Two innovative approaches to improve influenza vaccines will be sponsored by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) as part of an initiative to develop more effective and universal influenza vaccines and improve seasonal and pandemic influenza preparedness.
One project advances development of a novel oral influenza vaccine that can be administered as a pill and could generate broader types of immune responses compared to conventional influenza vaccines. The other project will 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 and may support seasonal influenza vaccine strain selection. Both projects will be coordinated and managed by ASPR's Biomedical Advanced Research and Development Authority (BARDA), as part of its influenza vaccine development program.
"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 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, California. Through this partnership, 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.
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.
BARDA also 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 – or forecasting how the influenza viruses may change over time. Influenza antigenic mapping could improve the vaccine's match to evolving H5N1 and 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.
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.
Building on Cambridge's earlier work supported by the U.S. 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.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To enhance and protect the health and well-being of all Americans, HHS provides effective health and human services, and fosters advances in medicine, public health, and social services.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov. Information about influenza is available at flu.gov.