FDA’s New COVID Vaccine Policy May Limit Who Gets New Shots. Here’s What To Know
The post FDA’s New COVID Vaccine Policy May Limit Who Gets New Shots. Here’s What To Know appeared on BitcoinEthereumNews.com. Topline The Food and Drug Administration announced Tuesday it is adopting a new regulatory framework for COVID-19 vaccines that will likely narrow recommendations for the vaccines to people over 65 and those at high risk for severe outcomes—a switch that could limit access to the vaccines to many others. Adams 12 Five Star Schools District RN Tiffany Karschamroon draws a dose from a vial of the Johnson … More & Johnson COVID-19 vaccine on March 6, 2021 in Thornton, Colorado. Getty Images Key Facts FDA Commissioner Marty Makary and Vinay Prasad, the agency’s top vaccine regulator, said in an article published in the New England Journal of Medicine Tuesday the U.S. will no longer follow a “one-size-fits-all regulatory framework” on COVID-19 vaccines. Makary and Prasad said the FDA expects it will be able to determine whether benefits outweigh risks for adults over 65 and people older than six months with high risk based on “immunogenicity,” or “proof that a vaccine can generate antibody titers in people.” But for vaccines to receive a green light for the general public between six months and 64-years-old without health risks, the FDA will require “randomized, controlled trial data evaluating clinical outcomes” before a vaccine is approved. The change will also more closely align the U.S.’ policy to that of other countries, including the United Kingdom, Canada and Australia, according to CNN. Crucial Quote “The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,” the two FDA leaders wrote in the article, adding: “We reject this view.” Key Background In late 2020, the FDA gave emergency use authorization to two COVID-19 vaccines, one from Pfizer and one from Moderna, and they were recommended first to healthcare workers and people with high risk…
The post FDA’s New COVID Vaccine Policy May Limit Who Gets New Shots. Here’s What To Know appeared on BitcoinEthereumNews.com.
Topline The Food and Drug Administration announced Tuesday it is adopting a new regulatory framework for COVID-19 vaccines that will likely narrow recommendations for the vaccines to people over 65 and those at high risk for severe outcomes—a switch that could limit access to the vaccines to many others. Adams 12 Five Star Schools District RN Tiffany Karschamroon draws a dose from a vial of the Johnson … More & Johnson COVID-19 vaccine on March 6, 2021 in Thornton, Colorado. Getty Images Key Facts FDA Commissioner Marty Makary and Vinay Prasad, the agency’s top vaccine regulator, said in an article published in the New England Journal of Medicine Tuesday the U.S. will no longer follow a “one-size-fits-all regulatory framework” on COVID-19 vaccines. Makary and Prasad said the FDA expects it will be able to determine whether benefits outweigh risks for adults over 65 and people older than six months with high risk based on “immunogenicity,” or “proof that a vaccine can generate antibody titers in people.” But for vaccines to receive a green light for the general public between six months and 64-years-old without health risks, the FDA will require “randomized, controlled trial data evaluating clinical outcomes” before a vaccine is approved. The change will also more closely align the U.S.’ policy to that of other countries, including the United Kingdom, Canada and Australia, according to CNN. Crucial Quote “The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,” the two FDA leaders wrote in the article, adding: “We reject this view.” Key Background In late 2020, the FDA gave emergency use authorization to two COVID-19 vaccines, one from Pfizer and one from Moderna, and they were recommended first to healthcare workers and people with high risk…
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