FDA panel gives nod to Novavax COVID-19 shot

BY NATHANIEL WEIXEL – 06/07/22

An outside advisory panel voted overwhelmingly to recommend that the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, a move that could lead to the addition of a fourth vaccine to the U.S. arsenal.

The FDA’s vaccine advisory panel voted 21-0, with one abstention. The FDA does not have to follow the panel’s recommendation, though it often does.

Novavax’s two-dose vaccine was about 90 percent effective at preventing mild, moderate and severe COVID-19 during clinical trials. But, critically, the trials were conducted before the omicron variant, and panel members expressed concern about whether the efficacy would hold up against the current variants.

Novavax’s vaccine could appeal to people who have been reluctant to receive one of the mRNA vaccines, as the protein-based shot was manufactured using a fundamentally different process.

“We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do,” said Peter Marks, the FDA’s top vaccine regulator.

But winning over even a small number of eligible people who haven’t yet been vaccinated could be a difficult task, and it’s not clear how much success the company will have. The U.S. is not short on doses from any of the Pfizer-BioNTech or Moderna vaccines that have been available for more than a year.

Advisory committee member Arthur Reingold, chairman of the division of epidemiology at the University of California, Berkeley School of Public Health, said he was not convinced there will be many previously vaccine-hesitant people lining up for the Novavax shot.

“I’m a little skeptical about how many vaccine-hesitant are just waiting for this vaccine and are going to be convinced this is better for them than the vaccines available,” Reingold said. “On a population level I’m hoping to be proven wrong, but count me as skeptical about that.”

The Maryland-based Novavax secured a $1.8 billion contract from the Trump administration’s Operation Warp Speed early in the pandemic to scale up research and purchase up to 100 million doses. Yet it’s unclear when doses will become available and how many there will be.

Novavax executives have said negotiations are ongoing about how many doses the government will purchase from the initial agreement. In addition, the FDA is still conducting a review of the company’s manufacturing process.

Prior to the pandemic, Novavax had never brought a drug to market and did not own any production plants. The vaccine is currently being manufactured by the Serum Institute of India.

Novavax is banking on being able to use its shot as a booster. John Trizzino, Novavax’s chief commercial officer, told The Hill the company has data showing it can boost the immune response in people who received an mRNA shot initially, but the FDA is initially considering it only as a primary dose.

If the FDA gives the green light, the company plans to seek authorization as a booster in adults as well as in adolescents and children.

Source: thehill.com/policy/healthcare/3514939-fda-panel-gives-nod-to-novavax-covid-19-shot/?email=c9ee9b48a4fd5137d74376356d4fbee4667362d4&emaila=5bdbe7016203d76da678cbe799470fb3&emailb=9627226a37016e8172c23d758b3a3208763a3c68434246a0e8f44646d5f73076&utm_source=Sailthru&utm_medium=email&utm_campaign=06.07.22%20JB%20Novavax&utm_term=Breaking%20News