WASHINGTON — The coronavirus vaccine made by Moderna is highly protective, according to new data released on Tuesday, setting the stage for its emergency authorization this week by federal regulators and the start of its distribution across the country.
The Food and Drug Administration intends to authorize 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 authorized.
“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 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 common and unpleasant, but not dangerous, the agency found.
The F.D.A. said its analysis “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization.”
The success of Moderna’s vaccine has become all the more critical to fighting the pandemic as other vaccine efforts have faltered. 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, F.D.A. scientists and the public before voting on whether to recommend authorization. The panel is expected to vote yes, 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. Health care workers received the first shots on Monday of that vaccine, which has an efficacy rate of 95 percent.
Emergency authorization 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.
Barry R. Bloom, a professor of public health at Harvard, said the results from Moderna and Pfizer were “extraordinarily comparable.”
“The good news is they both did everything they were supposed to do,” he said. Based on the data, Moderna’s vaccine may be slightly less effective in people 65 and older than Pfizer-BioNTech’s. “But it’s hard to tell,” he said.
Compared with the Pfizer-BioNTech vaccine, Moderna’s was more likely to cause headaches, sore arms and related side effects, Dr. Bloom noted.
The vaccine rollout is one of the most ambitious in the nation’s history, but experts are uncertain how long it will take for all 330 million Americans to be inoculated, let alone return the country’s businesses, schools and everyday routines to a new normal.
Last summer, the U.S. government signed deals with Moderna and Pfizer to acquire 200 million doses in the first quarter of 2021. Because both vaccines require two doses, those contracts guaranteed enough doses for 100 million people. The government announced last week that it had purchased another 100 million doses from Moderna for the second quarter, increasing the number to 150 million who can be vaccinated.
Both vaccines will be provided free of charge.
Because Moderna’s vaccine requires less extreme cold storage than the Pfizer-BioNTech product, it will be easier to ship, store and handle.
“Moderna is the one that I would take out to rural areas and community health centers and private doctors’ offices,” Dr. Bloom said, adding that hospitals would be better equipped to deal with the Pfizer-BioNTech vaccine.
发表回复