Moderna’s COVID-19 vaccine has been given full approval from the U.S. Food and Drug Administration, a shot that has been administered to millions of Americans throughout the course of the pandemic.
The approval for those aged 18 and up came after the agency reviewed more data on the safety and effectiveness of the Moderna’s shot, marketed as "Spikevax." Full approval by the FDA means it has completed the same rigorous, time-consuming review as dozens of other long-established vaccines.
In a statement, Moderna CEO Stephane Bancel called the full approval "a momentous milestone in Moderna's history" as it becomes the company's first product to achieve licensure in the U.S.
"The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus," Bancel said. "We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."
The decision was bolstered by real-world evidence from the more than 204 million doses administered in the U.S. since the FDA cleared the shot in December 2020 under an Emergency Use Authorization. The difference between EUA and full FDA approval is that they require different clinical study requirements — with full FDA approval requiring a longer monitoring period.
The FDA granted full approval of Pfizer’s vaccine last August.
The FDA, like regulators in Europe and elsewhere, initially allowed emergency use of Moderna’s vaccine based on a study that tracked 44,000 people 18 and older for at least two months, the time period when serious side effects typically arise. That's shorter than the six months of safety data normally required for full approval, so Moderna continued that study.
The FDA also kept watching for serious side effects that have proved to be very rare.
In the U.S., Moderna is used only by adults. The company said last fall that FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined a rare risk of heart inflammation seen mostly in young men and teen boys.
To date, more than 211 million Americans — or 63% of the total population — are fully vaccinated, data from the U.S. Centers for Disease Control and Prevention shows. About 86 million people have gotten a booster dose.
Vaccinations peaked last spring at more than 3 million per day and now average less than 750,000 per day. The pace of vaccinations briefly spiked following news of the omicron variant in December but has since slowed again.
Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.
This story was reported from Cincinnati. The Associated Press contributed.