With 210 votes in one withdrawal, Food and Drug Administration advisors recommended that the agency approve the Novavax double-dose COVID 19 vaccine.
In a comment to the committee before the vote, Dr. “We’re talking about offering another option to people who may not be vaccinated otherwise,” said Peter Marks, FDA’s Chief Vaccine Officer. Eric Rubin, Editor-in-Chief of the New England Journal of Medicine, said the Novavax vaccine data is very similar to the Moderna and PfizerBioNTech mRNA vaccine data.
Using the same regulatory standards, he said “it’s not a very difficult decision so far” to recommend approval.
Nonetheless, he said he was disappointed that there was no more data on how the Novavax vaccine works against current variants of the coronavirus. “We are studying efficacy against strains that no longer exist,” he said.
According to the FDA summary, the Novavax COVID vaccine was 90% effective in protecting people from mild, moderate, and severe illnesses.
The main study used by the agency to evaluate the efficacy of the Novavax vaccine enrolled approximately 30,000 patients in the United States and Mexico.
However, data collection ended in late September 2021, a few months before Omicron was discovered in the United States.
