COVID-19 Vaccine Manufacturing: CBER Seeking Capacity Through Collaboration
While a vaccine candidate is still months away, US FDA is already working to identify manufacturing capacity, CBER’s Peter Marks says in an interview.
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Sanofi CEO Hudson tries to reassure France on access, but notes that Europe does not currently have a program to assure a supply of a coronavirus vaccine as soon as safety and efficacy have been established.
At Senate hearing, FDA and NIH officials say government and vaccine developers are outlining production needs with ability to shift manufacturing from their candidates to others to ensure production of the most promising products. FDA Commissioner Hahn says as an essential worker he would break quarantine if needed at a critical White House or other meeting.
As Pfizer begins human trials, CBER’s Marks eyes nine-month target for a vaccine and urges at-risk manufacturing once a candidate reaches Phase III.