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The Food and Drug Administration on Monday granted full regulatory approval to Moderna’s coronavirus vaccine for adults, marking the second such authorization for a COVID-19 vaccine in the U.S.
“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”
More than 200 million doses of Moderna’s vaccine, which the company named “Spikevax,” have been administered in the U.S. under an emergency use authorization, according to data from the Centers for Disease Control and Prevention.
“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Moderna CEO Stéphane Bancel said in a statement.
Cartoons on the Coronavirus
Pfizer’s vaccine was granted full approval in August for people ages 16 and over, marking the first COVID-19 shot to be granted approval beyond emergency use authorization in the U.S. More than 315 million Pfizer doses have been administered across the country.
Public health officials have expressed hope that full approval would reinforce vaccine safety and spur more people to get the shots, but surveys indicated that full approval of the Pfizer shot moved the needle very little.
Roughly 25% of Americans have yet to receive a single coronavirus vaccine shot, according to CDC data.