Moderna Vaccine Next in Line for Emergency Use Authorization

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Moderna Inc.’s vaccine is safe and effective for preventing Covid-19 in people ages 18 and older, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort.

The Food and Drug Administration’s staff said in a report on Tuesday that the experimental vaccine is 94.1% effective at preventing symptomatic Covid-19, confirming earlier results released by the company.

The report was posted online ahead of a meeting Thursday of agency advisers who will vote whether to recommend authorization before a final FDA decision. The agency doesn’t have to follow the advice of the independent vaccine experts, though it often agrees with its advisory panels. Last week, the FDA authorized a similar vaccine from Pfizer Inc. and BioNTech SE after an advisory panel voted 17-4, with one abstention, to support its authorization.

The FDA got a much deeper look at Moderna’s clinical-trial data than the numbers previously released to the public by the company. The agency found the shot was similarly effective across racial and ethnic groups and those with underlying medical conditions. It was 86.4% effective in people age 65 and over, according to the report, and 95.6% effective in those 18 to 65. The most common systemic side effects were fatigue and headache.

Both the Moderna and Pfizer products are based on messenger RNA technology that hasn’t been previously used in human vaccines. Because both are two-dose vaccines, people will need to return to their care providers weeks after their initial shot for a booster.

Between Pfizer and Moderna, Operation Warp Speed officials have said 20 million people in the U.S. are expected to get their first shots by year-end.

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