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FDA finding: Moderna vaccine 'highly protective' against COVID-19

The coronavirus vaccine made by Moderna is highly protective, according to new data released this week, reports The New York Times, setting the stage for its emergency authorisation 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, 18 December, 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.

The review by the FDA 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 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 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.

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. 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.

 

[link url="https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement#event-materials"]FFDA documentation relating to Moderna release[/link]

 

[link url="https://www.nytimes.com/2020/12/15/health/covid-moderna-vaccine.html"]Full report in The New York Times (Registration or subscription required)[/link]

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