Real-World Evidence On COVID 19 Vaccines Coming Into US FDA
Peter Marks says agency is getting first RWE readouts of vaccine safety; AstraZeneca’s vaccine has no expiration date, so stockpile is not currently at risk of being thrown out, the CBER director tells a House hearing.
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Member states do not have to follow European Medicines Agency guidance – which means division and confusion could persist after it issues its verdict on the safety of the AstraZeneca vaccine.
US is keeping a ‘small inventory’ of AstraZeneca’s vaccine so people in the US can receive it immediately following authorization, White House official says. President Biden seeks to boost vaccine manufacturing in India in parntership with India, Japan, and Australia.
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.