The FDA’s vaccine advisors are scheduled to meet on Tuesday to consider authorizing the Novavax COVID-19 vaccine.
on Friday, saying that the rate of myocarditis is “within the expected rate” and similar to the groups that received a placebo. The company added there is “insufficient evidence” to establish a causal relationship between the vaccine and myocarditis or pericarditis.
“We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk,” the company said. “Myocarditis is most often caused by nonspecificIn the FDA briefing document, the agency summarized that the “known benefits” among Novavax vaccine recipients relative to the placebo include a “reduction in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination.
In addition, the vaccine is seen as another option for those who remain unvaccinated. Novavax developed a protein subunit vaccine, which is a more traditional type than the mRNA technology used for the Moderna and Pfizer shots. Other well-known subunit vaccines include the
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