Novavax says vaccine application still ‘approvable,’ despite FDA delay

Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on a postmarketing clinical trial.

Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company.

A spokesperson for Novavax, contacted by BioPharma Dive Friday, said the company “cannot comment on the details of the request” while engaging with the FDA. It’s unclear when exactly the agency wants Novavax to complete the study.

Postmarketing commitments “by their nature are completed after BLA approval,” Novavax said in its Monday statement, referring to the Biologics License Application it submitted. “We believe our application is approvable upon alignment on the details of the PMC.”

Novavax’s vaccine, which has been available under an emergency use authorization since 2022, demonstrated 90% efficacy across more than 25,000 adults who participated in prior clinical testing run by the company. Unlike Pfizer’s and Moderna’s COVID shots, Novavax’s is built around an older, protein-based technology.

All three companies have, at the FDA’s request, annually updated the coronavirus strain their shots target to better match what’s circulating each year. These updates have not previously been treated by the FDA as constituting a new product, similar to how the agency regulates influenza vaccines.

In a Saturday post on the social media site X, FDA commissioner Martin Makary appeared to change that policy: “This is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies,” he wrote.

Asked to clarify Makary’s comments, Andrew Nixon, the Department of Health and Human Services’ director of communications, said in an email that “the urgency to rush approval of boosters without normal oversight no longer exists.”

“A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years,” he added.

The FDA previously agreed to review Novavax’s application and set a decision deadline of April 1, which it missed, reportedly after unusual intervention by the agency’s top leadership. Novavax would receive a $175 million milestone payment from partner Sanofi should it win full FDA approval of its shot. 

Vaccines have been under heightened scrutiny since the appointment of Robert F. Kennedy Jr. as HHS Secretary. A long-time critic of U.S. vaccination policies, Kennedy has come under criticism for his handling of the measles outbreak in West Texas. He has reportedly been considering changes to federal vaccine panels, two meetings of which have been disrupted since he was sworn in.

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