7 emergency medical, security and travel assistance, MEDEX Assistance
has been addressing global health issues and serving the needs of corporate
and individual business and leisure travelers for more than 28 years.
Coalesced from the world's leading medical and public health sources,
the new website, medexassist/pandemic, serves as a one-stop
dissemination point for the latest avian flu facts and data. In addition,
MEDEX Assistance provides insights and advice from the company's global
network of travel health professionals. Corporate managers, medical
personnel, risk management professionals, and individual travelers can
access updates regarding the spread of the H5N1 virus and precautions for
minimizing the risk of infection, as well as expert analysis and links to
vital business continuity planning information.
Free public access to this dynamic and continually updated new avian
flu website is a clear and simple click from either the group or individual
portions of the MEDEX Assistance website: medexassist/pandemic or
directly at medexassist/pandemic.
"While we all hope that an Avian Flu pandemic does not become a
reality, we also recognize that 'hoping' is not a viable strategy should it
actually come to pass," stated MEDEX Assistance President and CEO Bruce
Kirby. "Free and open access to information about such a dangerous global
health risk is, in our view, the reasonable and responsible approach."
Noting that the free distribution of avian flu resources and planning
materials has been MEDEX Assistance policy since the company published its
two extensively researched Avian Flu reports nearly a year ago, Kirby
emphasized, "Pandemic planning is something that should be available to
all, not offered exclusively to those corporations willing and able to pay
for it. The goal of our new website is to provide a free and open forum for
a rational and informed decision making, based on facts and not fears."
For additional information about MEDEX Assistance Corporation, contact
Nicole Beach at 410-451-6391 or Richard Altman/REA Communications, Inc. at
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среда, 20 апреля 2011 г.
Is Bird Flu A Real Threat? How To Tell Fact From Fiction About This And Other Emerging Disease Threats
When it comes to bird flu, Ebola fever, "mad cow" disease, SARS or any number of emerging health threats, it's easy to get caught up in the furor and fear. But at the end of the day, a group of special scientists say what's really needed is common sense.
So is the threat real? "Whether the bird flu virus will spread to North America is unpredictable at this time," says Corrie Brown, Diplomate of the American College of Veterinary Pathologists (ACVP) and a University of Georgia professor of veterinary medicine. "Although the likelihood of this mutation is unlikely, history cautions us to the possibility. The longer the bird flu virus is in circulation, the greater the risk for a pandemic."
For years, veterinary pathologists have been on the front lines, preventing these diseases from spreading from animals to humans, and creating vaccines for those that make that critical leap that turns an emerging threat into a real one.
Early detection and rapid response are the solutions for controlling emerging infectious diseases on a global scale and minimizing the risk of a full-blown human pandemic - a global epidemic affecting a large proportion of the world's population.
When to pay attention to an emerging disease
An "emerging disease" can be either a previously unknown disease agent or a known disease now appearing in a new species or geographic area. When severe acute respiratory syndrome (SARS) was first discovered in China in 2002 and linked to the handling and slaughter of wildlife for human consumption, vet pathologists diagnosed the pathogen and helped curtail its global spread.
Vet pathologists were also the first to diagnose West Nile Virus (WNV), one of several viruses that may be transmitted to people and animals via insect bites. Today they play critical roles on research teams working to alleviate AIDS, SARS, cancer, chronic wasting disease, monkeypox and bioterrorism.
Three-fourths of all emerging human diseases worldwide over the past two decades have originated in animals. Vet pathologists are trained to know what to look for, so they're our front line of defense in the early detection of emerging diseases.
Most emerging diseases are infectious with zoonotic (animal-to-human) potential, occurring at the interface between wildlife, domestic species, and humans. Why are zoonotic diseases more prevalent today? The main reasons are:
(1) Increasing numbers of humans
(2) Expanding globalization of trade
The tripling of international commerce over the past 20 years, combined with runaway population growth, has created a synergy for microorganisms to move freely and quickly from their commonly inhabited domains into unexpected niches, often with lethal results.
Bird flu, or avian influenza, is one example of a recent such threat to human health. Others include severe acute respiratory syndrome (SARS), bovine spongiform encephalopathy (BSE) or "mad cow" disease, and the Ebola virus. Although the risk of animal-to-human transmission is small, given the right set of circumstances, all have the potential to become epidemic - or pandemic.
"The world is only just beginning to become prepared for a human influenza pandemic," says Dr. Brown. "Unfortunately, we are poorly prepared for other emerging infectious diseases, and it's difficult to predict where the next pathogen will come from, or when."
"Our challenge: 'expect the unexpected,' adds Brown, "and always keep things in proper perspective." To learn more, visit acvp.
"There's critical need for a public health surveillance system that's thoroughly integrated with surveillance of wild and domestic animals. Without it, an outbreak of a new infectious disease with high transmissibility and mortality could virtually devastate the human population before sufficient resources could be rallied."
Bird flu facts:
-- The biggest threat is to the poultry industry.
-- Reduced production would impact everyone's pocketbook.
-- The U.S. Department of Agriculture has stringent control measures in place at the borders and is working closely with the poultry industry to boost biosecurity.
-- We still need to be concerned about it infecting wild birds.
-- Mortality of mute swans, ducks, geese, raptors and other wild species associated with the bird flu virus infection in Europe has led to a number of deaths among meat-eating species, including tigers, leopards, domestic cats and humans, who most likely contracted the virus by feeding on carcasses of infected domestic or wild birds.
-- Risk of human infection with the virus in its current form appears to be quite low, as is human-to-human transmission.
-- The virus could become easily transmissible among humans through mutation or reassortment with a human influenza virus.
The American College of Veterinary Pathologists
So is the threat real? "Whether the bird flu virus will spread to North America is unpredictable at this time," says Corrie Brown, Diplomate of the American College of Veterinary Pathologists (ACVP) and a University of Georgia professor of veterinary medicine. "Although the likelihood of this mutation is unlikely, history cautions us to the possibility. The longer the bird flu virus is in circulation, the greater the risk for a pandemic."
For years, veterinary pathologists have been on the front lines, preventing these diseases from spreading from animals to humans, and creating vaccines for those that make that critical leap that turns an emerging threat into a real one.
Early detection and rapid response are the solutions for controlling emerging infectious diseases on a global scale and minimizing the risk of a full-blown human pandemic - a global epidemic affecting a large proportion of the world's population.
When to pay attention to an emerging disease
An "emerging disease" can be either a previously unknown disease agent or a known disease now appearing in a new species or geographic area. When severe acute respiratory syndrome (SARS) was first discovered in China in 2002 and linked to the handling and slaughter of wildlife for human consumption, vet pathologists diagnosed the pathogen and helped curtail its global spread.
Vet pathologists were also the first to diagnose West Nile Virus (WNV), one of several viruses that may be transmitted to people and animals via insect bites. Today they play critical roles on research teams working to alleviate AIDS, SARS, cancer, chronic wasting disease, monkeypox and bioterrorism.
Three-fourths of all emerging human diseases worldwide over the past two decades have originated in animals. Vet pathologists are trained to know what to look for, so they're our front line of defense in the early detection of emerging diseases.
Most emerging diseases are infectious with zoonotic (animal-to-human) potential, occurring at the interface between wildlife, domestic species, and humans. Why are zoonotic diseases more prevalent today? The main reasons are:
(1) Increasing numbers of humans
(2) Expanding globalization of trade
The tripling of international commerce over the past 20 years, combined with runaway population growth, has created a synergy for microorganisms to move freely and quickly from their commonly inhabited domains into unexpected niches, often with lethal results.
Bird flu, or avian influenza, is one example of a recent such threat to human health. Others include severe acute respiratory syndrome (SARS), bovine spongiform encephalopathy (BSE) or "mad cow" disease, and the Ebola virus. Although the risk of animal-to-human transmission is small, given the right set of circumstances, all have the potential to become epidemic - or pandemic.
"The world is only just beginning to become prepared for a human influenza pandemic," says Dr. Brown. "Unfortunately, we are poorly prepared for other emerging infectious diseases, and it's difficult to predict where the next pathogen will come from, or when."
"Our challenge: 'expect the unexpected,' adds Brown, "and always keep things in proper perspective." To learn more, visit acvp.
"There's critical need for a public health surveillance system that's thoroughly integrated with surveillance of wild and domestic animals. Without it, an outbreak of a new infectious disease with high transmissibility and mortality could virtually devastate the human population before sufficient resources could be rallied."
Bird flu facts:
-- The biggest threat is to the poultry industry.
-- Reduced production would impact everyone's pocketbook.
-- The U.S. Department of Agriculture has stringent control measures in place at the borders and is working closely with the poultry industry to boost biosecurity.
-- We still need to be concerned about it infecting wild birds.
-- Mortality of mute swans, ducks, geese, raptors and other wild species associated with the bird flu virus infection in Europe has led to a number of deaths among meat-eating species, including tigers, leopards, domestic cats and humans, who most likely contracted the virus by feeding on carcasses of infected domestic or wild birds.
-- Risk of human infection with the virus in its current form appears to be quite low, as is human-to-human transmission.
-- The virus could become easily transmissible among humans through mutation or reassortment with a human influenza virus.
The American College of Veterinary Pathologists
вторник, 19 апреля 2011 г.
UN Prepares for Avian Flu Pandemic Threat, Dr. David Nabarro to Lead Coordination
Dr. David Nabarro is one of the most senior public health experts around. He has just been appointed by the UN General Secretary to lead the UN's avian influenza response team and prepare for a possible, most agencies say impending, influenza pandemic. He is now the Senior UN system Co-ordinator for Avian and Human Influenza.
As more and more health experts around the world talk about an impending influenza pandemic which 'could kill 150 million people', it is crucial that agencies all over the world take steps to reduce the risk and get prepared, says the World Health Organization.
The WHO has sent detailed guidance to all countries on actions they need to take now. In order to carry out these actions to their fullest advantage good coordination is required across UN agencies, countries, civil society, across sectors within nations and the private sector. The United Nations says all this requires funding.
Dr. Nabarro will have to ensure an effective and coordinated contribution by the UN to control the current avian influenza outbreak (some are calling it an epidemic) that is affecting some countries in Asia. He will also get the UN system to support effective, local, national, regional and global preparations for a potential human influenza pandemic (bird flu that is transmitted from human-to-human).
