Novavax COVID-19 Vaccine Awaits FDA Review of Manufacturing Data

On Tuesday, outside experts at the US Food and Drug Administration (FDA) voted 21 – 0 to give emergency approval to Novavax’s COVID-19 vaccine. Unlike every other approved COVID-19 vaccine, however, the company’s vaccine has yet to be formally approved by the agency two days later. The other vaccines, in contrast, were approved within 24 hours of outside experts giving the nod to approve.

According to the FDA, “On June 3, 2022, Novavax submitted an amendment with updated manufacturing and product information for the EUA to the FDA for review. FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use. The decision to grant an EUA will also take into consideration the discussion of clinical data and voting outcome of the June 7, 2022 VRBPAC meeting”

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(Source: Endpoints News, June 9^th, 2022)