The FDA has officially approved the Moderna COVID-19 vaccine – which will be marketed as Spikevax – for the prevention of COVID-19 in adults aged 18 and older.
Until now, the Moderna vaccine had only received emergency use authorization (EUAs). EUAs are declarations that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products.
The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients who did not have evidence of COVID-19 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 and 98% effective in preventing severe disease.
In related news, the FDA also expanded the approved indication for Veklury (remdesivir), an antiviral used to treat COVID-19. Veklury was originally indicated to treat hospitalized patients with COVID-19 to prevent serious disease progression. Veklury is now approved to treat non-hospitalized patients weighing at least 88 pounds and who are at high risk for progression to severe COVID-19.
Veklury’s approval for non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19. Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.
Veklury is not a substitute for vaccination, and vaccination and a booster dose are recommended for all individuals, unless not medically feasible.
And in other news, the FDA also revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab). Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.