WHO Director General, Dr. Lee Jong-Wook said, "The WHO has been very clear about the imminent threat of a human influenza pandemic. The world is responding, and is moving quickly to get prepared. However, coordination of these efforts is critical to ensure all stakeholders are giving the best of what they have to offer, and that countries receive the support they urgently require."
Dr. Nabarro is from the UK and has 30 years experience which includes work in community-level and government health programmes, much of it in Asia. He has held several leadership positions within the World Health Organization.
The WHO warns that the current avian flu virus, H5N1, will probably change into a form which spreads easily from human-to-human. Humans do not have a natural immunity to this virus. If the mutated virus spreads rapidly the result could be widespread death in a massive scale as well as social and economic disruption.
Already there have been some cases of healthcare professionals becoming infected by patients who themselves were infected with avian influenza. So, the virus already has a limited capacity to jump from human-to-human. So far, there have been no reported cases of the virus then going on to infect other humans outside the hospitals where the healthcare professionals got infected.
As more and more health experts around the world talk about an impending influenza pandemic which 'could kill 150 million people', it is crucial that agencies all over the world take steps to reduce the risk and get prepared, says the World Health Organization.
The WHO has sent detailed guidance to all countries on actions they need to take now. In order to carry out these actions to their fullest advantage good coordination is required across UN agencies, countries, civil society, across sectors within nations and the private sector. The United Nations says all this requires funding.
Dr. Nabarro will have to ensure an effective and coordinated contribution by the UN to control the current avian influenza outbreak (some are calling it an epidemic) that is affecting some countries in Asia. He will also get the UN system to support effective, local, national, regional and global preparations for a potential human influenza pandemic (bird flu that is transmitted from human-to-human).
WHO Director General, Dr. Lee Jong-Wook said, "The WHO has been very clear about the imminent threat of a human influenza pandemic. The world is responding, and is moving quickly to get prepared. However, coordination of these efforts is critical to ensure all stakeholders are giving the best of what they have to offer, and that countries receive the support they urgently require."
Dr. Nabarro is from the UK and has 30 years experience which includes work in community-level and government health programmes, much of it in Asia. He has held several leadership positions within the World Health Organization.
The WHO warns that the current avian flu virus, H5N1, will probably change into a form which spreads easily from human-to-human. Humans do not have a natural immunity to this virus. If the mutated virus spreads rapidly the result could be widespread death in a massive scale as well as social and economic disruption.
Already there have been some cases of healthcare professionals becoming infected by patients who themselves were infected with avian influenza. So, the virus already has a limited capacity to jump from human-to-human. So far, there have been no reported cases of the virus then going on to infect other humans outside the hospitals where the healthcare professionals got infected.
понедельник, 18 апреля 2011 г.
News From The Journals Of The American Society For Microbiology
"Single-Shot" Vaccines May Protect Against H5N1 Influenza Virus
Two newly developed "single-shot" H5N1 influenza vaccines protected ferrets against lethal infection with the H5N1 influenza virus and may allow for mass vaccination in humans in the event of a pandemic outbreak. The researchers from Australia report their findings in the August 2009 issue of the Journal of Virology.
As the highly infectious H5N1 influenza A virus continues to persist in bird populations and infect humans through poultry, concerns of a pandemic outbreak remain high. Although human-to-human transmission has remained limited, the fatality rate among those reported human cases is greater than 60%. The threat that the virus will mutate and achieve efficient human-to-human spread emphasizes the need for effective preventative therapies.
Vaccination is considered the optimal method for controlling an influenza pandemic. Vaccines must be rapidly available to reach mass populations and they must include the minimal antigen dose (substance that promotes the generation of antibodies) to result in full immunity. The use of adjuvants (substances to improve the immune response) in vaccine development may lower the antigen dose required and ultimately ease the demand on vaccine supply during a pandemic.
Clinical trials on prepandemic vaccines containing adjuvant suggested that two injections were necessary to induce protective immunity. In this study researchers first inoculated ferrets twice with two H5N1 influenza virus adjuvant vaccines (Iscomatrix and AIPO4) and observed for protective efficacy following a lethal challenge with the H5N1 virus. Results showed that ferrets were completely protected against death and disease for at least 15 months. More significantly, a secondary study found that both adjuvant vaccines also protected ferrets from death following only a single inoculation. Specifically, ferrets receiving a single shot of the Iscomatrix adjuvant vaccine displayed fewer signs of infection and remained highly active.
"Our data provide the first indication that in the event of a future influenza pandemic, effective mass vaccination may be achievable with a low-dose 'single shot' vaccine and provide not only increased survival but also significant reduction in disease severity," say the researchers.
(D. Middleton, S. Rockman, M. Pearse, I. Barr, S. Lowther, J. Klippel, D. Ryan, L. Brown. 2009. Evaluation of vaccines for H5N1 influenza virus in ferrets reveals the potential for protective single-shot immunization. Journal of Virology, 83. 15: 7770-7778.)
Infection-Causing Amoeba May be Resistant to Multiple Contact Lens Solutions
A new study suggests that some contact lens solutions do not properly disinfect against Acanthamoeba, a free-living organism in the environment that can cause a painful vision-threatening infection. The researchers from the Centers for Disease Control and Prevention, Public Health Service, and the U.S. Department of Health and Human Services, Atlanta, Georgia, report their findings in the July 2009 issue of the Journal of Clinical Microbiology.
Acanthamoeba are found in a variety of environmental sources including soil, freshwater, brackish water and seawater, as well as hot tubs and Jacuzzis. The species is associated with many different human diseases such as central nervous system infections and Acanthamoeba keratitis (AK), an infection of the cornea that can ultimately lead to blindness. 85% of AK cases in the United States are attributed to contact lens wear, with some specific risk factors being improper contact lens care and contact with nonsterile water during wear.
Insufficient anti-Acanthamoeba activity in Advanced Medical Optics Complete MoisturePlus multipurpose contact lens solution was brought to attention following a recent multistate outbreak of AK. While investigating that outbreak, researchers also compared the effectiveness of 11 other contact lens solutions against cysts of Acanthamoeba castellanii, Acanthamoeba polyphaga, and Acanthamoeba hatchetti, all of which were sample specimens collected during the outbreak. Results indicated that only the two contact lens solutions containing hydrogen peroxide showed any disinfection ability against A. castellanii and A. polyphaga after 6 or 24 hours. No significant disinfection efficacy was noted among the 11 solutions against A. hatchetti.
"The prevention of future cases of AK will require contact lens solutions that are effective against Acanthamoeba species and continued emphasis on proper lens care hygiene," say the researchers. "Educating contact lens wearers about the risk factors for AK, including the improper use of contact lens solutions, is important; but a systematic method for evaluating contact lens solutions will reduce the chance that inefficacious solutions are available."
(S.P. Johnston, R. Sriram, Y. Ovarnstrom, S. Roy, J. Verani, J. Yoder, S. Lorick, J. Roberts, M.J. Beach, G. Visvesvara. 2009. Resistance of Acanthamoeba cysts to disinfection in multiple contact lens solutions. Journal of Clinical Microbiology, 47. 7: 2040-2045.)
New DNA Vaccine Inhibits Deadly Skin Cancer in Mice
A new DNA vaccine inhibited malignant melanoma, a deadly form of skin cancer, in mice by eliciting antibodies that target a gastrin-releasing peptide which is known to play a key role in cancer development. The researchers from China and the U.S. report their findings in the July 2009 issue of the journal Clinical and Vaccine Immunology.
Gastrin-releasing peptide (GRP) is an important human peptide that regulates gastric acid secretion and motor function as well as elicits gastrin release. Previous research has shown that GRP plays a significant role in human cancers through atypical expression of the GRP receptor and GRP binding that activates cellular signaling and results in increased cell production and tumor formation. Anti-GRP antibodies have displayed promising antitumoral activity and DNA vaccines targeting GRP are a hopeful therapeutic approach.
In the study researchers developed a novel anti-GRP DNA vaccine including various immunoadjuvants (substances to improve the immune response) and monitored anti-GRP antibody levels in vaccinated mice. Intramuscular injections induced high levels of specific antibodies against GRP as well as suppressed the growth of melanoma cells. Additionally, researchers intravenously injected cells in the lungs and found that cells were highly diminished indicating that the vaccine may also inhibit cancer from spreading.
"In conclusion, we have demonstrated for the first time that immune responses which are elicited by a novel anti-GRP DNA vaccine suppress the proliferation and growth of melanoma tumors in mice," say the researchers. "The antiangiogenesis and antimetastastic activities of this DNA vaccine suggest a novel approach against various cancers, especially malignant melanoma."
(J. Fang, Y. Lu, K. Ouyang, G. Wu, H. Zhang, Y. Liu, Y. Chen, M. Lin, H. Wang, L. Jin, R. Cao, R.S. Roque, L. Zong, J. Liu, T. Li. 2009. Specific antibodies elicited by a novel DNA vaccine targeting gastrin-releasing peptide inhibit murine melanoma growth in vitro. Clinical and Vaccine Immunology, 16. 7: 1033-1039.)
Two newly developed "single-shot" H5N1 influenza vaccines protected ferrets against lethal infection with the H5N1 influenza virus and may allow for mass vaccination in humans in the event of a pandemic outbreak. The researchers from Australia report their findings in the August 2009 issue of the Journal of Virology.
As the highly infectious H5N1 influenza A virus continues to persist in bird populations and infect humans through poultry, concerns of a pandemic outbreak remain high. Although human-to-human transmission has remained limited, the fatality rate among those reported human cases is greater than 60%. The threat that the virus will mutate and achieve efficient human-to-human spread emphasizes the need for effective preventative therapies.
Vaccination is considered the optimal method for controlling an influenza pandemic. Vaccines must be rapidly available to reach mass populations and they must include the minimal antigen dose (substance that promotes the generation of antibodies) to result in full immunity. The use of adjuvants (substances to improve the immune response) in vaccine development may lower the antigen dose required and ultimately ease the demand on vaccine supply during a pandemic.
Clinical trials on prepandemic vaccines containing adjuvant suggested that two injections were necessary to induce protective immunity. In this study researchers first inoculated ferrets twice with two H5N1 influenza virus adjuvant vaccines (Iscomatrix and AIPO4) and observed for protective efficacy following a lethal challenge with the H5N1 virus. Results showed that ferrets were completely protected against death and disease for at least 15 months. More significantly, a secondary study found that both adjuvant vaccines also protected ferrets from death following only a single inoculation. Specifically, ferrets receiving a single shot of the Iscomatrix adjuvant vaccine displayed fewer signs of infection and remained highly active.
