JUST IN: FDA gives 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 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 ofPublic 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.
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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