One of three manufacturing sites commissioned by the Department of Health and Human Services (HHS) to quickly develop and produce flu vaccines in the case of a pandemic is expected to be fully operational by 2017, officials say.
Events like the anthrax attacks in 2001 and the H1N1 outbreak in 2009 have heightened concern in recent years regarding the ability of the U.S. to effectively prevent and thwart a pandemic or bioterror attack.
In an effort to prepare for such an event, the Biomedical Advanced Research and Development Authority (BARDA), a division of HHS, awarded nearly $440 million in contracts in fiscal 2012 and 2013 to establish three Centers for Innovation in Advanced Development and Manufacturing, led by Texas A&M University in collaboration with GlaxoSmithKline ($GSK), Novartis ($NVS) and Emergent BioSolutions ($EBS), to produce medical countermeasures, including flu vaccines, using flexible manufacturing methods.
Alternative manufacturing methods might include using disposable equipment like growing cell cultures in plastic bags rather than in stainless steel tanks, or using cell-based or recombinant technologies to make vaccine instead of traditional egg-based technology.
While a new report by the U.S. Government Accountability Office (GAO) says it's too soon to assess how effective the BARDA initiative will be, it says one of these three centers--the Novartis site--is on track to finish construction, acquire a flu pandemic vaccine candidate and validate its vaccine surge capacity with the FDA by 2016. Meanwhile, the Texas A&M University and Emergent centers are expected to be online by 2017 and 2020, respectively. BARDA reports that at least one of these centers will be able to manufacture pandemic flu vaccines starting in 2017, according to the GAO.
Once all three manufacturing centers are up and running, each will be able to produce 50 million doses of vaccine within four months of receiving a flu virus strain, and the first doses for the public would be available to HHS within 12 weeks, according to the GAO report.
BARDA officials say some of the selected sites may begin providing services to HHS--such as assisting medical countermeasure developers in manufacturing small amounts of products that can be used in clinical trials--as soon as this year.
- read the GAO report (PDF)