"Our data provide the first indication that in the event of a future influenza pandemic, effective mass vaccination may be achievable with a low-dose 'single shot' vaccine and provide not only increased survival but also significant reduction in disease severity," say the researchers.
(D. Middleton, S. Rockman, M. Pearse, I. Barr, S. Lowther, J. Klippel, D. Ryan, L. Brown. 2009. Evaluation of vaccines for H5N1 influenza virus in ferrets reveals the potential for protective single-shot immunization. Journal of Virology, 83. 15: 7770-7778.)
Infection-Causing Amoeba May be Resistant to Multiple Contact Lens Solutions
A new study suggests that some contact lens solutions do not properly disinfect against Acanthamoeba, a free-living organism in the environment that can cause a painful vision-threatening infection. The researchers from the Centers for Disease Control and Prevention, Public Health Service, and the U.S. Department of Health and Human Services, Atlanta, Georgia, report their findings in the July 2009 issue of the Journal of Clinical Microbiology.
Acanthamoeba are found in a variety of environmental sources including soil, freshwater, brackish water and seawater, as well as hot tubs and Jacuzzis. The species is associated with many different human diseases such as central nervous system infections and Acanthamoeba keratitis (AK), an infection of the cornea that can ultimately lead to blindness. 85% of AK cases in the United States are attributed to contact lens wear, with some specific risk factors being improper contact lens care and contact with nonsterile water during wear.
Insufficient anti-Acanthamoeba activity in Advanced Medical Optics Complete MoisturePlus multipurpose contact lens solution was brought to attention following a recent multistate outbreak of AK. While investigating that outbreak, researchers also compared the effectiveness of 11 other contact lens solutions against cysts of Acanthamoeba castellanii, Acanthamoeba polyphaga, and Acanthamoeba hatchetti, all of which were sample specimens collected during the outbreak. Results indicated that only the two contact lens solutions containing hydrogen peroxide showed any disinfection ability against A. castellanii and A. polyphaga after 6 or 24 hours. No significant disinfection efficacy was noted among the 11 solutions against A. hatchetti.
"The prevention of future cases of AK will require contact lens solutions that are effective against Acanthamoeba species and continued emphasis on proper lens care hygiene," say the researchers. "Educating contact lens wearers about the risk factors for AK, including the improper use of contact lens solutions, is important; but a systematic method for evaluating contact lens solutions will reduce the chance that inefficacious solutions are available."
(S.P. Johnston, R. Sriram, Y. Ovarnstrom, S. Roy, J. Verani, J. Yoder, S. Lorick, J. Roberts, M.J. Beach, G. Visvesvara. 2009. Resistance of Acanthamoeba cysts to disinfection in multiple contact lens solutions. Journal of Clinical Microbiology, 47. 7: 2040-2045.)
New DNA Vaccine Inhibits Deadly Skin Cancer in Mice
A new DNA vaccine inhibited malignant melanoma, a deadly form of skin cancer, in mice by eliciting antibodies that target a gastrin-releasing peptide which is known to play a key role in cancer development. The researchers from China and the U.S. report their findings in the July 2009 issue of the journal Clinical and Vaccine Immunology.
Gastrin-releasing peptide (GRP) is an important human peptide that regulates gastric acid secretion and motor function as well as elicits gastrin release. Previous research has shown that GRP plays a significant role in human cancers through atypical expression of the GRP receptor and GRP binding that activates cellular signaling and results in increased cell production and tumor formation. Anti-GRP antibodies have displayed promising antitumoral activity and DNA vaccines targeting GRP are a hopeful therapeutic approach.
In the study researchers developed a novel anti-GRP DNA vaccine including various immunoadjuvants (substances to improve the immune response) and monitored anti-GRP antibody levels in vaccinated mice. Intramuscular injections induced high levels of specific antibodies against GRP as well as suppressed the growth of melanoma cells. Additionally, researchers intravenously injected cells in the lungs and found that cells were highly diminished indicating that the vaccine may also inhibit cancer from spreading.
"In conclusion, we have demonstrated for the first time that immune responses which are elicited by a novel anti-GRP DNA vaccine suppress the proliferation and growth of melanoma tumors in mice," say the researchers. "The antiangiogenesis and antimetastastic activities of this DNA vaccine suggest a novel approach against various cancers, especially malignant melanoma."
(J. Fang, Y. Lu, K. Ouyang, G. Wu, H. Zhang, Y. Liu, Y. Chen, M. Lin, H. Wang, L. Jin, R. Cao, R.S. Roque, L. Zong, J. Liu, T. Li. 2009. Specific antibodies elicited by a novel DNA vaccine targeting gastrin-releasing peptide inhibit murine melanoma growth in vitro. Clinical and Vaccine Immunology, 16. 7: 1033-1039.)
суббота, 16 апреля 2011 г.
Newly Described "Dragon" Protein Could Be Key To Bird Flu Cure
Scientists and researchers have taken a big step closer to a cure for the most common strain of avian influenza, or "bird flu," the potential pandemic that has claimed more than 200 lives and infected nearly 400 people in 14 countries since it was identified in 2003.
Researchers at the U.S. Department of Energy's (DOE) Argonne National Laboratory, in conjunction with scientists from China and Singapore, have crystallized and characterized the structure of one of the most important protein complexes of the H5N1 virus, the most common strain of bird flu.
All viruses, including H5N1, contain only a small number of proteins that govern all of the viruses' functions. In H5N1, perhaps the most important of these proteins is RNA polymerase, which contains the instructions that allows the virus to copy itself along with all of its genetic material. The Argonne study focused on H5N1's RNA polymerase protein, which contains three subunits: PA, PB1 and PB2.
After performing X-ray crystallography on the protein crystals at Argonne's Structural Biology Center 19ID beamline at the Advanced Photon Source, the researchers saw a surprising resemblance in the protein structure's image. "When we mapped out the PA subunit, it looked very much like the head of a dragon," said Argonne biophysicist Andrzej Joachimiak. "One domain looked like the dragon's brains, and the other looked like its mouth."
During RNA replication the phase during which the virus "reproduces" all three of the subunits of the protein assemble themselves in a particular configuration. In order for this congregation to take place, the researchers determined the end of the PB1 subunit has to insert itself and bind to the "dragon's mouth" part of the PA subunit.
This unexpected relationship between the two subunits could inspire a number of different therapies or vaccines for H5N1 that rely on muzzling the "dragon's" jaws with another molecule or chemical compound that would block the PB1 subunit's access to the PA site, according to Joachimiak. "If we can put a bit in the dragon's mouth, we can slow or even potentially someday stop the spread of avian flu," he said. "Since we are talking about a relatively small protein surface area, finding a way to inhibit RNA replication in H5N1 seems very feasible."
Joachimiak hopes to more precisely identify the types of compounds that could inhibit RNA replication in H5N1 by looking at the atomic-level grooves and pockets within the PA "mouth" region. According to Joachimiak, scientists must gain a more thorough understanding of the geometry of that small region in order to effectively synthesize drugs that could prevent the further spread of bird flu.
Argonne researchers Joachimiak and Rongguang Zhang collaborated with Zihe Rao and Yingfang Liu, both members of the Institute of Biophysics of Chinese Academy of Sciences. Rao is one of the most influential Chinese crystallographers and biophysicists, Joachimiak said. The protein samples were manufactured in China and crystals were shipped to Argonne for data collection and structural analysis.
The results of the study will be reported in an upcoming issue of Nature and can be found online at dx.doi/10.1038/nature07120. The work was funded by the National Natural Science Foundation of China as well as the Chinese Ministry of Science and Technology and the U.S. Department of Energy's Office of Biological and Environmental Research.
About Argonne
The U.S. Department of Energy's Argonne National Laboratory brings the world's brightest scientists and engineers together to find exciting and creative new solutions to pressing national problems in science and technology. The nation's first national laboratory, Argonne conducts leading-edge basic and applied scientific research in virtually every scientific discipline. Argonne researchers work closely with researchers from hundreds of companies, universities, and federal, state and municipal agencies to help them solve their specific problems, advance America's scientific leadership and prepare the nation for a better future. With employees from more than 60 nations, Argonne is managed by UChicago Argonne, LLC for the U.S. Department of Energy's Office of Science.
Argonne National Laboratory
9700 S. Cass Ave., OPA-201
Argonne, IL 60439-4832
United States
anl
Researchers at the U.S. Department of Energy's (DOE) Argonne National Laboratory, in conjunction with scientists from China and Singapore, have crystallized and characterized the structure of one of the most important protein complexes of the H5N1 virus, the most common strain of bird flu.
All viruses, including H5N1, contain only a small number of proteins that govern all of the viruses' functions. In H5N1, perhaps the most important of these proteins is RNA polymerase, which contains the instructions that allows the virus to copy itself along with all of its genetic material. The Argonne study focused on H5N1's RNA polymerase protein, which contains three subunits: PA, PB1 and PB2.
After performing X-ray crystallography on the protein crystals at Argonne's Structural Biology Center 19ID beamline at the Advanced Photon Source, the researchers saw a surprising resemblance in the protein structure's image. "When we mapped out the PA subunit, it looked very much like the head of a dragon," said Argonne biophysicist Andrzej Joachimiak. "One domain looked like the dragon's brains, and the other looked like its mouth."
During RNA replication the phase during which the virus "reproduces" all three of the subunits of the protein assemble themselves in a particular configuration. In order for this congregation to take place, the researchers determined the end of the PB1 subunit has to insert itself and bind to the "dragon's mouth" part of the PA subunit.
This unexpected relationship between the two subunits could inspire a number of different therapies or vaccines for H5N1 that rely on muzzling the "dragon's" jaws with another molecule or chemical compound that would block the PB1 subunit's access to the PA site, according to Joachimiak. "If we can put a bit in the dragon's mouth, we can slow or even potentially someday stop the spread of avian flu," he said. "Since we are talking about a relatively small protein surface area, finding a way to inhibit RNA replication in H5N1 seems very feasible."
Joachimiak hopes to more precisely identify the types of compounds that could inhibit RNA replication in H5N1 by looking at the atomic-level grooves and pockets within the PA "mouth" region. According to Joachimiak, scientists must gain a more thorough understanding of the geometry of that small region in order to effectively synthesize drugs that could prevent the further spread of bird flu.
