FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review

 Despite the FDA missing its deadline to decide on a potential approval for Novavax’s COVID-19 vaccine at the start of the month, the company remains confident that its protein-based shot is worthy of a traditional green light.

Now, however, Novavax says the FDA has been in contact, but is asking the company to commit to generating additional post-marketing data on the vaccine, should it gain approval. 

As it stands, Novavax’s COVID-19 shot—which uses a more traditional protein-based platform compared to Pfizer-BioNTech’s and Moderna’s mRNA vaccines—is available in the U.S. under an emergency use authorization (EUA), which is a more limited form of use than a full approval. 

In a Wednesday press release, Novavax said it looks forward to working with the FDA on the matter and hopes to “expeditiously” address the new data request in a bid to “move to approval as soon as possible.”

The FDA was expected to grant Novavax’s COVID shot a full, traditional approval on April 1, as other COVID vaccines have been over the past few years after their initial EUAs, though that date came and went with little clarity from the agency on exactly why it had missed its decision deadline.

Novavax believes its vaccine was approvable then and still is today, based on discussions with the U.S. regulator, the company stressed in its release this week.

The FDA’s failure to meet its decision deadline at the start of the month has compounded concerns about the effect of mass Health and Human Services layoffs on the ability of the regulator to carry out its core duties. At the same time, fears that HHS Secretary Robert F. Kennedy Jr. is spearheading an anti-vaccine agenda from within the country’s federal health apparatus are mounting.

While Novavax’s shot looked slated for a thumbs up earlier this month, senior FDA leaders allegedly changed their tune after determining they needed more data on the vaccine, The Wall Street Journal reported at the time.

Politico separately reported that the FDA’s principal deputy commissioner, Sara Brenner, M.D.—who was tapped to lead the agency as acting commissioner shortly after President Donald Trump’s inauguration—was the one to intervene in the approval process. The move would have been highly unorthodox, given that political appointees at the FDA typically follow the advice of career staff to avoid partisan bias, Politico pointed out.

Meanwhile, COVID vaccines in general may face additional pressures in the U.S. after a long-delayed meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) last week hinted that restrictions on coronavirus boosters could be coming down the pike.

In the committee’s first meeting under HHS Secretary RFK Jr., the panel appeared poised to recommend reduced use of vaccines for both COVID-19 and human papillomavirus (HPV), the latter of which can, in some cases, cause cancer in those infected with certain types of the virus. 

On COVID shots specifically, the advisers seem eager to narrow their recommendations for booster doses to incorporate a risk-based approach versus a universal one, analysts from Leerink Partners and Citi wrote in separate investor notes in early April.

A shift away from a universal COVID shot recommendation could pressure sales from Pfizer, BioNTech and Moderna both this year and next, the Leerink team said. The issue will likely extend to Novavax, too, if the company scores a traditional approval for its shot.

ACIP is scheduled to vote on both COVID and HPV recommendations in late June.

Elsewhere, agency insiders have been sounding the alarm about the FDA’s diminished ability to operate following thousands of staff cuts and multiple high-profile departures at the regulator since the second Trump administration’s arrival in office this year.

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and Research (CBER)—who resigned in March—warned that the mass downsizing at the agency could hamstring the regulator’s ability to review drugs beginning in 2026 or 2027.

While staffers who were spared by the layoffs remain committed to meeting the FDA’s established drug review timelines, meddling in the process by political appointees at the agency could lead to delays, increased evidence benchmarks for approvals and, ultimately, a greater number of rejections, the former director warned.

The BMO team never outright identified the expert it interviewed, though signs point to it likely being Peter Marks, M.D., Ph.D., who announced his departure as head of the CBER in late March. CBER oversees the evaluation of vaccines, blood products, and certain biologics in the U.S., including cell and gene therapies.

https://www.fiercepharma.com/pharma/fda-calls-post-marketing-data-novavax-continues-anticipate-full-approval-covid-vaccine