How a massive operation of medical countermeasures was mobilized to tackle the ever-present threat of influenza in the US and overseas.
At the 12th Annual World Vaccine Conference in Lyon, France, Robert Huebner, Deputy Director, Influenza and Emerging Diseases Division, BARDA (Biomedical Advanced Research and Development Authority) of the US Department of Health & Human Services revealed to delegates attending the conference how a massive operation moved into top gear with medical countermeasures, triggered by the outbreak of a highly infectious H1N1 influenza strain (swine flu) that apparently originated last year in Mexico. Several weeks had elapsed before cases of the H1N1 variant appeared in the US and kick-started the US 2009-H1N1 Vaccine Strategy.
BARDA's mission is to take products in R&D that look promising and move them forward to make them available commercially. BARDA’s specific product areas of interest include pandemic influenza vaccines, emerging infectious diseases products, and CBRN (chemical, biological, radiological and nuclear) agents. BARDA's portfolio approach to advanced development of products enables stockpiling of key products and infrastructure building as necessary.
Within the Pandemic Influenza Vaccines Division (PIVD) of BARDA is a program for cell-based influenza vaccine, recombinant vaccine and an energy-sparing technology that can be used in conjunction with influenza vaccines.
Huebner outlined PVID’s strategy in response to the H1N1 outbreak in 2009. Stockpiles of H1N1 and H5N1 vaccines have been procured for use in the event of influenza outbreaks. For infrastructure building, one PIVD goal is to re-establish domestic capacity for influenza vaccine production in the US whilst supporting typical "bricks and mortar" type programs (like building the Novartis facility for cell-based vaccines at Holly Springs, NC).
PIVD also has a single anti-viral program for an IV drug, Peramivir, and develops strategic, Federal stockpiles of antiviral drugs, run from the Center for Disease Control (CDC). Also covered by PIVD are diagnostics and respiratory devices (eg, stockpiling of respiratory protection devices and development of next generation respirators that would be of lower cost and easier to use because medical equipment and supplies or ventilators that could be in short supply in the event of a pandemic outbreak).
The US H1N1 vaccines were supplied by five manufacturers and ancillary products from four manufacturers. They were shipped to a central distributor (McKesson) for onward distribution to 120,000 points of distribution (PODs) and then received by 300 million US children, healthcare workers, children caregivers, pregnant women, people with underlying chronic diseases and the general public.
Most of the influenza vaccines were purchased in multidose vials, but also in single-dose syringes (for pregnant women and children) including inactivated, subunit vaccines from GSK, Novartis, Sanofi Pasteur, and CSL; intranasal sprayers of live, attenuated vaccine were purchased from Medimmune.
Huebner said there are many lessons remaining to be learned for the next phase in the fight against influenza, and the challenge remains to forecast and translate early warnings into fast and efficient vaccine manufacturing.