Contract Award For Purchase Of H5N1 Vaccine, UK Department Of Health

Health Minister, Rosie Winterton today announced the award of
contracts to Baxter and Chiron for supplies of around 3.5 million
doses of H5N1 vaccine. The announcement was made as EU Health
Ministers attended a special meeting in Vienna to take stock of
recent events and discuss coordination action at European level.


The contracts are worth Ј33 million and are part of the work to
prepare for and reduce the impact of a possible flu pandemic. The
vaccine will be used to carry out further research and could also be
used to vaccinate frontline healthcare workers before a specific
pandemic vaccine can be developed.


Health Minister, Rosie Winterton said:


"We take the potential threat posed by pandemic flu very seriously
and as the WHO and a recent Lords Science and Technology Committee
has recognised the UK is among the best prepared countries in the
world. But, we are not complacent and recognise that more work needs
to be done in order to make the country as fully prepared as possible
to meet the threat.


"Today we have announced our intention to award the contract for the
supply of around 3.5 million doses of H5N1 vaccine. Building a
stockpile will allow us to carry out more research and could be
offered as a possible first line of defence for NHS workers whilst
the exact vaccine to match the pandemic flu strain is manufactured.
This is in addition to placing sleeping contracts for 120 million
doses of pandemic vaccine, which will ensure access to the vaccine
once it is developed".


The vaccine is scheduled for delivery in May and October 2006.


1. The tendering exercise was conducted in accordance with the EU
procurement regulations. Five tenders were received and these were
assessed against pre-determined criteria. The tender bids from Baxter
and Chiron were judged to best meet all the required criteria
including technical and scientific requirements as well as providing
the best value for money.


2. The Influenza Pandemic Contingency plan, together with some
explanatory documents, are published on the Department of Health
website at dh.uk.

Experimental Vaccine Protects Mice Against Deadly 1918 Flu Virus

Federal scientists have developed a vaccine that protects mice against the killer 1918 influenza virus. They also have created a technique for identifying antibodies that neutralize this virus, a tool that could help contain future pandemic flu strains. These findings are important, the researchers say, to understanding and preventing the recurrence of the H1N1 influenza virus that caused the 1918 pandemic and to protecting against virulent flu strains in the future, including the H5N1 avian flu virus. Details of the research are available online this week in Proceedings of the National Academy of Sciences.



Gary J. Nabel, M.D., Ph.D., director of the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), led the research team in developing the experimental vaccines and conducting the immunological studies in mice. Terrence Tumpey, Ph.D., of the Centers for Disease Control and Prevention (CDC) conducted vaccine studies in mice involving the live, reconstructed 1918 flu virus in a biosafety level 3-enhanced laboratory at the CDC in Atlanta--one of four types of specialized biosafety labs where scientists study contagious and potentially deadly materials under high-level safety and contamination precautions designed to protect the researchers and prevent microorganisms from entering the environment.



"Understanding why this influenza virus was so deadly is an extremely important question," says NIAID Director Anthony S. Fauci, M.D. "By building upon earlier research where scientists successfully reconstructed the 1918 pandemic flu strain, Dr. Nabel and his colleagues have demonstrated that this virus is vulnerable to intervention. This knowledge will help further our continued efforts to develop treatments and vaccines to protect us against another deadly flu pandemic."



The 1918-1919 influenza pandemic was the most deadly flu outbreak in modern history, killing 50 million or more people worldwide.



"A key to containing pandemic flu viruses is to understand their vulnerabilities and determine whether they can evade immune recognition," says Dr. Nabel. "What we learn about the H1N1 virus that caused the 1918 pandemic is pertinent to other pandemic viruses and to the development of effective and universal vaccines."



Using the genetic sequence information for the 1918 flu virus, Dr. Nabel and his VRC colleagues created plasmids--small strands of DNA designed to express specific characteristics--carrying genes for the virus' hemagglutinin (HA) protein, the surface protein found in all flu viruses that allows the virus to stick to a cell and cause infection. The researchers created two types of plasmids: one to reflect the HA found in the original 1918 flu virus; the other an altered HA protein designed to attenuate (weaken) the virus.
















Mice were then injected with a DNA vaccine containing both types of plasmids to determine whether they would generate immune responses to the 1918 virus. The researchers found significant responses both in terms of production of T-cells, the white blood cells critical in the immune system's battle against invading viruses, as well as the production of neutralizing antibodies.



