Moderna’s COVID-19 Vaccine Gets Full FDA Approval

(Washington DC) — Moderna announced Monday that U.S. health regulators have fully approved the COVID-19 vaccine, an injection given to tens of millions of Americans since its emergency clearance more than a year ago.

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

The decision was supported by real-world evidence from the more than 200 million doses administered in the US since the FDA approved the injection in December 2020. The FDA granted full approval for Pfizer’s vaccine last August.
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Public health proponents initially hoped the regulatory distinction would increase public confidence in the shots. But there was no discernible bump in vaccinations after Pfizer’s approval, which was heavily promoted by President Joe Biden and other federal officials.

More than 211 million Americans, or 63% of the total population, are fully vaccinated. About 86 million people have received a booster dose. Vaccinations peaked last spring at more than 3 million per day, and now average less than 750,000 per day. Vaccination rates picked up shortly after news of the ommicron variant in December, but have since slowed down again.

The FDA, like regulators in Europe and elsewhere, initially allowed the emergency use of Moderna’s vaccine based on a study that followed 44,000 people ages 18 and older for at least two months — the period when serious side effects typically occur. That’s shorter than the six months of safety data normally needed for full approval, so Moderna continued that study. The FDA also monitored serious side effects that have proven to be very rare.

In the US, Moderna is only used by adults. The company said last fall that the FDA had delayed deciding whether to clear its injections for 12- to 17-year-olds because it was investigating a rare risk of heart inflammation seen mainly in young men and teenage boys.

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

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AP Medical Writer Lauran Neergaard contributed to this report.

This post Moderna’s COVID-19 Vaccine Gets Full FDA Approval

was original published at “https://time.com/6143701/moderna-covid-19-vaccine-approval/”