With COVID-19 a fading worry, the Food and Drug Administration made significant changes Tuesday in its vaccine authorization, eliminating the original formula, shifting to favor a single dose of the updated shot and allowing new boosters for older and sicker people.
Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said the idea is to streamline COVID-19 vaccine guidance as the country transitions to managing the virus as an endemic or ever-present concern while spurring interest in the shots, particularly among those who are most vulnerable.
“COVID-19 continues to be a very real risk for many people,” Marks said in a statement. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
The FDA’s changes are:
- The original COVID shots are no longer authorized in the U.S. That’s the Pfizer and Moderna COVID-19 messenger-RNA vaccines based on the original strain of the SARS-CoV-2 virus that emerged in Wuhan, China, in late 2019 and were given as a two-dose primary series starting in December 2020. That strain has long been replaced by a series of variants, including the current omicron.
- One shot gets you caught up. Most people who haven’t yet had a shot of the updated “bivalent” vaccine based on both the Wuhan and more recent omicron strains can now receive a single dose. That includes the 30% of Americans who didn’t get vaccinated with the two-shot primary series of the original vaccine. Children 6 months to 5 years old who are unvaccinated or who had the original vaccine can receive multiple doses of the bivalent vaccine for kids.
- Older and vulnerable adults can get another booster. If you are 65 or older and already had a dose of the bivalent vaccine, you can now get a second booster of that shot after at least four months. Those with compromised immunity who had a dose of the bivalent vaccine also may…
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