A joint effort by government and industry has begotten a nearly $1 billion cell-culture flu vaccine manufacturing facility. Novartis ($NVS) and the U.S. Department of Health and Human Services announced the readiness of the Holly Springs, NC, facility Tuesday.
The 6-building plant's purpose is to provide quick response to an influenza pandemic, according to an announcement. The plant is part of HHS pandemic and bioterror preparedness efforts stretching back to at least the 2009 H1N1 flu season, which the World Health Organization labeled a pandemic.
HHS Secretary Kathleen Sebelius began lobbying then for "a modernized countermeasure production process" that has "more robust manufacturing, better stockpiling, and more advanced distribution practices." She continued pressing into early this year with publication of the HHS 2010 National Vaccine Plan, which made the case for "surge manufacturing capacity compared with traditional vaccine pathways."
It appears Sebelius got what she wanted in Holly Springs. The plant will produce cell-based flu vaccines that could be authorized by the FDA for emergency use during a pandemic, the statement said. It's been designated pandemic-ready. Cell culture-based production is "better controlled and can be scaled up more quickly" than traditional egg-based vaccine production.
Some question the concept of public/private drug ventures, harking back to 2006 when Project BioShield funded fledgling biotech VaxGen to develop an anthrax vaccine. The development effort stalled, VaxGen missed a milestone date, the government canceled a 75 million-dose order, and VaxGen folded.