Australia-based vaccine maker CSL Biotherapies, which has had to deal with some quality issues raised by the FDA, has been selected by the U.S. government to further strengthen the country's supply of pre-pandemic and pandemic vaccine antigens in case of an influenza outbreak.
The contract between CSL and the U.S. Department of Health and Human Services (HHS) stipulates that CSL manufacture and store antigens that can be used against influenza strains with the potential of developing into a national scare. CSL will also be asked to develop virus "seeds" for other manufacturers, and to formulate, fill and finish bulk stored antigen, as needed by the U.S. government.
Given the wide scope of a possible pandemic, the contract is valued upward of $1.5 billion. The Australian speculates that about one-third of the contract's value will go toward pre-pandemic planning, with the remaining amount going toward pandemic demand, that is, if one actually materializes.
The agreement comes after CSL secured an FDA closeout letter last month, after two years of manufacturing issues tied to several children becoming ill from its flu vaccine. The regulator also took issue with dark particles found in some vials.
HHS in June awarded $400 million in contracts to Emergent BioSolutions ($EBS), GlaxoSmithKline ($GSK) and Novartis ($NVS) for the first phase of plans to have vaccines in case of an outbreak. It said those companies would put up the initial 35% in funding to build and expand manufacturing capabilities in the U.S. that would be dedicated to U.S. flu vaccine in case of an event.
- here's the press release
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