FDA Approves Second COVID-19 Vaccine

The US Food and Drug Administration (FDA) has approved a second COVID-19 vaccine for use in adults aged 18 years or older.

This vaccine, marketed as Spikevax, is the same formulation as the Moderna COVID-19 vaccine that has been available under an emergency use authorization (EUA) since December 2020. The Moderna vaccine is still available to certain patient populations under the EUA and can be used interchangeably with the Spikevax vaccine. Similar to the Moderna vaccine, Spikevax is administered in a 2-dose series given 1 month apart.

The approval was based on an ongoing randomized clinical trial. The results indicated that Spikevax was 93% effective in preventing COVID-19 and 98% effective in preventing severe disease. A total of 55 cases had occurred in the vaccine group (n = 14,287) and 744 cases in the placebo group (n = 14,164).

Pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm, and fever were among the most common adverse effects reported.

While the Spikevax vaccine includes a warning about the increased risk of myocarditis and pericarditis, the FDA has determined that the benefits of vaccination outweigh these risks. Additional studies on the risk of myocarditis and pericarditis, as well as the safety of vaccination with Spikevax during pregnancy, are ongoing.

—Leigh Precopio

Reference:

Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine. News release. US Food and Drug Administration; January 31, 2022. Accessed February 1, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine