The U.S. Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Moderna’s COVID-19 vaccine to prevent COVID-19 in people 18 years and older.
The mRNA vaccine will be called Spikevax, Moderna said. The vaccine has the same formulation as Moderna’s COVID-19 Vaccine, which has been available in through an emergency use authorization (EUA) since December 18, 2020, the FDA said.
Acting FDA Commissioner Janet Woodcock, MD, said, “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
The Moderna COVID-19 vaccine is the second to receive full approval from the FDA, which has also granted full approval to the COVID-19 vaccine from Pfizer and BioNTech.
The FDA based its decision on the totality of scientific evidence shared by the company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure.
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% 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.
More than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.