The Food and Drug Administration‘s panel of vaccine experts has voted overwhelmingly to authorize Novavax’s two-dose COVID-19 vaccine, paving the way for a new option that officials hope will attract unvaccinated people.
The Vaccines and Related Biological Products Advisory Committee voted 22-0 with one abstention in favor of authorizing the shots. The FDA will make the final decision, likely within the coming days.
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The discussion touched on the vaccine’s safety profile, its efficacy, and optimism among agency officials that the shots, which do not use the same mRNA technology as other vaccines, will attract holdouts.
“Anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
Unlike the Moderna and Pfizer-BioNTech vaccines, the Novavax vaccine relies on lab-engineered spike proteins to mimic the one on the coronavirus pathogen that binds to cells and infects people. The engineered spike protein is coupled with an adjuvant, in this case derived from a tree native to South America, which turbocharges the immune system to fight the real thing.
Members of the outside panel were concerned about the lack of data to show the Novavax vaccine’s efficacy against the omicron variant. Novavax, like Moderna, Pfizer-BioNTech, and Johnson & Johnson, developed its vaccine to protect best against the original strain of the coronavirus. It proved highly effective against the alpha, beta, and gamma variants, but further study is needed to measure its efficacy against omicron and its many offshoots.
Still, clinical trial evidence from Novavax reported that two doses induced an immune response against omicron, albeit lower than against the original strain. Adding a third dose of the vaccine boosted the immune response to omicron back to the level seen against the original strain after two doses.
“Overall, it’s factual that we don’t have efficacy data against omicron,” said Novavax Chief Medical Officer Dr. Filip Dubovsky. “But what we do have is a technology that we think generates a broad immune response demonstrated against a broad array of variants.”
The committee also discussed the relationship between the vaccine and four instances reported soon after the shots were administered of myocarditis and pericarditis, cardiac inflammatory conditions, in young men. Members raised the red flag of a possible link between the two, a link that was also found to exist between the cases of inflammation and the mRNA vaccines.
“We have some preliminary evidence from the clinical trials of this vaccine from Novavax that raises this concern, although I think we need more data from post-authorization use in larger numbers of individuals to really get at what the rate of myocarditis associated with this vaccine is,” said Dr. Doran Fink, the FDA’s deputy director-clinical in the Division of Vaccines and Related Products Applications.
Novavax’s chief safety officer, Dr. Denny Kim, meanwhile, said that the totality of evidence gleaned thus far “is not enough to establish an overall causal relationship with the vaccine.”
Although the VRBPAC’s recommendation is not binding, regulatory officers at the FDA typically follow it. Novavax would become the fourth vaccine to enter the U.S. market more than a year after the first shots became available. Nearly 77% of U.S. adults have been fully vaccinated to date, meaning the market for an additional vaccine is relatively small. But its more traditional design platform is expected to lure in holdouts who objected to the mRNA vaccines from Pfizer and Moderna.
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Novavax was one of the most promising early vaccine candidates in 2020 during the race to develop effective shots and treatments for the novel virus. The Trump administration poured $1.6 billion into the development of the Novavax vaccine, which has hit myriad stumbling blocks since then. For instance, the company had to build a manufacturing infrastructure essentially from scratch in order to produce the shots. The manufacturing problems that plagued the Maryland-based company also forced a delayed start to the phase 3 clinical trial. The company also struggled to meet the FDA’s purity standards for vaccines.
