The U.S. FDA has missed a key deadline to decide whether to grant full approval to Novavax's (NASDAQ:NVAX) COVID-19 vaccine.

The agency was apparently poised to give the green light, but regulators now want additional data, delaying approval, The Wall Street Journal reported. 

The development is significant as it comes just days after the FDA's vaccines chief, Peter Marks, announced his resignation. 

The newspaper noted that the agency had already notified HHS leadership that it was granting full approval, adding that draft communication to make public the decision were sent to HHS for review last week but has yet to be approved. 

The Journal added that Stefanie Spear, an aide with close ties to HHS Secretary Robert F. Kennedy, Jr., has had to approve all communications concerning vaccines. The secretary has a long history as a vaccines critic.

Rival COVID jabs from Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech received full approval in 2021. Full approval, as opposed to Emergency Use Authorization, means the shots can be used outside of a Public Health Emergency, such as the COVID pandemic, which ended in the U.S. in May 2023.

Although Novavax's EUA is still valid despite the end of the Public Health Emergency, the FDA can revoke it at any time.

Requests for comment sent to both Novavax and the FDA have yet to be returned to Seeking Alpha. 

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