Novavax Must Conduct Additional Study for COVID-19 Vaccine Approval: FDA

The US FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine before considering approval. This is a major setback for the biotech as the study will be costly. The FDA's decision comes as a surprise, as Novavax's vaccine had previously shown promising results in clinical trials. The company's stock price has fallen as a result of the FDA's request.

The U.S. Food and Drug Administration (FDA) has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine before considering full approval. This request comes as a significant setback for the biotech company, as the study is expected to be costly and time-consuming. The FDA's decision is a surprise, given that Novavax's vaccine had previously shown promising results in clinical trials [1].

Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision due to the need for more data. The company's stock price has fallen as a result of the FDA's request, with shares declining by 6% on Friday, April 25 [2].

In a statement, Novavax confirmed that it has responded to the FDA's Post Marketing Commitment (PMC) request and is awaiting feedback from the agency. The company stated that PMCs are not unusual for many approved drugs and biologics and that it continues to believe its application is approvable. The FDA's request for a PMC and the subsequent delay in approval are part of the agency's ongoing efforts to ensure that products are safe and grounded in gold-standard science [1].

The Novavax COVID-19 vaccine, which uses more traditional protein-based technology, has been subject to emergency use authorization since 2022. Full FDA approval would provide additional reassurance to people seeking the shot and could potentially boost the company's market position. However, the additional study required by the FDA could delay this process and impact Novavax's financial performance.

The FDA's decision comes at a time of ongoing debate about the safety and efficacy of COVID-19 vaccines. The resignation of Dr. Peter Marks, the former director of the Center for Biologics Evaluation and Research, has added to the controversy, as he cited concerns about efforts being advanced by some on the adverse health effects of vaccination [1].

References:
[1] https://www.cnn.com/2025/04/25/health/novavax-covid-vaccine-trial/index.html
[2] https://www.marketwatch.com/story/novavax-slips-after-wsj-report-on-fda-request-for-another-vaccine-study-7b55f5e5