The Food and Drug Administration on Saturday approved emergency use of a coronavirus vaccine made by a subsidiary of Johnson & Johnson.
The vaccine has two major differences from those made by Moderna and Pfizer/BioNTech. The shot is a one-dose vaccine, and unlike the other vaccines that require extremely cold storage, is more easily stored and shipped, according to Politico.
“We need vaccines that are effective and well-tolerated. And importantly, ones that are simple to deploy,” Gregory Poland, director of the Mayo Clinic’s vaccine research group, said Friday.
“A single-dose vaccine may be desirable for people who want to complete their immunization schedule quickly, do not want to return for a second dose or have difficulty returning for a second dose,” the federal Centers for Disease Control and Prevention said. “A single doses vaccine may also be beneficial for settings where a walk in model is used, or areas with less access to online scheduling models pose challenges.”
It’s objectively pretty incredible that one year to the day after the CDC warned community spread of COVID-19 was inevitable, we’re close to having three highly effective vaccines available in the US.
— Sylvan Lane (@SylvanLane) February 26, 2021
Isn’t the J&J Vaccine the one created by Operation Warp Speed under “President Trump”?
— Joe Montoro (@joemontoro) February 28, 2021
The FDA said it acted to protect American lives.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Dr. Janet Woodcock, M.D, according to a release on the FDA website.
“The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Woodcock said.
The vaccine can be used on people 18 and older, the FDA said.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19,” he said.
— Reuters (@Reuters) February 28, 2021
The FDA said that the vaccine it approved was “approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.”
“Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination,” the FDA reported.
The FDA said it does not know how long the immunity provided by the vaccine will last, and said there is no evidence to show being vaccinated prevents transmission of the virus.
The company plans to ship out 20 million doses by the end of March and 100 million doses by the end of June, according to Politico.
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