The agency's decision was based on scientific evidence shared by Moderna in its submission package, which included six-month follow-up data from a Phase 3 clinical trial study as well as manufacturing and facilities data required by the FDA.
The FDA also analyzed and kept watch for serious side effects that have proved to be very rare. The vaccine includes a warning about a rare type of heart inflammation that mostly occurs in young men following the second dose. Most cases are mild and resolve quickly.
"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," Moderna CEO Stéphane Bancel said in a statement. "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."
Moderna's vaccine has been available in the U.S. under an emergency use authorization since December 2020. Spikevax has already received approval in more than 70 countries, including Canada, Japan, the European Union, the U.K. and Israel. In 2021, Moderna shipped 807 million doses of the vaccine globally.
"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," acting FDA Commissioner Janet Woodcock added. "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."
In the U.S., Moderna is used only by adults for initial vaccination and as a half-dose booster. The company said last fall that the FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined the heart inflammation risk.
|JNJ||JOHNSON & JOHNSON||181.09||+1.63||+0.91%|
Meanwhile, the FDA granted full approval of Pfizer’s vaccine last August. Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.
The Associated Press contributed to this report