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.
Public health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernable bump in vaccinations after the Pfizer approval, which was heavily promoted by President Biden and other federal officials. Still, regulators said Monday they hoped the extra endorsement would encourage more people to get vaccinated.Experts say about most Americans will need to be vaccinated to bring the coronavirus pandemic under control.
More than 211 million Americans, or 63% of the total population, are fully vaccinated. 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.
The FDA reviewed months of additional follow-up data submitted by Moderna to confirm the vaccine’s effectiveness against COVID-19. 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.
With full approval, Moderna will now market the vaccine under the brand name, Spikevax. It is the first FDA-approved product for the Cambridge, Massachusetts-based company.Tens of millions of Americans remain unvaccinated against COVID-19. For many, their stance on the vaccine may cost them their paychecks.
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 FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined the heart inflammation risk.AP Medical Writer Lauran Neergaard contributed to this report.
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