Argonne researchers Joachimiak and Rongguang Zhang collaborated with Zihe Rao and Yingfang Liu, both members of the Institute of Biophysics of Chinese Academy of Sciences. Rao is one of the most influential Chinese crystallographers and biophysicists, Joachimiak said. The protein samples were manufactured in China and crystals were shipped to Argonne for data collection and structural analysis.
The results of the study will be reported in an upcoming issue of Nature and can be found online at dx.doi/10.1038/nature07120. The work was funded by the National Natural Science Foundation of China as well as the Chinese Ministry of Science and Technology and the U.S. Department of Energy's Office of Biological and Environmental Research.
About Argonne
The U.S. Department of Energy's Argonne National Laboratory brings the world's brightest scientists and engineers together to find exciting and creative new solutions to pressing national problems in science and technology. The nation's first national laboratory, Argonne conducts leading-edge basic and applied scientific research in virtually every scientific discipline. Argonne researchers work closely with researchers from hundreds of companies, universities, and federal, state and municipal agencies to help them solve their specific problems, advance America's scientific leadership and prepare the nation for a better future. With employees from more than 60 nations, Argonne is managed by UChicago Argonne, LLC for the U.S. Department of Energy's Office of Science.
Argonne National Laboratory
9700 S. Cass Ave., OPA-201
Argonne, IL 60439-4832
United States
anl
Swine- And Avian-Origin Influenza Targeted By Immune Molecules
Antibodies are immune molecules that have a key role in protecting against infection with influenza virus. The target of the protective antibodies is the influenza protein HA, which varies so dramatically among influenza viruses that it is used to classify them into subtypes (H1-H16).
It is thought that the antibodies generated by an individual's immune system protect against only a few closely related influenza viruses. However, Antonio Lanzavecchia and colleagues, at the Institute for Research in Biomedicine, Switzerland, have now found that some individuals vaccinated with seasonal influenza vaccine containing H1 and H3 influenza viruses produce antibodies that can target H5 HA, the form of HA used by the deadly H5N1 avian influenza virus.
Although these antibodies protected mice from a recent swine-origin pandemic H1N1 influenza virus and several H5N1 influenza viruses, the authors note that more work needs to be done to determine whether individuals produce these antibodies at high enough levels to provide them with protection from infection by different influenza virus subtypes and how vaccination might promote their high level production.
Title: Heterosubtypic neutralizing antibodies are produced by individuals immunized with a seasonal influenza vaccine
Source:
Karen Honey
Journal of Clinical Investigation
It is thought that the antibodies generated by an individual's immune system protect against only a few closely related influenza viruses. However, Antonio Lanzavecchia and colleagues, at the Institute for Research in Biomedicine, Switzerland, have now found that some individuals vaccinated with seasonal influenza vaccine containing H1 and H3 influenza viruses produce antibodies that can target H5 HA, the form of HA used by the deadly H5N1 avian influenza virus.
Although these antibodies protected mice from a recent swine-origin pandemic H1N1 influenza virus and several H5N1 influenza viruses, the authors note that more work needs to be done to determine whether individuals produce these antibodies at high enough levels to provide them with protection from infection by different influenza virus subtypes and how vaccination might promote their high level production.
Title: Heterosubtypic neutralizing antibodies are produced by individuals immunized with a seasonal influenza vaccine
Source:
Karen Honey
Journal of Clinical Investigation
U.S.-Based Supply Chain For Tamiflu Fully Operational
Roche announced today
that a Tamiflu(R) (oseltamivir phosphate) supply chain is now fully
operational in the U.S., with an annual production capacity of 80 million
treatment courses. The U.S. supply chain is part of Roche's global
production network, which will be capable of producing 400 million
treatment courses of Tamiflu annually by the end of 2006, a more than
ten-fold increase since 2004. Established by Roche at the request of the
U.S. Department of Health & Human Services (HHS), the U.S. supply chain,
which includes Roche sites as well as external contractors, encompasses all
aspects of Tamiflu production, from synthesis of the initial starting
material (shikimic acid) through all major steps of manufacturing to
finished packs.
"The ability to produce Tamiflu from start to finish on U.S. soil is a
significant milestone that will help ensure access to Tamiflu when and
where it is needed," said George Abercrombie, President and CEO,
Hoffmann-La Roche Inc. "This most recent expansion further demonstrates
Roche's long term commitment to serving as a responsible and collaborative
partner with the U.S. government on pandemic preparedness and response."
Tamiflu is approved for the prevention and treatment of influenza in
adults and children one year and older. Tamiflu is designed to be active
against all clinically relevant influenza viruses, including the H5N1
virus, and has been shown to be active against the H5N1 virus in the
laboratory and in animals infected with the H5N1 strain taken from humans.
To date, HHS has ordered 21.3 million courses of Tamiflu for the U.S.
Strategic National Stockpile, which will be delivered in full this year.
The total targeted U.S. stockpile is 81 million antiviral treatment courses
by the end of 2008; HHS plans to purchase 50 million treatment courses and
subsidize by 25 percent the states' purchases of 31 million courses.
The initial starting material for Tamiflu, shikimic acid, is extracted
in one of two ways: from the pods of the star anise or via a fermentation
process. The majority of shikimic acid used in Tamiflu today is derived by
fermentation, reducing reliance on scarce natural sources.
"U.S.-based sources for key steps in the manufacturing process have
been qualified, and have demonstrated the ability to produce at targeted
rates for both the U.S. and globally," explains Jan van Koeveringe, head of
global technical operations at Roche.
Comprehensive Global Production Network
Roche's global manufacturing network includes several Roche sites and
more than 16 external contractors located in ten different countries. Roche
has received and is filling on schedule orders from more than 75 countries
to-date for stockpiling Tamiflu, and its capacity currently outstrips
demand.
Roche has granted sub-licenses to Shanghai Pharmaceutical Group and to
HEC Group for the overall production of oseltamivir for pandemic use in
China, as well as to India's Hetero Drugs to make oseltamivir for India and
developing countries. Roche has also reached an agreement with Aspen for
providing oseltamivir for pandemic use to further help to address the needs
of governments and other not for profit organizations in the African
sub-continent. Additionally, Roche has donated a total of 5.1 million
Tamiflu treatment courses to the World Health Organization (WHO) for use as
rapid stockpiles and regional stockpiles to respond to bird flu outbreaks.
About Tamiflu
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City,
CA, is a systemic treatment for the most common strains of influenza (types
A and B). Tamiflu is indicated for the treatment of uncomplicated acute
influenza caused by virus types A and B in patients one year and older who
have been symptomatic for no more than two days. Tamiflu is also indicated
for the prophylaxis of influenza in patients one year and older.
In treatment studies in adult patients, the most frequently reported
adverse events (incidence >1%) were nausea and vomiting. Other events
reported numerically more frequently in patients taking Tamiflu compared
with placebo were bronchitis, insomnia and vertigo. In treatment studies in
patients one to 12 years old, the most frequently reported adverse event
(incidence >1%) was vomiting. Other events reported more frequently in
patients taking Tamiflu compared with placebo included abdominal pain,
epistaxis, ear disorder and conjunctivitis.
In prophylaxis studies in adult patients, adverse events were similar
to those seen in the treatment studies. Events reported more frequently in
patients taking Tamiflu compared with placebo (incidence >1%) were nausea,
vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a
household prophylaxis trial that included patients one to 12 years old,
adverse events were consistent with those observed in pediatric treatment
studies, with GI events being the most frequently observed.
Treatment efficacy in subjects with chronic cardiac and/or respiratory
disease has not been established. No difference in the incidence of
complications was observed between the treatment and placebo groups in this
population. Safety and efficacy of repeated treatment or prophylaxis
courses have not been studied.
In post-marketing experience, rare cases of anaphylaxis and serious
skin reactions, including toxic epidermal necrolysis, Stevens-Johnson
syndrome and erythema multiforme, have been reported with Tamiflu.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80
countries worldwide.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
rocheusa or roche.us.
Roche
rocheusa
roche.us
View drug information on Tamiflu capsule.
that a Tamiflu(R) (oseltamivir phosphate) supply chain is now fully
operational in the U.S., with an annual production capacity of 80 million
treatment courses. The U.S. supply chain is part of Roche's global
production network, which will be capable of producing 400 million
treatment courses of Tamiflu annually by the end of 2006, a more than
ten-fold increase since 2004. Established by Roche at the request of the
U.S. Department of Health & Human Services (HHS), the U.S. supply chain,
which includes Roche sites as well as external contractors, encompasses all
aspects of Tamiflu production, from synthesis of the initial starting
material (shikimic acid) through all major steps of manufacturing to
finished packs.
"The ability to produce Tamiflu from start to finish on U.S. soil is a
significant milestone that will help ensure access to Tamiflu when and
where it is needed," said George Abercrombie, President and CEO,
Hoffmann-La Roche Inc. "This most recent expansion further demonstrates
Roche's long term commitment to serving as a responsible and collaborative
partner with the U.S. government on pandemic preparedness and response."
Tamiflu is approved for the prevention and treatment of influenza in
adults and children one year and older. Tamiflu is designed to be active
against all clinically relevant influenza viruses, including the H5N1
virus, and has been shown to be active against the H5N1 virus in the
laboratory and in animals infected with the H5N1 strain taken from humans.
To date, HHS has ordered 21.3 million courses of Tamiflu for the U.S.
Strategic National Stockpile, which will be delivered in full this year.
The total targeted U.S. stockpile is 81 million antiviral treatment courses
by the end of 2008; HHS plans to purchase 50 million treatment courses and
subsidize by 25 percent the states' purchases of 31 million courses.
The initial starting material for Tamiflu, shikimic acid, is extracted
in one of two ways: from the pods of the star anise or via a fermentation
process. The majority of shikimic acid used in Tamiflu today is derived by
fermentation, reducing reliance on scarce natural sources.
"U.S.-based sources for key steps in the manufacturing process have
been qualified, and have demonstrated the ability to produce at targeted
rates for both the U.S. and globally," explains Jan van Koeveringe, head of
global technical operations at Roche.
Comprehensive Global Production Network
Roche's global manufacturing network includes several Roche sites and
more than 16 external contractors located in ten different countries. Roche
has received and is filling on schedule orders from more than 75 countries
to-date for stockpiling Tamiflu, and its capacity currently outstrips
demand.
