Novavax's stock fell by 4.8% to $6.73 after the FDA requested an additional clinical trial to evaluate the effectiveness of its COVID-19 vaccine. The Wall Street Journal reported that the agency's request has delayed the vaccine's path to full approval in the U.S.
According to Reuters, the FDA has urged Novavax to provide more conclusive evidence regarding its vaccine's efficacy before it can receive final approval. The report also suggests that the approval process is being influenced by recent political appointees, potentially affecting the speed of the decision-making process.
Novavax has yet to issue an official response to the FDA's request. The company is currently navigating regulatory challenges amid discussions about vaccine approval expectations. However, as of the report, there was no comment from Novavax on the specific details of the FDA's demands or the implications for their vaccine rollout plans.