Moderna scores FDA authorization for its COVID-19 vaccine, adding key 2nd shot as nationwide campaign ramps up

Nursing home vaccine
Moderna's coronavirus vaccine scored an FDA emergency use authorization, setting the stage for a nationwide rollout. (Getty/bymuratdeniz)

When COVID-19 began spreading earlier this year, the prospect of coronavirus vaccines launching before year’s end seemed like the longest of long shots. Now, partly in thanks to the research partnership between the federal government and industry, the U.S. has its second authorized COVID-19 vaccine. 

The FDA on Friday evening cleared Moderna’s mRNA vaccine, mRNA-1273, for emergency use in people 18 years and older. The authorization allows the company and federal government to immediately distribute the shot nationwide; it comes a week after Pfizer and BioNTech's emergency vaccine nod. 

It also adds a key second option—and more vaccine supplies—amid the United States' nationwide vaccination push. Moderna has said it should be able to distribute 20 million doses in the U.S. by the end of the year, while Pfizer has pledged 25 million doses. 

Next year, dose distribution and availability should ramp up considerably. Pfizer and Moderna each say they’re on track to deliver 100 million doses by the end of the first quarter. Pfizer and the federal government are in talks for more doses, while Moderna just inked a new pact for another 100 million doses to be delivered in the second quarter. 

The FDA’s Moderna decision came after a Thursday advisory committee hearing on the mRNA vaccine's data. During the meeting, panelists voted 20-0, with one abstention, that the benefits of the vaccine outweighed its risks for use in people 18 and older. The one expert who abstained said in the “midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 and older is just too broad.”  

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That a second coronavirus vaccine is launching 11 months after the United States’ first case is a remarkable scientific feat. This spring, federal researchers—in partnership with Moderna—reached human testing 66 days after receiving the Sars-CoV-2 viral sequence. That was a record, Kizzmekia Corbett, the scientific lead for the coronavirus program at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, said at the time.  

In a note Wednesday, Bernstein analysts said they expect 200 million Americans will be vaccinated against the novel coronavirus by May 31, and that the people remaining at that point will either have refused the vaccine or found themselves ineligible. The analysts expect hundreds of millions of doses from Pfizer and Moderna to be delivered through their Operation Warp Speed deals, but also expect "some contribution” from the Johnson & Johnson and Novavax programs. Those companies are set to report efficacy data in early 2021. 

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As the first-to-market vaccines, Pfizer and Moderna are set to earn billions of dollars in revenue next year. Bernstein analysts have predicted the COVID-19 vaccine market will be worth $38.5 billion in 2021, with Pfizer taking a $14.3 billion slice and Moderna earning $10.3 billion from its shot. J&J, Novavax and AstraZeneca are also in line for multibillion-dollar coronavirus vaccine revenues next year, the analysts wrote.