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FDA Researchers Endorse Moderna COVID-19 Vaccine

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Scientists at the Food and Drug Administration endorsed the COVID-19 vaccine developed by Moderna as safe and efficacious on Tuesday, one day after the first doses of a competing vaccine from Pfizer and BioNTech were delivered across the United States.

The FDA reviewers said that the two-dose vaccine “was highly effective” in preventing symptomatic COVID-19 from occurring “at least 14 days after the receipt of the second dose.”

Vaccine-related side effects, such as aches and pains, appeared more severe than with the Pfizer/BioNTech vaccine, though such comparisons should be made with caution and are in no way expected to slow the clearance of the vaccine or present major concerns. There was also preliminary evidence that the vaccine has some efficacy after one dose, and that it prevents asymptomatic COVID-19 cases — those that occur without a person ever feeling ill.

Moderna disclosed Nov. 30 that its vaccine decreased symptomatic COVID-19 infections by 94% in clinical trials, while also preventing more severe forms of the disease. But the release of FDA documents provides the most complete look yet at what is likely to be the second COVID-19 vaccine cleared for emergency use against the disease.

Read the full story from STAT.

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Matthew Herper and Damian Garde, STAT

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