Wait For Stability Results Before Moving Expiring COVID-19 Vaccine, Woodcock Says
Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.
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Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.
Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.
AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.