The coronavirus vaccine made by Moderna is highly protective for adults and prevents severe cases of Covid-19, according to data released on Tuesday by the U.S. Food and Drug Administration.
Based on the encouraging findings, the agency intends to grant emergency authorization for use of the vaccine on Friday, people familiar with the F.D.A.’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as next week.
The review by the F.D.A. confirms Moderna’s earlier assessment that its vaccine had an efficacy rate of 94.1 percent in a trial of 30,000 people. Side effects, including fever, headache and fatigue, were unpleasant but not dangerous, the agency found.
The success of Moderna’s vaccine has become all the more crucial to fighting the pandemic as other vaccine efforts have faltered. The hopeful news arrives at a time of record-breaking numbers of new coronavirus cases in the United States, which are overwhelming hospitals, and of an ever-increasing total death toll, which reached a bleak milestone of 300,000 on Monday.
The data release is the first step of a public review process that will include a daylong meeting on Thursday by an independent advisory panel of experts. They will hear from Moderna, F.D.A. scientists and the public before voting on whether to recommend authorization. The panel is expected to vote in favor, and the F.D.A. generally follows the experts’ recommendations.
Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already being shipped by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine given emergency clearance last Friday. Health care workers received the first shots on Monday of the Pfizer-BioNTech vaccine, which has an efficacy rate of 95 percent.
The rollout of vaccines has been highly anticipated, and is one of the most ambitious immunization campaigns ever conducted in the United States.
The federal government signed deals last summer with Moderna and Pfizer to deliver a total of 200 million doses in the first quarter of 2021. Because both vaccines require two doses, those contracts guaranteed enough shots for 100 million people.
Last week, the U.S. government announced that it had purchased another 100 million doses from Moderna for the second quarter, increasing the number of Americans who could be vaccinated to 150 million. But that still leaves the question of how and when the roughly 180 million other Americans will be covered.
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