FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

(CNN) — The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.

FDA Requests Additional Trial of Novavax NVX-CoV2601 Vaccine Prior to Approval

After delays in the review of the COVID-19 vaccine—which missed its April 1 review deadline—the agency has requested new data.

FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot

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