Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA

The US Food and Drug Administration (FDA) has approved a second COVID-19 vaccine. The approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. 

Spikevax has the same formulation as the Emergency Use Authorization (EUA) Moderna COVID-19 vaccine (which has been available since 18 December 2020) and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine to provide the COVID-19 vaccination series.

BREAKING: The @FDA has approved the Biologics License Application (BLA) for SPIKEVAX™ (COVID-19 Vaccine, mRNA) to prevent #COVID19 in individuals 18 years of age and older. pic.twitter.com/Ska7SYBALr

— Moderna (@moderna_tx) January 31, 2022

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the US,” said Acting FDA Commissioner Dr Janet Woodcock.

Moderna COVID-19 vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorised for use as a heterologous (or ‘mix and match’) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. 

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The approval of Spikevax is based on the FDA’s evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomised, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 vaccine and information from post EUA experience to further inform safety and effectiveness.  

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. The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that Spikevax was 93 percent 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 percent effective in preventing severe disease.