The US Food & Drug Administration (FDA) has granted an emergency use authorisation (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced last Wednesday.
The Centres for Disease Control and Prevention’s Advisory Committee on Immunisation Practices must still give the go-ahead before the vaccine can be administered, but, reports MedPage Today, the decision follows a near-unanimous FDA advisory committee recommendation more than a month ago.
The FDA had analysed effectiveness data from an ongoing randomised trial conducted in the US 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.
In early June, the FDA 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.
The EUA was reportedly delayed 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 three weeks apart.
To date, there are 21,000 Novavax recipients with at least two 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.
MedPage Today article – Long-Denied COVID Vax Lands Authorization (Open access)
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