Moderna vaccine granted full approval by U.S. health regulators

(AP) – Moderna announced Monday that U.S. health regulators granted full approval to its COVID-19 vaccine, a shot that’s been given to tens of millions of Americans since its emergency authorization over a year ago.

The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines.

The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020.

The FDA granted full approval of Pfizer’s vaccine last August.

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.

Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.