Investing.com -- Novavax (NASDAQ: NVAX ) stock experienced a 2.4% decline Wednesday following a Wall Street Journal report that the U.S. Food and Drug Administration (FDA) has not met its deadline to decide on granting full approval for the company’s Covid-19 vaccine. This development comes shortly after the FDA’s top vaccine official, Peter Marks, was ousted.

The FDA had previously set an April 1 deadline to transition Novavax’s Covid-19 vaccine from emergency use authorization to full approval. However, the decision has been postponed, with senior FDA leaders indicating that the application requires additional data and suggesting that approval is not imminent, according to The Wall Street Journal, citing sources close to the situation.

Novavax’s vaccine has been available under emergency use authorization, a status that has facilitated its distribution during the pandemic. Full approval from the FDA would have affirmed the vaccine’s ongoing use even after the public health emergency concludes. This regulatory milestone has already been achieved by competitors Pfizer-BioNTech and Moderna (NASDAQ: MRNA ), whose Covid-19 vaccines received full FDA approval in 2021.

The delay in approval is a setback for Novavax, as the company had anticipated a positive outcome based on the FDA’s initial deadline. The FDA’s decision to require more data before proceeding with full approval has not only impacted Novavax’s stock performance but also the company’s plans for its Covid-19 vaccine in the post-pandemic market.

As the situation unfolds, Novavax will likely need to provide the additional data requested by the FDA to move forward with obtaining full approval for its Covid-19 vaccine. The company has not yet publicly commented on the FDA’s decision or provided a timeline for submitting the required information.

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