Moderna vaccine is highly protective against COVID-19, the FDA finds

The coronavirus vaccine made by Moderna is highly protective, according to new data released on Tuesday, setting the stage for its emergency authorisation this week by federal regulators and the start of its distribution across the country.

The Food and Drug Administration intends to authorise emergency use of the vaccine on Friday, people familiar with the agency’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as Monday. The Pfizer-BioNTech vaccine, cleared last week, was the first to be authorised.

“This is great news, as this now brings us to two products with high levels of efficacy,” said Rupali Limaye, an associate scientist at Johns Hopkins Bloomberg School of Public Health.

The review by the FDA confirms Moderna’s earlier assessment that its vaccine had an efficacy rate of 94.1% in a trial of 30,000 people. Side effects — including fever, headache and fatigue — were common and unpleasant, but not dangerous, the agency found.

The FDA said its analysis “supported a favourable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorisation.”

The hopeful news arrives at a time of record-setting numbers of coronavirus cases that are overwhelming hospitals and of an ever-increasing 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, FDA scientists and the public before voting on whether to recommend authorisation. The panel is expected to vote yes, and the FDA generally follows the experts’ recommendations.

Distribution of about 6 million doses could then begin next week, significantly adding to the millions of doses already being shipped by Pfizer and BioNTech. Health care workers received the first shots on Monday of that vaccine, which has an efficacy rate of 95%.

Emergency authorisation is not the same as full approval. It allows an experimental vaccine to be used if there is evidence that its potential benefits outweigh its risks, while more data is collected to apply for full approval.

© 2020 New York Times News Service