US COVID Vaccine Early Distribution Plans Assume Emergency Use Authorization First
CDC developing vaccine distribution plans with four states and one large city that will serve as a ‘foundation’ for other jurisdictions; plans include provisions for all potential vaccines, but logistics will vary depending on product, especially given the cold chain issues associated with mRNA vaccines from Pfizer and Moderna.
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Most vaccines will be distributed centrally by McKesson, but those with ultra-cold storage requirements will be shipped directly from the manufacturer to the vaccination site. Data exchange system will enable public and private databases to talk to each other and help ensure individuals receive timely revaccination with a second dose of the same vaccine regardless of location.
The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.
US FDA Commissioner Hahn’s controversial statement about approval before the end of Phase III has at least one taker, which may concern public health observers.