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# Moderna Covid Vaccine Now Approved as Spikevax
- URL: https://www.fdaweb.com/moderna-covid-vaccine-now-approved-as-spikevax/
- Published: 2022-01-31T12:00:00.000Z
- Updated: 2026-09-14T17:30:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151045

FDA 1/31 has granted full approval to Moderna’s Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older. The previous vaccine, which was previosly available under an emergency use authorization (EUA), joins the Pfizer-BioNTech Covid-19 vaccine Comirnaty as the only approved vaccines for preventing the disease.

Spikevax’s approval was based on FDA’s evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported a 12/2020 EUA for the vaccine and information from post EUA experience. “The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose,” an [agency release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine?ref=fdaweb.com) says. “The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that Spikevax was 93% effective in preventing Covid-19, with 55 cases of Covid-19 occurring in the vaccine group and 744 Covid-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.”

The agency says it is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Spikevax. “These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Spikevax,” it says. “In addition, although not FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Spikevax during pregnancy.”