The U.S. Department of Health and Human Services (HHS) has taken historic steps to support the nation’s pandemic preparedness efforts by awarding three-year contracts to five U.S.-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential.
The contracts will be overseen by the Biomedical Advanced Research and Development Authority (BARDA) and are awarded to Sanofi Pasteur of Swiftwater, Pa., Novartis in Cambridge, Mass. and Holly Springs, N.C., GlaxoSmithKline of Philadelphia, Pa., Commonwealth Serum Laboratories of Melbourne, Australia, with Merck of West Point, Pa., and MedImmune of Gaithersburg, Md.
The effort allows HHS to purchase cell-based vaccine in addition to conventional egg-based vaccine. Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic, or developed rapidly in response to an epidemic. This option may assist HHS in providing more pandemic influenza vaccine sooner.
The contracts also support clinical trials and stockpiling of vaccine and adjuvants, enabling HHS to respond quickly to flu outbreaks and pandemics. Although current licensed seasonal flu vaccines do not contain adjuvants, clinical trials using adjuvants is an important part of pandemic preparedness, according to HHS. Adjuvants can be added to influenza vaccine to lower the amount of the active ingredient needed for the vaccine to produce an immune system response. Adding adjuvant results in more doses of vaccine being available during a pandemic.
Initially HHS will commit a total of $4.4 million for the companies to produce master vaccine seed stocks and $7.3 million for the companies to store pre-pandemic vaccines.
“These contracts build on the lessons learned from the 2009 H1N1 pandemic and nearly a decade of stockpiling avian flu vaccines,” stated BARDA Director Robin Robinson, Ph.D. “The increased national manufacturing capacity for pandemic influenza vaccines afforded by this effort is derived from successful public-private partnerships resulting in more U.S.-based vaccine manufacturing facilities and innovative vaccine technologies.”
The award was made under Solicitation Number: 11-100-SOL-00020.