The United States suffered a particularly harsh influenza season this year. Each year tens of thousands of people lose their lives to complications associated with influenza infection. Whether we’re facing seasonal influenza or a pandemic version of the virus, the threat to human health – and our nation’s health security – is real and serious.
Within ASPR, BARDA has acted swiftly to develop effective vaccines to prevent infections; diagnostics to identify infections; and antiviral drugs to treat those who become ill. BARDA has also enhanced the domestic influenza vaccine manufacturing capacity that is essential in a pandemic, in which the global demand for vaccine is likely to exceed supply.
Influenza viruses change continually—sometimes in small ways, necessitating updates to the annual influenza vaccines to protect against these “drifted” strains and imperiling the effectiveness of available antivirals due to the emergence of antiviral resistance, and sometimes in dramatic shifts, creating viruses to which humans are completely naïve.
Influenza is a true threat to health security that BARDA is committed to addressing. In the last decade BARDA’s strong partnerships have driven progress. Partnerships with over 190 biotechnology and pharmaceutical companies, U.S. government partners, and academic institutions have led to the development of 23 influenza vaccines, drugs, and diagnostics. Some of these products were used to respond to the 2009 H1N1 pandemic, stockpiled to enhance preparedness for influenza viruses with pandemic potential, like H5N1 and H7N9, influenza outbreaks or pandemics, and many of these products are now licensed, approved or cleared for use for seasonal influenza.
Developing the appropriate medical countermeasures is only the first step. With supplemental funding from Congress over the last decade, BARDA has invested heavily in increasing the domestic capacity for influenza vaccine production and diversifying the technologies used to make influenza vaccines. We have established the largest pre-pandemic influenza vaccine stockpile in the world, one that could vaccinate tens of millions should specific influenza viruses become a pandemic.
BARDA has made significant progress in partnering with cutting-edge companies to support better, faster, and more flexible vaccine technologies to keep pace with changes in the virus. For example, BARDA supported Seqirus in the development of the cell-based influenza vaccine, Flucevlax®, which is FDA licensed and available as a seasonal vaccine. We supported Protein Sciences Corporation, which was recently acquired by Sanofi Pasteur, to produce the recombinant vaccine, FluBlok®, also FDA licensed. BARDA is also supporting several adjuvanted vaccines to enhance the effectiveness of influenza vaccines and reduce the overall amount of the critical component of vaccine, antigen, needed in a dose as a way of stretching a limited supply to protect more people faster during a pandemic.
BARDA will continue to partner with companies to develop faster and more flexible diagnostics to provide early, actionable information such as in-home and wearable devices. Early information can empower patients to take action to seek earlier treatment (when medications are most effective) and to reduce transmission of the virus to others. BARDA is also seeking to improve respiratory protection, providing options that are comfortable, easy to use, and appropriate for all populations, including children. We are working with manufacturers to develop ventilators that are truly portable, low-cost, easy to use without specialized training, and flexible enough to be used for children and adults alike.
While BARDA’s public-private partnership model has resulted in significant progress, more must be done to decrease vaccine production time and increase efficiency and flexibility of an end-to-end response capacity. Domestic production capacity of cell-based and recombinant influenza vaccine needs to expand to meet anticipated pandemic demands. Additional clinical trials for cell-based and recombinant vaccines are needed in support of applications to expand their licensed indications for all age groups.
Lastly, we must continue to pursue novel antiviral drugs and other treatments to address the constant threat of antiviral resistant viruses, and to provide treatment options appropriate for the severely ill, a critical unmet need.
While influenza may be a fairly simple virus, combating it takes a multifaceted approach including early identification, prompt and effective treatment, and prevention through safe and effective vaccines.
If you are interested in learning more about BARDA, visit MedicalCountermeasures.gov. Also available for download is written testimony from the hearing “Examining U.S. Public Health Preparedness for Response Efforts to Seasonal Influenza” before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.
