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Moderna gets full FDA approval for vaccine given to 200 million Americans

About two years in and 75 million pandemic infections later, the Food and Drug Administration granted full approval Monday to Moderna’s vaccine against the novel virus that causes COVID-19.

The federal regulatory committee said that, after reviewing months of data, it has concluded that the two-dose regimen of Moderna's newly tagged Spikevax is safe and effective at preventing the novel coronavirus in individuals 18 years of age and older. 

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said acting FDA commissioner Janet Woodcock in a statement Monday of the nation’s second-most-used vaccine, behind Pfizer. 

Roughly 211 million Americans, 64% of the population, are fully vaccinated while 12% are estimated to be partially vaccinated.

Moderna officials welcomed the news, noting this is the Cambridge, Massachusetts-based company’s first FDA-approved product and that Moderna’s vaccine has been approved for adults by regulators in Canada, Japan, the European Union, the United Kingdom, Israel and other countries, as well as for adolescents.

“We are grateful to the U.S. FDA for their thorough review of our application,” said Moderna CEO Stéphane Bancel in a statement. “We are humbled by the role that Spikevax is playing to help end this pandemic.”

Having received emergency authorization in December 2020, around 200 million Americans have already received Moderna’s shot.

Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks added Monday that the evaluation of the scientific data submitted by Moderna to the FDA included reviewing the manufacturing quality of Spikevax. 

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“The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,” Marks said.

Moderna is still approved only for those 18 and older in the U.S. for its two doses of vaccination and booster.

The Spikevax vaccine does comes with a warning about one serious, but rare, side effect — heart inflammation that can occur, “with the observed risk highest in males 18 through 24 years of age,” after the second dose. However, the regulator noted that the effects are usually mild and quickly resolved.

Because of the risk of heart inflammation with its shot, Moderna has said previously that the FDA has delayed its call about whether the shots can safely be given to 12- to 17-year-olds.

The FDA granted full approval to Pfizer, and its partner BioNTech, for their two-dose regimen in August for use in those 16 years and up and has since granted emergency use authorization for teens and kids. This approval was followed by federal vaccination mandates enacted by the Biden administration that have acted as kindling for a number of lawsuits, including one that has since made its way up to the Supreme Court.

While there was no notable increase in the number of Americans getting vaccinated after the FDA issued full approval for Pfizer’s jab, the FDA’s Woodcock expressed hope Monday that her administration’s green light for Moderna would instill Americans with more confidence in the company’s vaccines and encourage those who haven’t yet gotten inoculated to roll up their sleeves.

Johnson & Johnson, which makes the only single-dose vaccine approved for emergency use in the U.S., has yet to apply to the FDA for full approval.

The latest wave of COVID-19, driven by the highly contagious Omicron variant, has been driving up the daily American death toll. While Omicron is said to cause less severe disease in most people, the variant’s highly transmissible nature means more people have succumbed and died.

Scientists have expressed concern that a wave of long COVID cases, wherein those who have contracted COVID-19 develop lingering health problems, could be next on the horizon.

The country is averaging around 750,000 vaccinations per day, down from the peak rate of 3 million per day in the U.S. in the spring of 2021. Around 86 million Americans are estimated to have gotten a booster. 

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The number of COVID-19 cases in the U.S. appears to be slowing, down to roughly 520,000 per day as of Jan. 29 after reaching an all-time high of roughly 800,000 per day in mid-January.

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Moderna is still approved only for those 18 and older in the U.S. for its two doses of vaccination and booster.