The US Food and Drug Administration was supposed to make a final decision about whether or not to approve Novavax's (NVAX) COVID-19 vaccine this week, but that deadline has passed with no clarity on when the decision will move forward again.

The vaccine remains available under the emergency use authorization (EUA) it received during the pandemic.

But the delayed decision and missed deadline, first reported by the Wall Street Journal, could signal further pain ahead for the pharmaceutical and biotech sectors, especially vaccine companies: a fear that has been mounting in the wake of mass layoffs at the health agencies this week.

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Some of the senior officials laid off were involved in the review of Novavax's vaccine. But reports that vaccine decisions are being overseen by a close aide to Secretary of the Department of Health and Human Services Robert F. Kennedy Jr., and that the deputy commissioner at the FDA intervened in the Novavax decision, are fueling concerns about the anti-vaccine beliefs of RFK Jr. and the potential impact to the industry.

"While the magnitude of the effect of the layoffs could take time to materialize in our view, the first example of action by the new administration was a pause on the review of Novavax's pending BLA review for its COVID-19 vaccine Nuvaxovid," wrote Bank of America Securities analysts in a note to clients Thursday.

"The delayed regulatory review, while potentially an isolated event, confirms one of the biggest near-term risks for the industry flagged to us by investors," they wrote.

The delay could also jeopardize a $125 million payout Novavax was expecting from Sanofi (SNY), its chosen partner to commercialize the shots for the upcoming flu season later this year, which is contingent on the approval. But Sanofi can still go ahead with the vaccine rollout on the basis of the EUA. 

Novavax's stock was down more than 7% early Thursday, and more than 20% in the past week. It pared back its losses by about 3% by midday Thursday.

Novavax said in a statement that it can confirm the delay in decision and that as of Tuesday, "we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval. As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA."

Novavax represents an alternative to the previously approved mRNA vaccines from Pfizer/BioNTech (PFE/BNTX) and Moderna (MRNA). Johnson & Johnson (JNJ) previously had an authorized non-mRNA vaccine, but reports of blood clots pulled it off the market during the pandemic.

Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee on social media platforms X, LinkedIn, and Bluesky @AnjKhem.

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