Moderna has announced that U.S. health regulators granted full approval to its COVID-19 vaccine. The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S.
— 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 itsThe 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 grantedPublic health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernible bump in vaccinations after the Pfizer approval, which was heavily promoted by President Joe Biden and other federal officials.. About 86 million people have gotten a booster dose.
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 watch 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.AP Medical Writer Lauran Neergaard contributed to this report.
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