To determine the vaccine's protective effects, the CDC's Dr. Tumpey intranasally exposed a group of mice to live, reconstructed 1918 virus 14 days after they were immunized with the experimental DNA vaccine. All 10 vaccinated mice survived the challenge with the deadly virus. To explore how the vaccine protected the animals, the researchers first depleted other mice of T-cells; however, this had no effect on the immunity of the vaccinated mice to the 1918 virus. In contrast, the researchers discovered that transferring antibody-rich immunoglobulin (IgG) from immunized mice to non-immunized mice resulted in antibody levels in the animals at levels only slightly lower than those that were immunized. Further, when the animals were exposed to the reconstructed 1918 flu virus, 8 of 10 mice that received antibodies from the immunized mice survived; none of the 10 mice that received IgG from the unvaccinated control group survived.



"By using an existing pandemic flu strain, this research will provide the basis for design of alternative vaccines against influenza viruses with enhanced virulence," says Dr. Tumpey.



Although the researchers are not discounting the potential role T-cells may have in combating flu viruses, they concluded that in this study, the experimental DNA vaccine protected the mice by stimulating antibodies capable of neutralizing the 1918 flu virus.


"Who would have imagined five years ago that we'd be able to create a vaccine that protects against one of the deadliest forms of influenza the world has ever seen?" adds Dr. Nabel. "It's because the 1918 flu virus has been reconstructed that we are now able the further understand it. Hopefully, this virus will help us to develop effective vaccine strategies for current pandemic influenza virus threats."



To evaluate the vaccine's antibody-inducing capabilities while minimizing exposure of lab personnel to the 1918 flu virus, Dr. Nabel and his VRC colleagues also created artificial viruses, or pseudoviruses, featuring the HA of the 1918 flu virus but stripped of the ability to cause infection. The pseudoviruses were then incubated with antibody-containing blood samples from the mice immunized with the DNA vaccine and those that were not. The researchers found that the antibodies from the immunized mice neutralized the pseudoviruses while the blood samples from the mice that were not immunized had no effect. This method was also effective in identifying neutralizing antibodies to the H5N1 avian flu virus and could be used to screen for monoclonal antibodies that may be used as an antiviral treatment, according to Dr. Nabel.



"This technique would be very useful in defining evolving serotypes of flu viruses like H5N1 to develop immune sera and neutralizing monoclonal antibodies that may help to contain pandemic flu," says Dr. Nabel.



The study authors indicate that further testing will be needed to determine whether DNA vaccination can confer immune protection in people similar to that seen in the study mice. Additionally, the use of DNA-based vaccines are being explored as a potential strategy for creating vaccines to protect against the H5N1 avian flu virus.







This research activity is part of a broader effort by the Department of Health and Human Services to accelerate the development and production of new technologies for influenza vaccines within the U.S., including a $1 billion investment earlier this year to support the advanced development of cell-based production technologies for influenza vaccines and will help to modernize and strengthen the nation's influenza vaccine production by creating an alternative to producing influenza vaccines in eggs.



NIAID grantee Adolfo Garcнa-Sastre, Ph.D., of the Mount Sinai School of Medicine in New York, also contributed to the study through his work in reconstructing the virus. In addition to Dr. Nabel, other VRC scientists who contributed to the study include: Wing-Pui Kong, Ph.D.; Chantelle Hood; Zhi-yong Yang; Ling Xu; and Chih-Jen Wei.



NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.



The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visitnih/.



Reference: WP Kong et al. Protective immunity to lethal challenge of the 1918 pandemic influenza virus by vaccination. Proceedings of the National Academy of Sciences DOI: 10.1073/pnas.0607564103 (2006).



News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at niaid.nih/.



Contact: Kathy Stover


NIH/National Institute of Allergy and Infectious Diseases

Bird Flu Medication Route Found In Virus' Weak Point

While mapping the H5N1 avian flu virus, scientists from the National Institute of Research, London, discovered a weakness which could be targeted by drugs.


The N1 part of the virus (type-1 neuraminidase) has a cavity. It might be possible to target drugs into this cavity and stop the virus from spreading, say the scientists.


John Skehel, team leader, said "It is a race. You have got to try to keep ahead of variation, and in the case of H5N1 particularly the emergence of transmission from human to human".


The researchers say this finding could make it possible to treat humans, even in the event of an outbreak. However, they also added that any effective drug would probably take at least five years to come onto the market.


The team are working with pharmaceutical companies to see whether it is possible that new drugs might work in combination with Tamiflu and Relenza.


238 human have become infected with the H5N1 bird flu virus strain - the virulent one. About 60% of those who were infected died. Although most scientists believe H5N1 could eventually mutate so that it becomes easily human transmissible, there is no evidence that this has yet happened.


The best drugs on the market at the moment to treat people with H5N1 infection are Tamiflu (oseltamivir) and Relenza (zanamivir). Both drugs were originally made for use with patients who have other forms of human flu. Various countries have been stockpiling these drugs in case H5N1 does mutate and a pandemic ensues.


