August 25, 2022

FDA Authorizes New COVID-19 Vaccine

The FDA has granted Emergency Use Authorization (EUA) to the Novavax COVID-19, Adjuvanted vaccine for individuals aged 18 and older.

This vaccine is administered in two primary doses given three weeks apart.

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study involving 17,200 people.  Overall, the vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19.

Approximately 17 mild cases of COVID-19 occurred in the vaccine group, with 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in placebo recipients.

The safety of the vaccine was assessed in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received placebo. The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever.

Approximately 21,000 vaccine recipients had at least two months of safety follow-up after their second dose.

This vaccine utilizes a different technology than other COVID-19 vaccines and was recently endorsed by the Centers for Disease Control and Prevention.

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