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In a 21-0 vote with one abstention, Food and Drug Administration advisers recommended that the agency authorize Novavax’s two-dose COVID-19 vaccine.
In comments to the committee ahead of its vote, Dr. Peter Marks, the FDA’s top vaccine official, said: “We’re talking about making another option available for those who otherwise couldn’t get a vaccine. “
During the panel’s deliberations, Dr. Eric Rubin, editor of The New England Journal of Medicine, said the Novavax vaccine data closely resembles that of mRNA vaccines made by Moderna and Pfizer-BioNTech.
Under the same regulatory criteria, he said, “it’s not such a difficult decision now” to recommend clearance. Nevertheless, he said he was disappointed that there were not more data on the performance of the Novavax vaccine against current variants of the coronavirus. “We are looking at efficacy against strains that no longer exist,” he said.
An FDA summary found that the Novavax COVID vaccine was 90% effective in protecting people against mild, moderate, and severe disease. The main study used by the agency to assess the effectiveness of the Novavax vaccine included about 30,000 patients in the United States and Mexico. But data collection ended at the end of September 2021, months before omicron was detected in the United States.
The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct cells in the body to make the protein that triggers an immune response. Both approaches have been shown to be effective against COVID-19.
There is some evidence that the Novavax vaccine can cause rare swelling of the heart which also sometimes occurs in people who receive one of the other COVID-19 vaccines. The problem has also been observed with mRNA vaccines. But the committee concluded that the benefits of the Novavax vaccine outweigh the risks.
The FDA generally follows the recommendations of its advisers, but is not required to do so.
If the agency clears the Novavax vaccine, the final step before it can be rolled out would be approval by the Centers for Disease Control and Prevention.