Chink found in flu virus enzymes

Skehel et al

Nature doi:10.1038/news060814-9

-- Click Here To View Abstract Online

-- Click Here To See Illustration of Cavity


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View drug information on Relenza; Tamiflu capsule.

Needle-Free Injection System Ideal For Pandemic Outbreaks - Medical International Technologies

Medical International Technologies Inc. (OTCBB:MDLH) Needle-Free Injection System, designed specifically to allow fast, accurate and safe injections, is rapidly moving toward establishing itself as a valuable instrument in the fight against disease in both humans and animals.


With its patented ability to adjust pressure and volume to meet varied conditions Med-Jet(human) and Agro-Jet(animal) puts the Company in a unique situation especially should there be a pandemic as predicted by many.


MIT has now received full certification granted under the International Organization for Standardization, as well as the Canadian Medical Device Conformity Assessment System, for devices to be licensed by HEALTH CANADA.


These certifications allow MIT to market the MedJet Needle-Free Injector for human use in all countries other than the U.S. The Med-Jet injector has been submitted for FDA approval, which, if accepted, will allow MIT to sell the Med-Jet in the United States.


The Company is working to complete two FDA filings. The first of these will be for use of the Med-Jet for injecting anesthesia in a variety of situations such as plastic surgery. The second, and most relevant in light of the news coming out of Asia and Europe concerning the spread of Influenza A (H5N1) to humans, will be the Med-Jet-H, for mass vaccination in case of a pandemic, such as Avian Influenza, Polio, Tuberculosis, Malaria.


With a rate of up to 800 injections per hour and its freedom from potentially deadly needlestick accidents, the virtually pain free, Needle-Free Injection System, provides an efficiency and level of safety that needlestick systems do not.


The Center for Disease Control (CDC: Link Here To Article) estimates that there are 600,000 to 800,000 needle stick injuries per year in the U.S. alone, that could be prevented with the use of a Needle Free Injector.


The Needle-Free Injection System also prevents the serious, often deadly medical problems that come from repeated use of the same needle in many 3 rd world countries.


MIT is also pursuing increasing interest in its Agro-Jet needle-free injector. Having the same benefits as Med-Jet, Agro-Jet could become a valuable instrument in the fight against Avian Flu via its ability to mass inoculate animals at over 1000 injections per hour without the risk of crosscontamination.


MIT has already shipped Needle-Free injectors to China and Turkey to help in the fight against the deadly H5N1 strain of bird flu virus. At present, the world's poultry industry commonly uses a needle/syringe to inoculate all birds that are at risk of infection.


The current method of inoculation requires that the needle be changed after a few hundred birds have been injected. This poses a major problem as cross contamination may occur and more importantly, it increases the risk of infecting the person performing the inoculation, with an accidental needle wound.


With the use of MIT's Needle-Free Injection System, we can safely inoculate poultry and other animals, throughout the world and help prevent the spread of bird flu, and other deadly diseases, to humans.
MEDICAL INTERNATIONAL TECHNOLOGY, INC.
mitcanada.ca

Health Protection Agency helps GPs recognise unusual symptoms of rare diseases

The Health Protection Agency, UK, has this week issued a set of clinical action cards to all GPs in England to help them recognise unusual symptoms that could potentially be linked to emerging diseases or other chemical, biological or radiological threats.


The New diseases, new threats resource illustrates the signs and symptoms that might arise from a range of diseases and threats, such as Sars or avian flu, which GPs may never have previously encountered.
Should GPs discover any of the symptoms illustrated, the resource urges them to contact their local health protection team for advice and support.


The resource has been developed by the HPA's emergency response division as part of a wider professional training programme. The programme has been given Ј2.6m in funding by the Department of Health, and includes resource production and scenario training.


Division director Dr Nigel Lightfoot said the cards, particularly, had been developed in response to requests by the medical profession for more specific training in the area of emerging diseases and threats.



'It is obvious that if, for example, there is a deliberate release, patients will present to GPs, A&E and walk-in centres first, so these clinicians need to be aware of the threats,' Dr Lightfoot said. 'We looked at how we could get a consistent message across to GPs throughout the country and we spoke to them and they all asked for simple messages which they could refer to quickly and easily. They suggested that this would be much better than a textbook or a CD-Rom.



'Our simple message is "be aware and, if you do have concerns about something suspicious, call the local health protection team". We are not asking doctors to do anything differently because we have always asked them to contact the HPA if they spot anything suspicious. But what we hope to do is raise their levels of awareness of these threats because what we have realised, particularly during the Sars issue, is that the sooner we know about a threat, the better chance we have of containing it.'



