Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 shot.
Novavax was expecting to hear back from the FDA about a full, traditional approval for its protein-based COVID-19 vaccine by April 1. Instead, senior leaders at the FDA have decided they need more data on the shot, The Wall Street Journal first reported, citing people close to the matter.
When reached for comment, Novavax’s media team directed Fierce Pharma to a company statement confirming that the FDA had missed its decision deadline. As of Tuesday, the company “had responded to all of the FDA’s information requests” and felt its application was ready for approval, according to the statement.
“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,” the company said Wednesday.
Novavax’s vaccine currently boasts an emergency use authorization in the U.S. and will still be available under that framework, at least for now. Still, a full approval—such as those granted to Pfizer and Moderna’s mRNA-based COVID vaccines in 2021 and 2022, respectively—would allow Novavax’s shot to stick around long-term in the endemic vaccine market.
Novavax also needs that full approval to secure a $175 million milestone payment from Sanofi, Politico reported this week. Last year, Sanofi struck a deal worth upward of $1.2 billion to partner with Novavax on co-commercialization of the company’s COVID-19 vaccine and to develop combination shots.
The FDA sets deadlines to make pharmaceutical approval decisions under to the Prescription Drug User Fee Act (PDUFA). Created by Congress in 1992, the PDUFA allows the FDA to collect fees from companies submitting drug applications for review.
User fees and “PDUFA dates,” as FDA decision deadlines are colloquially known, have played an important part in accelerating the agency’s review and approval process and help drugmakers hold the regulator accountable for delivering decisions in a timely manner.
Robert F. Kennedy Jr. has side-eyed user fee programs in the past over concerns of excessive industry influence.
Following a sweeping round of federal layoffs earlier this year—which hit the FDA but were separate from the 10,000 cuts more recently announced by the Department of Health and Human Services (HHS)—multiple Democratic lawmakers warned in a letter to RFK Jr. that the move could scupper user fee collection efforts.
“This would be seriously detrimental to our medical drug and device programs by slowing the premarket review process, stifling innovation and preventing patients from accessing potentially lifesaving products,” the lawmakers wrote in February.
While cuts have gutted myriad divisions of the FDA—and many of the fine details remain murky—Politico’s AgencyIQ reported this week that nearly the entire FDA team involved in negotiating industry user fees has been laid off.
The missed deadline comes amid a period of uncertainty for U.S. biopharma regulations, with vaccines seemingly at risk of interference from the second Trump administration.
Shortly after RFK Jr. assumed the captain’s chair at the HHS—which oversees the FDA—the department postponed multiple key vaccine advisory meetings. The HHS secretary further announced an investigation into the rise of chronic diseases in the U.S., stating that nothing will be “off limits,” including childhood vaccine schedules.
The situation then came to a head last week, when high-ranking FDA official Peter Marks, M.D., Ph.D.—who led the agency’s Center for Biologics Evaluation and Research in charge of vaccines and biologic drugs—abruptly resigned. In a scathing resignation letter, Marks singled out RFK Jr. for spreading “misinformation and lies” on the topic of vaccines.
Complicating the Novavax issue further, the FDA’s principal deputy commissioner, Sara Brenner, M.D., was the one to intervene in the approval process and call for more data, according to Politico, which cited comments from multiple people close to the situation.
Brenner, who had previously worked in the FDA’s Center for Devices and Radiological Health, was tapped to lead the agency as acting commissioner shortly after President Donald Trump’s inauguration on Jan. 20. Johns Hopkins surgeon Marty Makary, M.D., has since been confirmed as the agency’s full-time commissioner.
If accurate, the move would be highly unorthodox for the FDA. Typically, political FDA appointees follow the advice of career staff to help protect scientific integrity from partisan bias, Politico pointed out.