Today the US Food and Drug Administration (FDA) granted full approval to the mRNA COVID-19 vaccine made by Moderna, which will now be known as Spikevax.The vaccine had been authorized for emergency use for more than a year and has been a mainstay of the US vaccination campaign.Approved for use in adultsSpikevax is approved for use in adults 18 and older as a two-dose vaccine with shots administered 1 month apart.
Spikevax can be mixed and matched with the Moderna emergency use authorized vaccine and used as a booster vaccine.To gain approval, Moderna submitted more data on the vaccine's effectiveness to the FDA, though it noted that the data predated the Omicron variant.
The updated analyses included 14,287 vaccine recipients and 14,164 placebo recipients who had never had COVID-19.Spikevax was 93% effective in preventing COVID-19 and 98% effective in preventing severe disease."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," said Acting FDA Commissioner Janet Woodcock, MD, in a press release. "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 United States.""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," Woodcock added.In August of last year, the FDA granted full approval to the Pfizer/BioNTech vaccine, known as Comirnaty.The Centers for Disease Control and