Roche has granted sub-licenses to Shanghai Pharmaceutical Group and to
HEC Group for the overall production of oseltamivir for pandemic use in
China, as well as to India's Hetero Drugs to make oseltamivir for India and
developing countries. Roche has also reached an agreement with Aspen for
providing oseltamivir for pandemic use to further help to address the needs
of governments and other not for profit organizations in the African
sub-continent. Additionally, Roche has donated a total of 5.1 million
Tamiflu treatment courses to the World Health Organization (WHO) for use as
rapid stockpiles and regional stockpiles to respond to bird flu outbreaks.
About Tamiflu
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City,
CA, is a systemic treatment for the most common strains of influenza (types
A and B). Tamiflu is indicated for the treatment of uncomplicated acute
influenza caused by virus types A and B in patients one year and older who
have been symptomatic for no more than two days. Tamiflu is also indicated
for the prophylaxis of influenza in patients one year and older.
In treatment studies in adult patients, the most frequently reported
adverse events (incidence >1%) were nausea and vomiting. Other events
reported numerically more frequently in patients taking Tamiflu compared
with placebo were bronchitis, insomnia and vertigo. In treatment studies in
patients one to 12 years old, the most frequently reported adverse event
(incidence >1%) was vomiting. Other events reported more frequently in
patients taking Tamiflu compared with placebo included abdominal pain,
epistaxis, ear disorder and conjunctivitis.
In prophylaxis studies in adult patients, adverse events were similar
to those seen in the treatment studies. Events reported more frequently in
patients taking Tamiflu compared with placebo (incidence >1%) were nausea,
vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a
household prophylaxis trial that included patients one to 12 years old,
adverse events were consistent with those observed in pediatric treatment
studies, with GI events being the most frequently observed.
Treatment efficacy in subjects with chronic cardiac and/or respiratory
disease has not been established. No difference in the incidence of
complications was observed between the treatment and placebo groups in this
population. Safety and efficacy of repeated treatment or prophylaxis
courses have not been studied.
In post-marketing experience, rare cases of anaphylaxis and serious
skin reactions, including toxic epidermal necrolysis, Stevens-Johnson
syndrome and erythema multiforme, have been reported with Tamiflu.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80
countries worldwide.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
rocheusa or roche.us.
Roche
rocheusa
roche.us
View drug information on Tamiflu capsule.
Keep Your Cats Indoors, Germans Told
People who live near areas where bird flu has been found in Germany are being told by authorities to keep their cats indoors and only take their dogs out on a lead (leash).
This is in response to the discovery of a bird flu infected cat found on the Island of Ruegen, just off the northern coast of Germany. Some H5N1 infected swans had also been found on Ruegen Island a few days ago.
Any state in Germany that has had infected birds will implement this order for dogs and cats, said Deputy Agriculture Minister, Gerd Lindermann. He added that there is no suitable vaccine which protects cats from bird flu.
German veterinarians believe the infected cat had eaten parts of a sick bird.
If cats can catch bird flu, this adds a new dimension to the problem of human infection. In Western Europe very few people bring their poultry indoors - but tens of millions of families have a cat at home. If humans can catch bird flu from a cat, this could add a new twist to the spread and development of the virus.
Written by:
This is in response to the discovery of a bird flu infected cat found on the Island of Ruegen, just off the northern coast of Germany. Some H5N1 infected swans had also been found on Ruegen Island a few days ago.
Any state in Germany that has had infected birds will implement this order for dogs and cats, said Deputy Agriculture Minister, Gerd Lindermann. He added that there is no suitable vaccine which protects cats from bird flu.
German veterinarians believe the infected cat had eaten parts of a sick bird.
If cats can catch bird flu, this adds a new dimension to the problem of human infection. In Western Europe very few people bring their poultry indoors - but tens of millions of families have a cat at home. If humans can catch bird flu from a cat, this could add a new twist to the spread and development of the virus.
Written by:
Sinovac Initiates Phase II Volunteer Enrollment For Split Viron Pandemic Influenza (H5N1) Vaccine
Sinovac Biotech Ltd. (Amex:
SVA), a leading provider of vaccines in China, announced the
initiation of volunteer enrollment in its Phase II clinical trial for its
split pandemic influenza vaccine. The preliminary results from this study
are expected to be available in early 2009.
The randomized and double-blind trial is expected to enroll 210
adolescents, between the ages of 12 to 17, who will receive doses of 10ug,
15ug or 30ug, and 140 children, between the ages of 3 to 11, who will
receive doses of 10ug or 15ug. Volunteers will be followed for two months
with safety and immunogenicity data collected for the assessment of the
vaccine.
Mr. Weidong Yin, Chairman, President and CEO, commented, ''Split
influenza vaccine is believed to cause less adverse reactions in children
compared to whole-viron influenza vaccine. Sinovac's split pandemic
influenza vaccine aims at protecting the pediatric and adolescent
population. Based on the positive safety results of the Phase I trial, the
Phase II study will be conducted to further collect the vaccine's safety
data in children and adolescents, as well as assessing the immunogenicity
of different doses.''
Sinovac received approval from the China State Food and Drug
Administration (SFDA) in April 2007 to conduct clinical trials for two
types of the H5N1 vaccine, namely Phase Ib and II trials of the H5N1 whole
viron vaccine and Phase I and Phase II trials of the H5N1 split vaccine. In
December 2007, Sinovac reported positive top-line results from the
completed Phase II clinical trial of Panflu(TM), its pandemic influenza
(H5N1) whole viron inactivated vaccine. In April 2008, Panflu(TM) was
granted a production license by the China State Food and Drug
Administration (SFDA). Panflu(TM) is the first and only approved vaccine
available in China against the H5N1 influenza virus.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that
focuses on the research, development, manufacture and commercialization of
vaccines that protect against human infectious diseases. Sinovac's
commercialized vaccines include Healive(R) (hepatitis A), Bilive(R)
(combined hepatitis A and B), Anflu(R) (influenza) and Panflu(TM) (H5N1).
Sinovac is currently developing Universal Pandemic Influenza vaccine and
Japanese encephalitis vaccine. Additional information about Sinovac is
available on its website, sinovac.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements
are made under the "safe harbor" provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These forward-looking statements can be
identified by words or phrases such as "will," "expects," "anticipates,"
"future," "intends," "plans," "believes," "estimates" and similar
statements. Among other things, the business outlook and quotations from
management in this press release contain forward-looking statements.
Statements that are not historical facts, including statements about
Sinovac's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and uncertainties. A
number of important factors could cause actual results to differ materially
from those contained in any forward-looking statement. Sinovac does not
undertake any obligation to update any forward-looking statement, except as
required under applicable law.
Sinovac Biotech Ltd.
sinovac
SVA), a leading provider of vaccines in China, announced the
initiation of volunteer enrollment in its Phase II clinical trial for its
split pandemic influenza vaccine. The preliminary results from this study
are expected to be available in early 2009.
The randomized and double-blind trial is expected to enroll 210
adolescents, between the ages of 12 to 17, who will receive doses of 10ug,
15ug or 30ug, and 140 children, between the ages of 3 to 11, who will
receive doses of 10ug or 15ug. Volunteers will be followed for two months
with safety and immunogenicity data collected for the assessment of the
vaccine.
Mr. Weidong Yin, Chairman, President and CEO, commented, ''Split
influenza vaccine is believed to cause less adverse reactions in children
compared to whole-viron influenza vaccine. Sinovac's split pandemic
influenza vaccine aims at protecting the pediatric and adolescent
population. Based on the positive safety results of the Phase I trial, the
Phase II study will be conducted to further collect the vaccine's safety
data in children and adolescents, as well as assessing the immunogenicity
of different doses.''
Sinovac received approval from the China State Food and Drug
Administration (SFDA) in April 2007 to conduct clinical trials for two
types of the H5N1 vaccine, namely Phase Ib and II trials of the H5N1 whole
viron vaccine and Phase I and Phase II trials of the H5N1 split vaccine. In
December 2007, Sinovac reported positive top-line results from the
completed Phase II clinical trial of Panflu(TM), its pandemic influenza
(H5N1) whole viron inactivated vaccine. In April 2008, Panflu(TM) was
granted a production license by the China State Food and Drug
Administration (SFDA). Panflu(TM) is the first and only approved vaccine
available in China against the H5N1 influenza virus.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that
focuses on the research, development, manufacture and commercialization of
vaccines that protect against human infectious diseases. Sinovac's
commercialized vaccines include Healive(R) (hepatitis A), Bilive(R)
(combined hepatitis A and B), Anflu(R) (influenza) and Panflu(TM) (H5N1).
Sinovac is currently developing Universal Pandemic Influenza vaccine and
Japanese encephalitis vaccine. Additional information about Sinovac is
available on its website, sinovac.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements
are made under the "safe harbor" provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These forward-looking statements can be
identified by words or phrases such as "will," "expects," "anticipates,"
"future," "intends," "plans," "believes," "estimates" and similar
statements. Among other things, the business outlook and quotations from
management in this press release contain forward-looking statements.
Statements that are not historical facts, including statements about
Sinovac's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and uncertainties. A
number of important factors could cause actual results to differ materially
from those contained in any forward-looking statement. Sinovac does not
undertake any obligation to update any forward-looking statement, except as
required under applicable law.
Sinovac Biotech Ltd.
sinovac
Moscow Bird Flu From A Single Market
According to the Russian Agriculture Ministry, the Moscow bird flu outbreak was traced to a market southwest of the city. The market is now closed, the Ministry told AP, while scientists try to find out where the four dead birds came from.
Although H5N1 is suspected, further laboratory tests need to confirm this. It will be the first H5N1 bird flu outbreak in the Moscow area if tests results come back positive. Whether of not H5N1 has been confirmed is slightly confusing at the moment - some officials say tests have come back positive while others deny this. While a Ministry spokesman, Alexei Alexeyenko, has confirmed H5N1 was present in two places, Valery Sitnikox, Moscow's Chief Veterinary Inspector, say we won't know about the lab test results until Monday, February 19th.
Valery Sitnikox said authorities in the central Moscow region have implemented all measures to stem the spread of bird flu. "The situation is under control - the veterinary service is in control of everything. Measures to vaccinate birds will begin tomorrow." He added that current measures will make sure further outbreaks can be prevented. He is extremely hopeful that the current chain of events have been stopped - the market where the infected birds were brought to has been shut down.
Nobody knows where the infected birds came from. Authorities stressed that this outbreak poses no threat to human health.
Scientists fear that the H5N1 bird flu virus strain, the most virulent one, will eventually mutate and become easily human transmissible. This has not happened yet. It is extremely difficult for birds to infect humans, and even harder for a human to infect another human.
