US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

The U.S. Food and Drug Administration (FDA) has requested that Novavax NVAX conduct an additional clinical trial on its COVID-19 vaccine, according to a report by the Wall Street Journal [1]. The request comes after the FDA missed its April 1 deadline to approve the shot, which has raised concerns about its prospects.

The FDA's request for new data gives Novavax room to negotiate for a smaller, less expensive study, potentially costing only a few million dollars [1]. The vaccine maker has responded to the FDA's Post Marketing Commitment (PMC) request and is awaiting feedback from the agency. Novavax believes its Biologics License Application is approvable and looks forward to moving to full approval as soon as possible [1].

Shares of Novavax fell nearly 6% to close at $6.67 on Friday, following the WSJ report [1]. The stock was down more than 1% in after-market trade. However, shares rose 20% on Wednesday after the company said in a securities filing that it believed its Biologics License Application is approvable based on conversations with the FDA [2].

The request for additional clinical trials is part of a broader review process that has been affected by changes in the FDA's leadership under Health and Human Services Secretary Robert F. Kennedy Jr. [1]. The company wants to convert its emergency authorization into full approval to allow for expanded use and to better compete against messenger RNA vaccines from rivals such as Moderna and Pfizer [1].

Novavax's protein-based technology offers an alternative to the mRNA vaccines, which received full approvals in 2021 and 2022, respectively. The company's vaccine has been approved for emergency use but faces challenges in gaining full approval [1].

References:
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3R31UC:0-us-fda-asks-novavax-to-complete-new-clinical-trial-for-delayed-covid-19-shot-wsj-reports/
[2] https://www.marketwatch.com/story/novavax-slips-after-wsj-report-on-fda-request-for-another-vaccine-study-7b55f5e5