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Improving Influenza Vaccines the Subject of BARDA R&D Initiative

Improving Influenza Vaccines the Subject of BARDA R&D Initiative Homeland Security TodayTwo innovative multi-million dollar programs to improve influenza vaccines is being sponsored by the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The initiative is part of a broader effort to develop more effective and universal influenza vaccines, and to improve seasonal and pandemic influenza preparedness.

“Seasonal influenza contributes to tens of thousands of deaths every year in the United States and that number could reach hundreds of thousands during a pandemic or severe outbreak,” said Biomedical Advanced Research and Development Authority (BARDA) Director Robin Robinson, Ph.D. “Developing more effective and universal influenza vaccines is a vital element in our strategy to prepare the nation for a pandemic, as well as improving public health when seasonal influenza virus is circulating.”

BARDA will support the development of a room temperature stable, oral recombinant influenza vaccine under a two-year, $14 million contract with Vaxart Inc. of South San Francisco.

“Through this partnership,” the announcement stated, “Vaxart will conduct clinical studies to test the safety, ability to produce an immune system response, and efficacy of their experimental oral influenza vaccine in human volunteers as compared to a licensed inactivated influenza vaccine. In earlier clinical studies, this experimental oral vaccine indicated that it may elicit immune responses associated with protection against multiple seasonal influenza viruses and viruses with pandemic potential.”

One of the projects is aimed at advancing development of a novel oral influenza vaccine that can be administered as a pill, and which potentially could generate broader types of immune responses compared to conventional influenza vaccines.

The other project is designed to create a data-driven strategy to inform the process for selecting more effective influenza virus vaccines to be added to the national pre-pandemic influenza vaccine stockpile. It may also support seasonal influenza vaccine strain selection.

Both projects are being coordinated and managed by BARDA as part of its influenza vaccine development program.

ASPR said in its announcement that, “A more effective influenza vaccine that is orally administered could improve an emergency response to a pandemic in which millions of people would need to be vaccinated against a new influenza virus strain. Given orally, such a vaccine would not require trained personnel to administer, as is required currently for licensed influenza vaccines delivered by shots or nasal spray.”

Additionally, BARDA will provide $8 million — with an option for a total value of $24.3 million over five years — for the University of Cambridge in Cambridge, United Kingdom to develop methods of antigenic mapping – the forecasting how the influenza viruses may change over time.

For example, Influenza antigenic mapping could improve matching vaccines to the constantly mutating and highly lethal H5N1 bird flu virus, which virologists and public health preparedness authorities have long been worried will evolve into a highly virulent human transmissible strain.

Influenza antigenic mapping could improve matching vaccines could also improve “Other potential pandemic influenza viruses so that vaccines generate protective immune responses not only to currently circulating influenza viruses, but also to newly emerging ones. The H5N1 virus is found in birds, and occasionally is transmitted from birds to humans,” ASPR stated.

During the last major H5N1 scare, researchers, including from the Centers for Disease Control and Prevention and World Health Organization believe there were at least two instances in which the deadly H5N1 virus was transmitted between members of two families.

ASPR stated that, “Influenza viruses frequently change, creating challenges in producing a vaccine that stimulates broad, long-lasting immunity against influenza. Understanding how a virus can change will help vaccine developers produce vaccines that will be more effective.

Because of the rapidly mutating ability of influenza strains is what caused a shortage in appropriate flu vaccines last winter. The strains the vaccine was made for evolved before the vaccines were produced and distributed.

ASPR said, “building on Cambridge’s earlier work supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, Cambridge’s scientists will use the antigenic mapping approach to determine how effective each of these H5N1 vaccines are likely to be. The scientists also will demonstrate the utility of this predictive analytical method by preparing experimental vaccine candidates that are based on antigenic mapping results to inform the design and development of more effective than the currently licensed pandemic vaccines against a broad range of current and projected future H5N1 viruses. These results will be shared with NIAID for potential use in improving seasonal influenza vaccines.”

Both projects are part of BARDA’s comprehensive integrated portfolio approach for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools and non-pharmaceutical products for public health emergency threats. In addition to pandemic influenza, these threats include chemical, biological, radiological and nuclear agents, emerging infectious diseases, and antimicrobial resistance.

The impact of a biological attack on US soil could be catastrophic, resulting in a massive loss of life, severe economic consequences and chaos, Homeland Security Today reported last week. Consequently, the nation’s capacity to detect, respond to and mitigate the consequences of this potential threat must be a top national security priority. However, US biosurveillance capabilities face a number of serious challenges, according to a recent Government Accountability Office (GAO) audit report.

BARDA is also spending $5.5million for a base period of 16 months, and up to a total of $42.9 million over 10 years if all options are exercised, for the contract awarded to First Light Biosciences, Inc. of Bedford, Massachusetts to pursue development of an anthrax diagnostic test for use in a doctor’s office, hospital, clinic or field setting that will provide results within 20 minutes. The research could also have the ability to test for multi-drug resistant anthrax infections.

A novel skin substitute called the Biodegradable Temporizing Matrix, is also being developed under a three-year, $8.2 million contract with PolyNovo Limited of Port Melbourne, Australia.

The development is part of an effort by BARDA to develop new medical products to protect health and safety during chemical, radiological or nuclear emergencies, particularly those involving explosions. Some of these products also may find more common uses, such as among victims of fires.

Homeland Security Todayhttp://www.hstoday.us
The Government Technology & Services Coalition's Homeland Security Today (HSToday) is the premier news and information resource for the homeland security community, dedicated to elevating the discussions and insights that can support a safe and secure nation. A non-profit magazine and media platform, HSToday provides readers with the whole story, placing facts and comments in context to inform debate and drive realistic solutions to some of the nation’s most vexing security challenges.

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