Moderna's two-dose vaccine, now fully approved by The Food and Drug Administration (FDA) for adults, became the second COVID-19 vaccine in the United States to receive final approval from federal regulators.
Pfizer's vaccine received full FDA approval for people 16 and older in 2021, sparking hopes that a new wave of Americans who were wary of the vaccine would get the shots.
While Moderna's vaccine, named Spikevax, is available to people 18 and older, it is not approved for use in younger individuals. Pfizer's vaccine, named Comirnaty, carries emergency authorization for use in children 5 and up. And pediatricians recommend they get it.
Building vaccine confidence
One consistent criticism from those who were hesitant to get vaccinated is that the vaccines had only received emergency use authorization (EUA), which provides access to medical products that may be effective in preventing or treating a disease, provided the FDA determines its potential benefits outweigh the potential risks.
While there's no difference between the FDA-approved vaccines and those previously available through EUA, full approval means the vaccines have cleared a higher bar of review. The bottom line, doctors say, is that the mRNA vaccines are safe and effective.
"It's really a moment to celebrate," said Dr. David Priest, Novant Health senior vice president and chief safety, quality, and epidemiology officer. After reviewing hundreds of thousands of documents related to the clinical trials and other data related to millions of doses around the world, "the FDA said they are confident this is a safe product."
COVID-19, now largely a pandemic of the unvaccinated, has killed more than 884,000 Americans. And the latest approval comes as hospitals begin to fill with patients from yet another surge that is straining capacity across the U.S.
Novant Health even required team members to get vaccinated, as did multiple other large health care systems across North Carolina and the U.S. Patient safety drove the decision at Novant Health. “Vaccines are the only way we have at this time to end this pandemic,” Priest said, “and the only way to ensure that we do not give a deadly virus to those who trust us.”
More than 10 billion doses of COVID-19 vaccines have been safely administered worldwide, with millions more each day, and the vaccine has been proven highly effective at preventing serious illness. Though data varies by state, more than 90% of hospitalized patients in the U.S. are unvaccinated, according to press and public health reports.