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Latest From BioNTech US
Pfizer is responsible for distribution work as part of its $1.95bn agreement with the US government for its COVID-19 vaccine. The CDC and Defense Department will lead a joint vaccination effort, senior adminsitration officals said, raising concerns of public health experts who say DOD support will be useful for the unprecented vaccination campaign, but public health leadership will be critical for public buy-in.
Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.
Supply agreement with the Health and Human Services Department and the Department of Defense reflects a profitable per dose price of $19.50 for an initial batch of 100 million doses of the vaccine candidate, pending FDA authorization or approval.
The International Coalition of Medicines Regulatory Authorities have sketched out the criteria that should be met before candidate coronavirus vaccines can proceed into late-stage trials, and agreed on how to design the studies and who should be included.
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