vaccine
Moderna Vaccine Is Highly Protective Against Covid-19, the F.D.A. Finds
The positive review most likely ensures that the Food and Drug Administration will grant emergency authorization to a second coronavirus vaccine this week for millions of Americans.
By Noah Weiland, Denise Grady and Carl Zimmer
Dec. 15, 2020
Leer en español
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
newsweek times.
The positive review most likely ensures that the Food and Drug Administration will grant emergency authorization to a second coronavirus vaccine this week for millions of Americans.
By Noah Weiland, Denise Grady and Carl Zimmer
Dec. 15, 2020
Leer en español
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
newsweek times.
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