WASHINGTON — The U.S. Food and Drug Administration on Wednesday amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster for people older than 65 and for people who are at risk.
The booster will be available to U.S. residents 65 and older, people ages 18 to 64 who are at high risk of severe COVID-19, and people ages 18 through 64 whose “frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19,” the FDA said in a news release.
Approximately 22 million Americans received their second dose of the Pfizer vaccine at least six months ago, The New York Times reported, citing statistics from the Centers for Disease Control and Prevention. About half of them are 65 and older, according to the newspaper.
Meanwhile, Americans who received the Moderna and Johnson & Johnson vaccines are waiting to hear whether they also can receive booster shots.
Breaking News: The FDA authorized Covid booster shots for Pfizer vaccine recipients who are over 65 or at high risk, including because of job-related exposure. https://t.co/rNJULZwVtw
— The New York Times (@nytimes) September 22, 2021
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” acting FDA Commissioner Janet Woodcock said in a statement. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for people with weakened immune systems, according to The Associated Press.
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The FDA’s recommendation could be followed by a decision by the CDC as early as Thursday, the Times reported. A CDC advisory committee is in the middle of a two-day meeting on the issue.
Wednesday’s decision was expected after the agency’s panel of advisers last week overwhelmingly rejected a plan rolled out by President Joe Biden last month. The panel voted Friday against recommending booster shots for all people aged 16 and older, saying that there was not enough evidence to widely support a third vaccine dose. The Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend booster shots for people aged 65 and older, and for those who are at high risk of severe COVID-19.
The FDA does not have to accept the recommendations made by the advisory committee, though the agency usually does.
“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2.”
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