It is believed that one of the ways H5N1 could mutate would be by infecting a person who is sick with the normal human flu virus. The bird flu virus would then have the opportunity to exchange genetic information with the bird flu virus and acquire its ability to spread easily from human-to-human (become easily human transmissible). If this happened, we could be facing a serious, global flu pandemic.
If we can keep the number of outbreaks among birds down to a minimum, then the number of humans becoming infected is also low - giving the bird flu virus fewer opportunities to mutate.
Written by:
Although H5N1 is suspected, further laboratory tests need to confirm this. It will be the first H5N1 bird flu outbreak in the Moscow area if tests results come back positive. Whether of not H5N1 has been confirmed is slightly confusing at the moment - some officials say tests have come back positive while others deny this. While a Ministry spokesman, Alexei Alexeyenko, has confirmed H5N1 was present in two places, Valery Sitnikox, Moscow's Chief Veterinary Inspector, say we won't know about the lab test results until Monday, February 19th.
Valery Sitnikox said authorities in the central Moscow region have implemented all measures to stem the spread of bird flu. "The situation is under control - the veterinary service is in control of everything. Measures to vaccinate birds will begin tomorrow." He added that current measures will make sure further outbreaks can be prevented. He is extremely hopeful that the current chain of events have been stopped - the market where the infected birds were brought to has been shut down.
Nobody knows where the infected birds came from. Authorities stressed that this outbreak poses no threat to human health.
Scientists fear that the H5N1 bird flu virus strain, the most virulent one, will eventually mutate and become easily human transmissible. This has not happened yet. It is extremely difficult for birds to infect humans, and even harder for a human to infect another human.
It is believed that one of the ways H5N1 could mutate would be by infecting a person who is sick with the normal human flu virus. The bird flu virus would then have the opportunity to exchange genetic information with the bird flu virus and acquire its ability to spread easily from human-to-human (become easily human transmissible). If this happened, we could be facing a serious, global flu pandemic.
If we can keep the number of outbreaks among birds down to a minimum, then the number of humans becoming infected is also low - giving the bird flu virus fewer opportunities to mutate.
Written by:
European Medicines Agency Meets With Avian Flu Vaccine Manufacturers
The European Medicines Agency has met with avian influenza vaccine manufacturers, European veterinary vaccine experts and representatives from the European Commission to promote the availability of authorised influenza vaccines for birds in the European Union.
The meeting held at the Agency's offices in London on 8 March 2006 considered the recent reflection paper from the Agency's Committee for Medicinal Products for Veterinary Use (CVMP) on data requirements for emergency avian influenza vaccines. There was consensus from all parties that the reflection paper should be developed into a full guideline as a priority.
As part of the Agency's preparedness for avian influenza, Thomas Lцnngren, the Agency's Executive Director, has agreed to grant fee waivers for all applications made to the Agency for avian influenza vaccines. Waivers will be given for scientific advice, follow-up scientific advice, applications for marketing authorisation and variations relating to the pandemic use of the vaccine.
The CVMP has also recently adopted a guideline on accelerated assessment, which can be used by applicants for avian influenza vaccines. It was confirmed that the CVMP is committed to reviewing any application as quickly as possible, while still ensuring a scientifically sound and thorough assessment.
The meeting with interested parties is part of the Agency and the Committee's ambition to provide a clear route to rapid approval of influenza vaccines for use in birds throughout the European Union. This should in turn ensure the availability of safe and effective vaccines to Member States where they decide to use emergency vaccination within the context of their national control programmes against avian influenza.
The CVMP reflection paper on minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus (EMEA/CVMP/IWP/46853/2006) was published on 16 February 2006 and can be found HERE.
This press release, together with other information on the work of the European Medicines Agency, can be found on the EMEA website: emea.eu
The meeting held at the Agency's offices in London on 8 March 2006 considered the recent reflection paper from the Agency's Committee for Medicinal Products for Veterinary Use (CVMP) on data requirements for emergency avian influenza vaccines. There was consensus from all parties that the reflection paper should be developed into a full guideline as a priority.
As part of the Agency's preparedness for avian influenza, Thomas Lцnngren, the Agency's Executive Director, has agreed to grant fee waivers for all applications made to the Agency for avian influenza vaccines. Waivers will be given for scientific advice, follow-up scientific advice, applications for marketing authorisation and variations relating to the pandemic use of the vaccine.
The CVMP has also recently adopted a guideline on accelerated assessment, which can be used by applicants for avian influenza vaccines. It was confirmed that the CVMP is committed to reviewing any application as quickly as possible, while still ensuring a scientifically sound and thorough assessment.
The meeting with interested parties is part of the Agency and the Committee's ambition to provide a clear route to rapid approval of influenza vaccines for use in birds throughout the European Union. This should in turn ensure the availability of safe and effective vaccines to Member States where they decide to use emergency vaccination within the context of their national control programmes against avian influenza.
The CVMP reflection paper on minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus (EMEA/CVMP/IWP/46853/2006) was published on 16 February 2006 and can be found HERE.
This press release, together with other information on the work of the European Medicines Agency, can be found on the EMEA website: emea.eu
Bird Flu Vaccine Protects Half The People Who Take It
According to researchers, a new experimental bird flu (avian flu) vaccine protects 54% of people who get two shots at a very high dose (90 micrograms). This dose is twelve times higher than that needed for protection from normal human flu.
You can read about this research in the New England Journal of Medicine (NEJM).
451 volunteers took part in this trial.
70% of those who got the shot had some kind of immune response, however, it was not possible to know how protective this response might be, said the researchers.
According to Dr. J Treanor, University of Rochester, New York, even at such a high dose, the vaccine seems to be completely safe for humans. He also added that as nearly all humans have not been exposed to H5N1 at all, developing an immune response takes time.
Whether or not a third dose may up the immune response of more participants remains to be seen. The scientists say they plan to administer a third dose. They also said that by adding such chemicals as alum or MF59, it may be possible to lower the dose.
As there are now two types of H5N1 virus strains, it is not known whether this vaccine offers protection from both.
The vaccine is made by Sanofi-Aventis and was developed from a H5N1 virus strain obtained in Vietnam two years ago.
For a human to become ill as a result of H5N1 infection, the virus has to make its way deep into the lungs. This is why humans cannot catch bird flu easily and cannot easily transmit it to other humans. An infected person who coughs or sneezes expels hardly any of the viruses (because they are too deep inside the lungs). If the virus mutates, so that it can easily be transmitted from human-to-human, it will need to attack the upper parts of the lungs. If it manages to do this, it will be much easier to treat.
Written by:
You can read about this research in the New England Journal of Medicine (NEJM).
451 volunteers took part in this trial.
70% of those who got the shot had some kind of immune response, however, it was not possible to know how protective this response might be, said the researchers.
According to Dr. J Treanor, University of Rochester, New York, even at such a high dose, the vaccine seems to be completely safe for humans. He also added that as nearly all humans have not been exposed to H5N1 at all, developing an immune response takes time.
Whether or not a third dose may up the immune response of more participants remains to be seen. The scientists say they plan to administer a third dose. They also said that by adding such chemicals as alum or MF59, it may be possible to lower the dose.
As there are now two types of H5N1 virus strains, it is not known whether this vaccine offers protection from both.
The vaccine is made by Sanofi-Aventis and was developed from a H5N1 virus strain obtained in Vietnam two years ago.
For a human to become ill as a result of H5N1 infection, the virus has to make its way deep into the lungs. This is why humans cannot catch bird flu easily and cannot easily transmit it to other humans. An infected person who coughs or sneezes expels hardly any of the viruses (because they are too deep inside the lungs). If the virus mutates, so that it can easily be transmitted from human-to-human, it will need to attack the upper parts of the lungs. If it manages to do this, it will be much easier to treat.
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FDA Initiative Helps Expedite Development Of Seasonal And Pandemic Flu Vaccines
The Food and Drug Administration (FDA) today issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. FDA's goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza.
"This action illustrates FDA's high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation" said Acting FDA Commissioner Dr. Andrew von Eschenbach.
In two guidance documents released today, one for seasonal, and the other for pandemic influenza vaccines, the FDA provides manufacturers with clear guidance on developing and submitting clinical data to show safety and effectiveness for new vaccines. Consistent with the aims of FDA's Critical Path Initiative to get products to market more quickly and to advance the development and use of new technologies, these documents outline specific approaches that vaccine developers may follow.
For licensed vaccines, they describe the process for changing rapidly from the currently-licensed seasonal vaccine to a new pandemic vaccine by supplementing the existing license. For new vaccines, they describe defined pathways for both traditional and accelerated approval approaches. Accelerated approval allows for evaluation based on biological indicators (e.g., the immune response to the vaccine) likely to demonstrate effectiveness.
Because these guidances will assist manufacturers in the development and evaluation of seasonal and pandemic influenza, the direction that they provide to new manufacturers, in turn, helps address the increased demand for influenza vaccine. The guidance also helps support and defines steps needed for development and evaluation of vaccines using new technologies (such as cell culture and recombinant manufacturing) and potential approaches to stretching limited pandemic vaccine supplies (such as with the use of ingredients added to a vaccine to improve the immune response it produces, known as adjuvants and different vaccine delivery methods).
The accelerated approval pathway was critical in allowing last year's rapid approval of a new influenza vaccine, Fluarix, and broke new ground in that it was the first vaccine approved using that approval process.
In issuing this advice, FDA aims to facilitate manufacturers in increasing the number of doses to ensure that enough influenza vaccine is available to vaccinate each person in the at-risk population. Having additional diversity in our vaccine supply helps enhance the capacity to produce more doses of influenza vaccine and contributes to the nation's pandemic preparedness.
"These guidance documents provide important advice for manufacturers on how to develop needed vaccines more quickly," said Dr. Jesse Goodman, Director of the Center for Biologics Evaluation and Research, FDA. "FDA is committed to helping companies develop safe and effective vaccines to prevent influenza, including pandemic influenza, and is very engaged with product developers."
The release of these guidances is part of the comprehensive effort that FDA is undertaking to work with manufacturers to facilitate the development of vaccines. Other examples include a recent CBER advisory committee meeting to discuss novel approaches to develop influenza vaccine such as using cell technology rather than eggs, frequent interactions with vaccine manufacturers to provide both scientific and regulatory guidance, as well as CBER's preparation of material for testing the potency of new vaccines, which are made available to manufacturers.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines," is available at: fda/cber/gdlns/trifluvac.pdf.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines," is available at: fda/cber/gdlns/panfluvac.pdf.
