U.S. health regulators on Monday granted full approval to Moderna's COVID-19 vaccine, a shot that's already 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.
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 Joe Biden and other federal officials. Still, regulators said Monday they hoped the extra endorsement would encourage more people to get vaccinated.
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.
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