By Liz Essley Whyte

Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration's vaccine chief was pushed out.

The agency was set to give full approval to Novavax's shot, but senior leaders at the agency are now sitting on the decision and have said the Novavax application needed more data and was unlikely to be approved soon, people familiar with the matter said.

The FDA has allowed emergency use of Novavax's Covid-19 vaccine. It set an April 1 deadline for a decision on whether to grant a normal, full approval, the people said.

The decision would have cleared the vaccine's continuing use though the pandemic emergency has passed. The FDA gave full approval to Covid-19 shots from Pfizer and its partner BioNTech and from Moderna in 2021 and 2022, respectively.

Novavax said it is "continuing to communicate with the FDA and dialogue to ensure they have all the information required to complete our" application.

A Health and Human Services Department spokesman declined to comment. The FDA didn't immediately respond to requests for comment.

The federal government's stance on vaccines has been closely watched since vaccine skeptic Robert F. Kennedy Jr. took the helm at Health and Human Services, which oversees the FDA. In his confirmation hearings to be HHS secretary , Kennedy promised Sen. Bill Cassidy (R., La.) that he wouldn't change vaccine-approval systems.

The FDA already had sent communications about the decision to grant full approval for Novavax's Covid-19 shot to leaders in HHS. The decision also was on a forecast of coming actions for FDA leaders in the agency commissioner's office.

It would have been the FDA's first major vaccine move since Dr. Peter Marks, head of the division that reviews vaccine applications and a key architect of Operation Warp Speed during the first Trump administration, submitted his resignation Friday.

His departure sent down shares of biotech companies and vaccine makers, including Novavax, with analysts and investors questioning whether the FDA would keep approving scientifically-proven products.

HHS has in recent weeks been requiring the agency to clear all communications through the department, people familiar with the matter said. Stefanie Spear, a longtime close aide to Kennedy, has had to sign off on all vaccine-related communications, one of the people said.

In anticipation of approval, draft communications to announce the decision were sent to HHS for review last week but haven't been approved, a different person familiar with the matter said.

Novavax's shot uses an older protein technology and had been popular with people who preferred to avoid the messenger RNA technology used in the Pfizer-BioNTech and Moderna immunizations.

Novavax's request for full approval is still a pending application and can be approved by FDA at any time, people familiar with the matter said.

People can keep taking Novavax's vaccine under its emergency-use authorization. In 2021, Kennedy petitioned the FDA to revoke emergency use authorizations of Covid-19 vaccines. Now that he is health secretary, he could move to cancel Novavax's emergency authorization, as well as emergency authorizations that remain in place for the Covid-19 vaccines for children, health-policy experts said.

Write to Liz Essley Whyte at liz.whyte@wsj.com

(END) Dow Jones Newswires

April 02, 2025 13:20 ET (17:20 GMT)

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