The public has 90 days to comment on the drafts. When finalized, the guidances will represent the FDA's current thinking on these topics.
fda
"This action illustrates FDA's high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation" said Acting FDA Commissioner Dr. Andrew von Eschenbach.
In two guidance documents released today, one for seasonal, and the other for pandemic influenza vaccines, the FDA provides manufacturers with clear guidance on developing and submitting clinical data to show safety and effectiveness for new vaccines. Consistent with the aims of FDA's Critical Path Initiative to get products to market more quickly and to advance the development and use of new technologies, these documents outline specific approaches that vaccine developers may follow.
For licensed vaccines, they describe the process for changing rapidly from the currently-licensed seasonal vaccine to a new pandemic vaccine by supplementing the existing license. For new vaccines, they describe defined pathways for both traditional and accelerated approval approaches. Accelerated approval allows for evaluation based on biological indicators (e.g., the immune response to the vaccine) likely to demonstrate effectiveness.
Because these guidances will assist manufacturers in the development and evaluation of seasonal and pandemic influenza, the direction that they provide to new manufacturers, in turn, helps address the increased demand for influenza vaccine. The guidance also helps support and defines steps needed for development and evaluation of vaccines using new technologies (such as cell culture and recombinant manufacturing) and potential approaches to stretching limited pandemic vaccine supplies (such as with the use of ingredients added to a vaccine to improve the immune response it produces, known as adjuvants and different vaccine delivery methods).
The accelerated approval pathway was critical in allowing last year's rapid approval of a new influenza vaccine, Fluarix, and broke new ground in that it was the first vaccine approved using that approval process.
In issuing this advice, FDA aims to facilitate manufacturers in increasing the number of doses to ensure that enough influenza vaccine is available to vaccinate each person in the at-risk population. Having additional diversity in our vaccine supply helps enhance the capacity to produce more doses of influenza vaccine and contributes to the nation's pandemic preparedness.
"These guidance documents provide important advice for manufacturers on how to develop needed vaccines more quickly," said Dr. Jesse Goodman, Director of the Center for Biologics Evaluation and Research, FDA. "FDA is committed to helping companies develop safe and effective vaccines to prevent influenza, including pandemic influenza, and is very engaged with product developers."
The release of these guidances is part of the comprehensive effort that FDA is undertaking to work with manufacturers to facilitate the development of vaccines. Other examples include a recent CBER advisory committee meeting to discuss novel approaches to develop influenza vaccine such as using cell technology rather than eggs, frequent interactions with vaccine manufacturers to provide both scientific and regulatory guidance, as well as CBER's preparation of material for testing the potency of new vaccines, which are made available to manufacturers.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines," is available at: fda/cber/gdlns/trifluvac.pdf.
A copy of the guidance, "Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines," is available at: fda/cber/gdlns/panfluvac.pdf.
The public has 90 days to comment on the drafts. When finalized, the guidances will represent the FDA's current thinking on these topics.
fda
Study Finds Antivirals Effectively Curb Influenza Virus And Are Valuable In Managing Seasonal Flu In Households
Two antiviral drugs, oseltamivir and
zanamivir, are highly effective when given as a preventive measure to
reduce the spread of the influenza virus, according to an analysis of
household-based studies by researchers at Fred Hutchinson Cancer Research
Center, University of Michigan and University of Virginia, published in the
current print edition of the American Journal of Epidemiology. The analysis
also suggests that treatment with oseltamivir may reduce the infectiousness
of influenza patients, although further studies are needed to provide a
definitive conclusion.
"Preventing the spread of influenza within families is an essential
part of influenza management, regardless of the strain. This study shows
that there is a clear benefit to be gained by giving antivirals to people
who have been exposed to the virus to prevent the onset of symptomatic
illness," said lead author M. Elizabeth (Betz) Halloran, M.D., D.Sc., a
Hutchinson Center-based biostatistician.
"While the efficacy of antivirals to protect against influenza is
critical, the effect of these drugs on infectiousness also has important
public-health consequences. Further studies to determine antiviral efficacy
for reducing infectiousness would therefore be of great value," said
Halloran, a member of the Hutchinson Center's Public Health Sciences
Division and a professor of biostatistics at the University of Washington
School of Public Health and Community Medicine.
The report evaluated four household-based, randomized,
placebo-controlled clinical trials, conducted from 2000 to 2004, which were
designed to estimate the effect of post-exposure antiviral treatment on
preventing influenza within households. Two of the trials were conducted
with zanamivir and two with oseltamivir, permitting comparisons to be made
between the two. The trials covered a total of 1,475 households. The
majority of first household cases (53 percent to 70 percent) had influenza
A (H3N2 or H1N1).
The authors reviewed the effects of each antiviral on infectiousness
and pathogenicity -- the ability of the influenza virus to cause overt
disease. Pathogenicity in controls ranged from 44 percent to 66 percent.
Efficacy in reducing pathogenicity for zanamivir was 52 percent and 56
percent in the two zanamivir studies; for oseltamivir, it was 56 percent
and 79 percent. The researchers found that both drugs were highly
preventive against influenza illness, with oseltamivir at 81 percent
efficacy and zanamivir at 75 percent. Thus, the preventive use of either
product reduced by 75 percent to 81 percent the chance that an exposed
person would become ill with influenza.
The researchers' analysis found a significant reduction in
infectiousness, as defined by reductions in influenza illnesses in
household contacts, when oseltamivir was used for treatment of ill persons,
but not when zanamivir was administered. Although these results are of
interest, the authors stress that the numbers were small and combined
estimates from two studies for each drug were used in both instances.
Furthermore, oseltamivir treatment of ill persons did not appear to reduce
the frequency of influenza infection in their contacts.
In exploring the reasons for oseltamivir's greater effects on
infectiousness, the authors speculated that the different modes of
administration -- oral for oseltamivir and inhaled for zanamivir -- and
resultant upper-respiratory viral levels could be the key, with zanamivir
not reaching or affecting influenza virus in the nose. While both
antivirals reduced cough, in earlier studies inhaled zanamivir did not
significantly reduce nasal symptoms. In the paper the authors discussed the
possibility that infectious droplets inhaled and exhaled from the nose may
be important in viral transmission, thus orally administered oseltamivir
might have an advantage in limiting spread.
In addressing the limitations to their research, the authors call for
further studies into antiviral efficacy. "Trials in non-household settings
where influenza readily spreads -- such as schools, homes for the elderly
and workplaces -- would be beneficial not only for planning management of
seasonal influenza but also would be invaluable in pandemic planning.
Additionally, simple solutions such as standardized randomization and study
criteria would greatly facilitate trial comparison in the future. Such
further studies will help us ensure we are better prepared not only for
annual influenza seasons but also for the ultimate pandemic," said
co-author Ira M. Longini, Jr., Ph.D., also a member of the Hutchinson
Center's Public Health Sciences Division and a biostatistics professor at
the University of Washington.
This research was partially supported by a National Institute of
Allergy and Infectious Disease grant and a National Institute of General
Medical Sciences MIDAS grant. Roche and GlaxoSmithKline allowed access to
the necessary data sets.
At Fred Hutchinson Cancer Research Center our interdisciplinary teams
of world-renowned scientists and humanitarians work together to prevent,
diagnose and treat cancer. Center researchers, including three Nobel
laureates, bring a relentless pursuit and passion for health, knowledge and
hope to their work and to the world. For more information, please visit
fhcrc.
BACKGROUND INFORMATION
About influenza
Influenza, commonly called the "flu," is a serious disease and annual
outbreaks and epidemics are caused by influenza A and B viruses. Influenza
is a highly contagious viral illness and is characterized by a sudden onset
of debilitating clinical symptoms that affect the entire body. Up to 500
million people are infected by influenza and up to 500,000 deaths are
attributed to influenza each year. Influenza complications occur in all
patient groups and include bronchitis, sinusitis, otitis media, and
pneumonia.
About oseltamivir and zanamivir
Oseltamivir (brand name Tamiflu) and zanamivir (brand name Relenza) are
neuraminidase inhibitors and are active against all clinically relevant
influenza viruses. They work by blocking the action of the neuraminidase
enzyme on the surface of the virus. When neuraminidase is inhibited, the
virus is unable to spread to and infect other cells in the body.
Oseltamivir is administered orally and is licensed for the treatment and
prevention of influenza in adults and in children aged 1 year and above.
Zanamivir is administered by oral inhalation. Zanamivir is registered in
the United States for the treatment of influenza in adults and children
aged 7 years or above, and for the prevention of influenza in adults and
children aged 5 years or above.
About the World Health Organization global influenza program:
who.int/csr/disease/influenza/en/
About the World Health Organization - avian flu:
who.int/mediacentre/factsheets/avian_influenza/en/
About the WHO Rapid Advice Guidelines on pharmacological management of
humans infected with avian influenza A (H5N1) virus:
who.int/csr/disease/avian_influenza/guidelines/pharmamanagement/
Fred Hutchinson Cancer Research Center
fhcrc/
View drug information on Relenza; Tamiflu capsule.
zanamivir, are highly effective when given as a preventive measure to
reduce the spread of the influenza virus, according to an analysis of
household-based studies by researchers at Fred Hutchinson Cancer Research
Center, University of Michigan and University of Virginia, published in the
current print edition of the American Journal of Epidemiology. The analysis
also suggests that treatment with oseltamivir may reduce the infectiousness
of influenza patients, although further studies are needed to provide a
definitive conclusion.
"Preventing the spread of influenza within families is an essential
part of influenza management, regardless of the strain. This study shows
that there is a clear benefit to be gained by giving antivirals to people
who have been exposed to the virus to prevent the onset of symptomatic
illness," said lead author M. Elizabeth (Betz) Halloran, M.D., D.Sc., a
Hutchinson Center-based biostatistician.
"While the efficacy of antivirals to protect against influenza is
critical, the effect of these drugs on infectiousness also has important
public-health consequences. Further studies to determine antiviral efficacy
for reducing infectiousness would therefore be of great value," said
Halloran, a member of the Hutchinson Center's Public Health Sciences
Division and a professor of biostatistics at the University of Washington
School of Public Health and Community Medicine.
The report evaluated four household-based, randomized,
placebo-controlled clinical trials, conducted from 2000 to 2004, which were
designed to estimate the effect of post-exposure antiviral treatment on
preventing influenza within households. Two of the trials were conducted
with zanamivir and two with oseltamivir, permitting comparisons to be made
between the two. The trials covered a total of 1,475 households. The
majority of first household cases (53 percent to 70 percent) had influenza
A (H3N2 or H1N1).
