Novavax Vaccine Approval From FDA In Limbo, Says Report – But Retail Is Hopeful

Shares of Novavax were in the spotlight on Wednesday following reports that the company’s Covid-19 vaccine is unlikely to be approved soon.

The Wall Street Journal reported on Wednesday that the U.S. Food and Drug Administration (FDA) has missed the April 1 deadline for making a decision on the company’s COVID-19 vaccine.

Though the FDA was set to give full approval to the vaccine, senior leaders at the agency have now said that the company’s application needs more data and is unlikely to be approved soon, the report stated, citing people familiar with the matter.

The vaccination was previously cleared for emergency use. The FDA had set April 1 as the deadline to decide whether to grant it a normal, full approval, allowing for its continued use, like the Covid-19 shots from Pfizer and Moderna.  

However, sources told The WSJ that Novavax’s application is still pending and can be approved at any time.  

The report comes on the heels of the exit of FDA’s top vaccine official Peter Marks. As per The WSJ, Marks, whose resignation takes effect on April 5, criticized Health and Human Services Secretary Robert F. Kennedy, Jr.’s views on vaccines in his resignation letter.

The FDA is a federal agency of the Department of Health and Human Services.

On Stocktwits, retail sentiment about Novavax rose to the ‘bullish’ territory (55/100), coupled with a slight surge in message volume over the past 24 hours.

NVAX's Sentiment Meter and Message Volume as of 2:20 p.m. ET on April 2, 2025 | Source: Stocktwits

A Stocktwits user expressed optimism regarding the vaccine’s approval.

Another opined that the stock price seems to be in a holding pattern pending further news.

NVAX shares are down over 25% this year but up by over 35% over the past 12 months.

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