Novavax says ‘no official response’ from FDA on BLA status for COVID shot

In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for our COVID-19 vaccine included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We have not yet received an official response from the U.S. FDA regarding the status of our BLA.” Of note, shares of Novavax were under pressure on Thursday following Robert F. Kennedy Jr.’s comments on the company’s COVID shot approval delay. The Secretary of Health and Human Services pointed to the vaccine’s single-antigen composition — which he said has never worked against respiratory diseases — as the reason for the push back, adding that the FDA is “shifting our priorities to multiple-antigen vaccines.”