More study needed or vaccine pushback? FDA lags on ruling for Novavax's COVID-19 booster

Federal regulators need more data to evaluate the safety and efficacy of COVID-19 booster shots, said Food and Drug Administration (FDA) Commissioner Marty Makary, MD, MPH.

Approval status appears uncertain for at least one COVID-19 vaccine for use in fall 2025. Numerous national news outlets have been reporting on the back-and-forth between FDA and Novavax, one of the makers of injections against the virus that spurred the worldwide pandemic.

Novavax shots

Novavax's vaccine was approved under an emergency use authorization of August 2022, according to the Center for Infectious Disease Research & Policy (CIDRAP) at the University of Minnesota. The company obtained an emergency use authorization for its updated COVID-19 vaccine in August 2024. The U.S. Centers for Disease Control and Prevention issued standing orders for administering the vaccine for patients aged 12 and older. The Novavax shot is the only protein-based option to boost immunity against SARS-CoV-2, the virus that causes COVID-19, according to CIDRAP.

Novavax has applied for full licensing, with a scheduled decision date of April 1, according to CIDRAP and CBS News. Novavax confirmed that was the FDA’s Prescription Drug User Fee Act date for its Biologics License Application (BLA) seeking approval.

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval,” said Novavax’s official statement of April 2.

“Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19,” the company’s statement said. “We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.”

Why the delay?

April 1 came and went with no pronouncement from FDA. Since then, Novavax has issued periodic updates on its FDA application. On April 25, The Wall Street Journal reported “FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed COVID-19 Shot.” That test could cost Novavax “tens of millions of dollars,” and “be so prohibitively expensive the company might not be able to fulfill it.”

A day later, Makary said Novavax was trying to bring a new product to market with a study of a different product from 2021, according to his post on social media platform X, formerly Twitter.

“New products require new clinical studies,” his online post said. “Under this administration, we are prioritizing the Gold Standard of Science — not what saves pharma companies ‘tens of millions of dollars.’”

Novavax acknowledged “a formal communication” from FDA requesting a postmarketing commitment (PMC) for a clinical trial.

“PMCs by their nature are completed after BLA approval,” the company’s April 28 statement said. “PMCs are not unusual with many approved drugs and/or biologics having at least one PMC or requirement. We believe our application is approvable upon alignment on the details of the PMC. We look forward to continued engagement with the FDA.”

Time for trials

Apart from cost, timing also could be a factor, along with criteria for what constitutes a new product and tests needed for it. ABC News reported a new trial likely would not be possible before fall.

“I don’t think because there’s a strain change that this is a new product,” Jesse Goodman, MD, MPH, of Georgetown University, a former FDA vaccine chief, said in that report. If that’s the new policy, “you’d always be doing clinical trials and you’d never have a vaccine that was up to date.”

A financial shot in the arm — or not

Apart from human health, it appeared the U.S. vaccine rules and trials could have effects on the financial health of Novavax as a business. In May 2024, the company and global health care researcher Sanofi announced a co-exclusive licensing agreement to co-commercialize the protein-based non-mRNA adjuvanted COVID-19 vaccine and develop novel COVID-19-influenza combination vaccines. That deal provided Novavax with a cash and equity investment totaling $1.2 billion.

FDA and vaccines

Health care sector observers have wondered if the case is another signal about potential changes coming in rules about vaccine testing, reviews and approvals at FDA. U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. has voiced his skepticism about the safety and effectiveness of vaccines. The Novavax situation has developed in the weeks after the resignation of Peter Marks, MD, PhD, head of FDA’s Center for Biologics Evaluation and Research. Politico reported Makary agreed with efforts to force out Marks, who led COVID-19 vaccine research under the first administration of President Donald J. Trump.

In his letter of resignation, Marks said: “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.” CNN reported an HHS official countered that if Marks “does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.”