The authors reviewed the effects of each antiviral on infectiousness
and pathogenicity -- the ability of the influenza virus to cause overt
disease. Pathogenicity in controls ranged from 44 percent to 66 percent.
Efficacy in reducing pathogenicity for zanamivir was 52 percent and 56
percent in the two zanamivir studies; for oseltamivir, it was 56 percent
and 79 percent. The researchers found that both drugs were highly
preventive against influenza illness, with oseltamivir at 81 percent
efficacy and zanamivir at 75 percent. Thus, the preventive use of either
product reduced by 75 percent to 81 percent the chance that an exposed
person would become ill with influenza.
The researchers' analysis found a significant reduction in
infectiousness, as defined by reductions in influenza illnesses in
household contacts, when oseltamivir was used for treatment of ill persons,
but not when zanamivir was administered. Although these results are of
interest, the authors stress that the numbers were small and combined
estimates from two studies for each drug were used in both instances.
Furthermore, oseltamivir treatment of ill persons did not appear to reduce
the frequency of influenza infection in their contacts.
In exploring the reasons for oseltamivir's greater effects on
infectiousness, the authors speculated that the different modes of
administration -- oral for oseltamivir and inhaled for zanamivir -- and
resultant upper-respiratory viral levels could be the key, with zanamivir
not reaching or affecting influenza virus in the nose. While both
antivirals reduced cough, in earlier studies inhaled zanamivir did not
significantly reduce nasal symptoms. In the paper the authors discussed the
possibility that infectious droplets inhaled and exhaled from the nose may
be important in viral transmission, thus orally administered oseltamivir
might have an advantage in limiting spread.
In addressing the limitations to their research, the authors call for
further studies into antiviral efficacy. "Trials in non-household settings
where influenza readily spreads -- such as schools, homes for the elderly
and workplaces -- would be beneficial not only for planning management of
seasonal influenza but also would be invaluable in pandemic planning.
Additionally, simple solutions such as standardized randomization and study
criteria would greatly facilitate trial comparison in the future. Such
further studies will help us ensure we are better prepared not only for
annual influenza seasons but also for the ultimate pandemic," said
co-author Ira M. Longini, Jr., Ph.D., also a member of the Hutchinson
Center's Public Health Sciences Division and a biostatistics professor at
the University of Washington.
This research was partially supported by a National Institute of
Allergy and Infectious Disease grant and a National Institute of General
Medical Sciences MIDAS grant. Roche and GlaxoSmithKline allowed access to
the necessary data sets.
At Fred Hutchinson Cancer Research Center our interdisciplinary teams
of world-renowned scientists and humanitarians work together to prevent,
diagnose and treat cancer. Center researchers, including three Nobel
laureates, bring a relentless pursuit and passion for health, knowledge and
hope to their work and to the world. For more information, please visit
fhcrc.
BACKGROUND INFORMATION
About influenza
Influenza, commonly called the "flu," is a serious disease and annual
outbreaks and epidemics are caused by influenza A and B viruses. Influenza
is a highly contagious viral illness and is characterized by a sudden onset
of debilitating clinical symptoms that affect the entire body. Up to 500
million people are infected by influenza and up to 500,000 deaths are
attributed to influenza each year. Influenza complications occur in all
patient groups and include bronchitis, sinusitis, otitis media, and
pneumonia.
About oseltamivir and zanamivir
Oseltamivir (brand name Tamiflu) and zanamivir (brand name Relenza) are
neuraminidase inhibitors and are active against all clinically relevant
influenza viruses. They work by blocking the action of the neuraminidase
enzyme on the surface of the virus. When neuraminidase is inhibited, the
virus is unable to spread to and infect other cells in the body.
Oseltamivir is administered orally and is licensed for the treatment and
prevention of influenza in adults and in children aged 1 year and above.
Zanamivir is administered by oral inhalation. Zanamivir is registered in
the United States for the treatment of influenza in adults and children
aged 7 years or above, and for the prevention of influenza in adults and
children aged 5 years or above.
About the World Health Organization global influenza program:
who.int/csr/disease/influenza/en/
About the World Health Organization - avian flu:
who.int/mediacentre/factsheets/avian_influenza/en/
About the WHO Rapid Advice Guidelines on pharmacological management of
humans infected with avian influenza A (H5N1) virus:
who.int/csr/disease/avian_influenza/guidelines/pharmamanagement/
Fred Hutchinson Cancer Research Center
fhcrc/
View drug information on Relenza; Tamiflu capsule.
Avian Influenza, Turkey, 12 Of The 21 H5N1 Cases Confirmed
A WHO collaborating laboratory in the United Kingdom has now confirmed 12 of the 21 cases of H5N1 avian influenza previously announced by the Turkish Ministry of Health. All four fatalities are among the 12 confirmed cases.
Samples from the remaining 9 patients, confirmed as H5 positive in the Ankara laboratory, are undergoing further joint investigation by the Ankara and UK laboratories.
Testing for H5N1 infection is technically challenging, particularly under the conditions of an outbreak where large numbers of samples are submitted for testing and rapid results are needed to guide clinical decisions. Additional testing in a WHO collaborating laboratory may produce inconclusive or only weakly positive results. In such cases, clinical data about the patient are used to make a final assessment.
who.int
Samples from the remaining 9 patients, confirmed as H5 positive in the Ankara laboratory, are undergoing further joint investigation by the Ankara and UK laboratories.
Testing for H5N1 infection is technically challenging, particularly under the conditions of an outbreak where large numbers of samples are submitted for testing and rapid results are needed to guide clinical decisions. Additional testing in a WHO collaborating laboratory may produce inconclusive or only weakly positive results. In such cases, clinical data about the patient are used to make a final assessment.
who.int
Bird flu found among pet chickens in Japan
A strain of Bird Flu (Avian Flu) has been found in pet chickens in Japan in the southern town of Kokonoe.
Seven of the pets died at a private home. They also found that a duck, which was also a pet, tested positive.
These chickens are different from the farm ones; they are smaller and are usually raised as pets.
They were infected with the H5 virus, in the same category as the H5N1 virus that has spread throughout SE Asia.
The owners of the pets have had to undergo tests to make sure they are not infected.
Although avian flu generally only infects birds, it has spread to people in some cases. 14 people in Vietnam and 6 in Thailand have died of bird flu.
So far, China, Cambodia, Japan, Indonesia, Laos, Pakistan, South Korea, Thailand, Taiwan and Vietnam have had birds with avian flu this year. Pakistan and Taiwan have milder cases of the virus.
Seven of the pets died at a private home. They also found that a duck, which was also a pet, tested positive.
These chickens are different from the farm ones; they are smaller and are usually raised as pets.
They were infected with the H5 virus, in the same category as the H5N1 virus that has spread throughout SE Asia.
The owners of the pets have had to undergo tests to make sure they are not infected.
Although avian flu generally only infects birds, it has spread to people in some cases. 14 people in Vietnam and 6 in Thailand have died of bird flu.
So far, China, Cambodia, Japan, Indonesia, Laos, Pakistan, South Korea, Thailand, Taiwan and Vietnam have had birds with avian flu this year. Pakistan and Taiwan have milder cases of the virus.
American Tamiflu Stocks Sent To Unnamed Asian Country
Mike Leavitt, US Health and Human Services Secretary, says US stocks of Tamiflu are being sent to a safe location in some unnamed Asian country. He said this move is to help the first line of defence in case a flu pandemic breaks out.
Many wonder why this sudden move was announced. Why is the country unnamed? Last week it was announced that 7 members of the same family in Indonesia were infected with the H5N1 bird flu strain - six of them died. The World Health Organization said it was unlikely that such a large cluster of human infections was due to human-to-human transmission. However, nobody seems to be able to locate the source of infection.
If a bunch of people get infected and authorities cannot find any birds as the source, it is not illogical to wonder whether these people may have infected each other. When the WHO says this is unlikely, but cannot offer any other explanation regarding the source of infection, people wonder.
Mike Leavitt said the Tamiflu stocks that are being moved from the USA to Asia would belong to the USA - America would control its deployment. We are told the shipment will arrive at the Asian country later this week. We don't know how many Tamiflu doses were sent.
These Tamiflu stocks will help support international containment efforts in case a flu pandemic breaks out in Asia. Mike Leavitt added that the stocks could be sent back to the USA if needed.
Mike Leavitt said the USA will have enough Tamiflu to treat one quarter of the US population in the event of a flu pandemic. However, his figures are based on some hopeful suppositions. By the end of this year the USA will have 26 million treatment courses - less than 10% of the population. By the end of 2007 it will have 75 million treatment courses - 25% of the population. As long as the pandemic does not hit before the end of 2007, in about one year-and-a-half, his supposition will be accurate. However, if it hits before that, he will be short. The USA has a population of about 290 million.
Written by:
View drug information on Tamiflu capsule.
Many wonder why this sudden move was announced. Why is the country unnamed? Last week it was announced that 7 members of the same family in Indonesia were infected with the H5N1 bird flu strain - six of them died. The World Health Organization said it was unlikely that such a large cluster of human infections was due to human-to-human transmission. However, nobody seems to be able to locate the source of infection.
If a bunch of people get infected and authorities cannot find any birds as the source, it is not illogical to wonder whether these people may have infected each other. When the WHO says this is unlikely, but cannot offer any other explanation regarding the source of infection, people wonder.
Mike Leavitt said the Tamiflu stocks that are being moved from the USA to Asia would belong to the USA - America would control its deployment. We are told the shipment will arrive at the Asian country later this week. We don't know how many Tamiflu doses were sent.
These Tamiflu stocks will help support international containment efforts in case a flu pandemic breaks out in Asia. Mike Leavitt added that the stocks could be sent back to the USA if needed.
Mike Leavitt said the USA will have enough Tamiflu to treat one quarter of the US population in the event of a flu pandemic. However, his figures are based on some hopeful suppositions. By the end of this year the USA will have 26 million treatment courses - less than 10% of the population. By the end of 2007 it will have 75 million treatment courses - 25% of the population. As long as the pandemic does not hit before the end of 2007, in about one year-and-a-half, his supposition will be accurate. However, if it hits before that, he will be short. The USA has a population of about 290 million.
Written by:
View drug information on Tamiflu capsule.
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