FDA fully approves Moderna COVID vaccine, Spikevax

Moderna vials and syringes
Moderna vials and syringes

Eric Garcetti / Flickr cc

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 adults

Spikevax 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 Prevention (CDC) COVID Data Tracker shows that 63.8% of Americans are fully vaccinated against COVID-19, 75.3% have received at least one dose of vaccine, and 41.5% of vaccinated Americans have received a booster dose.

Half of states note Omicron subvariant

Nearly half of all states in the country have confirmed the presence of the Omicron subvariant BA.2, with at least 127 known cases nationwide as of late last week, CNBC reports.

The variant is 1.5 times more transmissible than the original Omicron strain (see today's CIDRAP News story), which was already more transmissible than previous strains seen in the pandemic. There is no evidence the subvariant is more severe.

According to the New York Times tracker, the United States reported 519,421 new COVID-19 cases yesterday, including 2,524 deaths. According the newspaper, the United States will likely hit 900,000 deaths due to the virus by mid-February.

Late last week, the Financial Times published a model showing that if the United States had matched vaccination rates with European countries, hospitalizations during this latest stage of the pandemic would have been halved.

Though cases are dropping across the country, hospitalizations and deaths remain high. The Department of Health and Human Services' Protect Public Data Hub shows that 134,108 inpatient beds are in use for COVID-19.

Other US developments

  • New York City Mayor Eric Adams said yesterday that the city's health department is now offering free, same-day, at-home delivery of COVID-19 oral antiviral medications, ABC News reports.

  • The Labor Department is in the early stages of working to create a permanent set of coronavirus safety rules for healthcare facilities, according to the Washington Post. The policy would include things like mandatory mask-wearing, social distancing, and new cleaning and disinfection procedures.

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