As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday.
The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing process.
Novavax’s product is a protein subunit vaccine that contains the SARS-CoV-2 spike protein plus an adjuvant to enhance the recipient’s immune response. The product is to be administered as a two-dose primary series given 3 weeks apart.
“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert Califf, MD, in a press release. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
In considering Novavax’s EUA, FDA analyzed effectiveness data from an ongoing randomized trial conducted in the U.S. and Mexico that included more than 25,000 people. The vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19, with zero cases of moderate or severe COVID-19 among vaccine recipients.
However, the trial was conducted before the Delta and Omicron variant waves, and does not provide longer-term information on whether protection wanes, as has been observed with mRNA vaccines.
FDA in early June had also expressed concerns about heart inflammation — the same rare side effect associated with the mRNA vaccines from Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) — among Novavax vaccine recipients. The manufacturer’s response was that the rate of myocarditis was balanced between the vaccine and placebo arms.
To date, there are approximately 21,000 Novavax recipients with at least 2 months of follow-up for safety data. According to the FDA, the most commonly reported side effects included pain and tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea and vomiting, and fever.
“The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review,” said Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation and Research.
CDC’s Advisory Committee on Immunization Practices must still give the go-ahead before the vaccine can be administered.
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