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Federal government wants to deliver vaccine shots within a day or two of FDA approval, officials say

October 16, 2020. Summarized by summa-bot.

A health worker wearing a protective mask works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images

The federal government hopes to start vaccinating people against coronavirus within a day or two of Food and Drug Administration emergency authorization, officials said Friday.

The federal government hopes to start vaccinating people against coronavirus within a day or two of Food and Drug Administration emergency authorization, officials said Friday.

Mango was announcing a plan for retail pharmacy chains CVS and Walgreens to distribute any eventual coronavirus vaccine to long-term care facilities such as nursing homes under an agreement – not a contract – with the federal government’s Operation Warp Speed.

“We believe that this plan will be the quickest and easiest way to provide vaccines to long-term care facility residents,” Butler told reporters.

As the number of Covid-19 hospitalizations tick up in the United States, an increase in the number of deaths will likely follow, Dr. Francis Collins, the director of the National Institutes of Health, warned Friday.

Nearly a quarter of all the deaths in the pandemic have been in places where people live in group settings at a nursing home or long-term care facilities.

The federal government has designated CVS and Walgreens to distribute any coronavirus vaccine that eventually gets authorized to long-term care facilities such as nursing homes, Operation Warp Speed officials said Friday.

The two drug chains are best placed to send out mobile units to vaccinate seniors and other vulnerable people on site, Paul Mango, deputy chief of staff for policy at the Health and Human Services Department, told reporters in a telephone briefing.

Dr. Anthony Fauci, the nation's leading infectious disease expert, will be among the first people to see the data that will tell the country whether one of the experimental coronavirus vaccines being tested actually works to protect against the virus, the National Institutes of Health confirmed Friday.

The US Food and Drug Administration’s two month follow-up requirement for Covid-19 vaccine candidates is necessary to keep people safe and encourage confidence in a vaccine given emergency use authorization, two senior FDA officials said Friday.

While the follow-up period is shorter than those included in most vaccine clinical trials, Gruber and Krause say that the “gravity of the current public health emergency and the importance of making a vaccine available as soon as possible,” warrant the decision.

Gruber and Krause noted that evaluation of a Covid-19 vaccine should continue even after emergency use authorization (EUA) is issued, so the trials can yield the data required for full FDA approval.

People who get any vaccine released under an EUA will be told it is not fully approved, Gruber and Krause said.

“At stake is public confidence in America’s response to the pandemic, in Covid-19 vaccines, and in vaccines in general, all of which are essential to achieving desired public health outcomes,” they added.

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