British Medical Association representative Dr Peter Holden said the resource would be a great asset to GPs. 'This is a very practical guide as it covers many things which GPs are unlikely to have seen, even if they have previously studied infectious diseases,' Dr Holden said.
'It is long overdue and the format is excellent - if it was a CD-Rom it would have been used as a coaster. I hope it becomes one in a series, because these are things that GPs need to know.'



A total of 37,500 cards have been sent to GPs across England, and a poster containing the same information is being developed for A&E staff. The devolved administrations have access to the cards but are currently developing ways to adapt the resource to better suit their health service structures. There has also been international interest in the cards.


by Shannon McKenzie


Public Health News

Indiana Health Officials Examine State's Pandemic Influenza Ethics Planning

Information relevant to Indiana's current pandemic influenza preparedness plan was presented July 16 during a symposium convened by the Indiana State Department of Health and the Indiana University Center for Bioethics, "The Ethics of Pandemic Influenza Planning in Indiana: What Have We Done and Where Are We Going?"


The purpose of the meeting was to involve local health officials, health care providers, and other stakeholders in a discussion on the ethical issues related to an influenza pandemic. The meeting began with an overview of Indiana's Pandemic Influenza Preparedness Plan by Deputy State Health Commissioner Mary Hill, RN, Esq. IU Center for Bioethics Director Eric Meslin, Ph.D., then spoke on "Incorporating Ethics into Planning: Indiana's Approach."


Speakers at the Indiana symposium also included Eleanor D. Kinney, J.D., MPH, the Samuel R. Rosen Professor of Law at the Indiana University School of Law, Indianapolis, and co-director of the Hall Center for Law and Health, and Margaret G. Gaffney, M.D., associate professor of clinical medicine at the IU School of Medicine and a faculty member at the IU Center for Bioethics. Some of the topics covered during the meeting were altered standards of patient care, patient triage, vaccination, and workforce management.



New data from a survey of public opinion regarding the ethics of pandemic influenza preparedness was also presented by James G. Wolf, M.A., director of the Survey Research Center at Indiana University-Purdue University Indianapolis. The purpose of the survey was to estimate public perception of priorities during an influenza pandemic, the likelihood of the public's compliance with public health recommendations, potential barriers to compliance, and what the public perceives as likely sources of assistance and information during an influenza pandemic.


Some highlights from the survey are:


-- Public generally supports state policies taking firm action in times of medical crisis;


-- Most would stay home if requested by state health officials;


-- There is a high likelihood of financial problems for 25-30 percent of those surveyed, especially for those with children, if in-home quarantine lasted 7-14 days;


-- People overwhelmingly report they would rely on family and friends for help; and


-- The public has far more trust in getting information about the pandemic from their doctor or health care provider than from more formal channels.


Today's meeting at the Indiana Government Center South followed a two-day national summit in Indianapolis on July 14-15, where state health officers and other senior public health officials from 35 states and U.S. territories convened to identify key ethical challenges, best practices and possible solutions during an influenza pandemic.
The key ethical challenges identified during the national summit included:


-- Meeting the obligation to engage communities in planning and response to ensure fairness, transparency and participation.


-- Identifying and defining criteria for allocation of scarce health care resources and critical infrastructure.


-- Defining criteria and mechanisms for implementing altered standards and places of care.


-- Preventing exacerbation of disparities in access to care.


-- Balancing the rights and duties of health care workers.


-- Providing palliative care.


-- Meeting the needs of at-risk populations.


-- Selecting effective community containment strategies.


-- Respecting cultural and religious practices in the face of mass fatalities.


For information on the national summit or pandemic influenza planning in Indiana, see bioethics.iu/pandemic_portal.asp.

France Confirms First H5N1 Infected Bird

A wild duck found dead 20 miles northeast of Lyon, in a wildlife reserve, had the H5N1 virus strain, said Ministry of Agriculture officials. All farmed poultry in France now have to stay indoors. Plans are underway to vaccinate all poultry in the country.


France is the largest producer of farmed poultry in the European Union. It is also common in France for country folk to have some poultry for personal consumption.


The speed at the which H5N1 virus has spread into Western Europe has taken many people by surprise. The sale of chicken meat for human consumption in some countries has virtually vanished. Italian shopkeepers say sales of chicken meat have dropped about 90%. Even though chicken meat is perfectly safe to eat, if cooked thoroughly, people are scared.


Now that bird flu has arrived to France, the UK looks on anxiously, hoping the 26 mile wide stretch of sea, which has protected the country so many times from foreign invasions, may do so again. If another cold snap hits Europe, the chances of wild birds travelling further west and landing in Great Britain grow. There are two routes migrating birds could take. Firstly, from Europe, to get away from the cold. Secondly, from Africa during the Spring when birds migrate. In West Africa bird flu is spreading fast.


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