Advisers to the FDA back Novavax COVID vaccine

By Scott Hensley,

Rob Stein

Published June 7, 2022 at 3:21 PM CDT

Dr. Stephaun Wallace, who leads the global external relations strategies for the COVID-19 Prevention Network at the Fred Hutchinson Cancer Research Center in Seattle, receives his second injection from Dr. Tia Babu during the Novavax vaccine phase 3 clinical trial in February 2021.

In a 21-0 vote with one abstention, advisers to the Food and Drug Administration recommended that the agency authorize Novavax's two-dose vaccine against COVID-19.

In comments to the committee before its vote, Dr. Peter Marks, the FDA's top vaccine official said, "We speak to making available another option for those who might not otherwise take a vaccine."

During the panel's deliberations, Dr. Eric Rubin, editor in chief of The New England Journal of Medicine, said that data for the Novavax vaccine look a lot like those for the mRNA vaccines made by Moderna and Pfizer-BioNTech.

By the same regulatory criteria, he said, "it's not that difficult a decision now" to recommend authorization. Nonetheless, he said he was disappointed that there wasn't more data about how the Novavax vaccine performed against current variants of the coronavirus. "We're looking at efficacy against strains that don't exist any longer," he said.

An FDA summary found the Novavax COVID vaccine had 90% efficacy in protecting people against mild, moderate and severe disease. The main study that the agency used to evaluate the Novavax vaccine's efficacy included about 30,000 patients in the U.S and Mexico. But data collection ended in late September 2021, months before omicron was detected in the U.S.

The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct the body's cells to make the protein that prompts an immune response. Both approaches have proved succesful against COVID-19.

There is some evidence the Novavax vaccine may cause a rare swelling of the heart that also occurs sometimes in people who get one of the other COVID-19 vaccines. The problem has also been seen with mRNA vaccines. But the committee concluded that the benefits of the Novavax vaccine outweigh the risks.

The FDA typically follows the recommendations of its advisers but isn't bound to do so.

If the agency authorizes the Novavax vaccine, the final step before it could be rolled out would be an endorsement by the Centers for Disease Control and Prevention.