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Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with the Pfizer Covid-19 vaccine at Kedren Health in Los Angeles, California on April 15, 2021. (Photo: Allen J. Schaben/Los Angeles Times via Getty Images)
FDA Panel Recommends Pfizer Booster Shots for People 65+ and Especially Vulnerable
The scientific advisory committee voted down a recommendation for other adults.
Sep 17, 2021
A Food and Drug Administration advisory panel on Friday unanimously recommended booster shots of the Pfizer Covid-19 vaccine for U.S. adults age 65 and older, and those especially at risk from virus, while voting strongly against recommending the same for people between the ages of 16 and 64.
Though neither vote is binding, the agency is likely to follow the advice of the 18-member committee and is expected to issue a final decision on boosters--a topic of controversy in recent months, especially given the ongoing global inequity in terms of access to vaccines--as early as next week.
\u201cNow it\u2019s a unanimous YES -- @US_FDA committee has voted on a new question re boosters recommending a third dose for those 65+ and people with high risk of severe covid-19. Note that this is for EUA not approval.\u201d— Dr. Sanjay Gupta (@Dr. Sanjay Gupta) 1631910723
According to the Associated Press:
The decision was made by a committee of outside experts who advise the Food and Drug Administration.
In a surprising turn, the panel first rejected, by a vote of 16-2, boosters for nearly everyone.
Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups. Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population--namely, those most at risk from the virus.
While the Biden administration had set a public goal of enacting a booster program for all U.S. adults this fall, there has been consistent pushback from the scientific community over whether the evidence supported the need for such a sweeping policy.
"It's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health, told the New York Times.
\u201cDiscussing the FDA advisory committee's vote soon with @wolfblitzer on @CNNSitRoom.\n\nThey came to a reasonable middle-ground decision. The most important part is acknowledging that high-risk individuals (by age, medical condition, etc) should be able to get the booster shot.\u201d— Leana Wen, M.D. (@Leana Wen, M.D.) 1631915930
Dr. Ashish Jha, the dean of the Brown University School of Public Health, welcomed the panel's position, tweeting Friday that it is "clearly consistent with the evidence and this outcome should never have been in doubt."
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A Food and Drug Administration advisory panel on Friday unanimously recommended booster shots of the Pfizer Covid-19 vaccine for U.S. adults age 65 and older, and those especially at risk from virus, while voting strongly against recommending the same for people between the ages of 16 and 64.
Though neither vote is binding, the agency is likely to follow the advice of the 18-member committee and is expected to issue a final decision on boosters--a topic of controversy in recent months, especially given the ongoing global inequity in terms of access to vaccines--as early as next week.
\u201cNow it\u2019s a unanimous YES -- @US_FDA committee has voted on a new question re boosters recommending a third dose for those 65+ and people with high risk of severe covid-19. Note that this is for EUA not approval.\u201d— Dr. Sanjay Gupta (@Dr. Sanjay Gupta) 1631910723
According to the Associated Press:
The decision was made by a committee of outside experts who advise the Food and Drug Administration.
In a surprising turn, the panel first rejected, by a vote of 16-2, boosters for nearly everyone.
Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups. Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population--namely, those most at risk from the virus.
While the Biden administration had set a public goal of enacting a booster program for all U.S. adults this fall, there has been consistent pushback from the scientific community over whether the evidence supported the need for such a sweeping policy.
"It's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health, told the New York Times.
\u201cDiscussing the FDA advisory committee's vote soon with @wolfblitzer on @CNNSitRoom.\n\nThey came to a reasonable middle-ground decision. The most important part is acknowledging that high-risk individuals (by age, medical condition, etc) should be able to get the booster shot.\u201d— Leana Wen, M.D. (@Leana Wen, M.D.) 1631915930
Dr. Ashish Jha, the dean of the Brown University School of Public Health, welcomed the panel's position, tweeting Friday that it is "clearly consistent with the evidence and this outcome should never have been in doubt."
A Food and Drug Administration advisory panel on Friday unanimously recommended booster shots of the Pfizer Covid-19 vaccine for U.S. adults age 65 and older, and those especially at risk from virus, while voting strongly against recommending the same for people between the ages of 16 and 64.
Though neither vote is binding, the agency is likely to follow the advice of the 18-member committee and is expected to issue a final decision on boosters--a topic of controversy in recent months, especially given the ongoing global inequity in terms of access to vaccines--as early as next week.
\u201cNow it\u2019s a unanimous YES -- @US_FDA committee has voted on a new question re boosters recommending a third dose for those 65+ and people with high risk of severe covid-19. Note that this is for EUA not approval.\u201d— Dr. Sanjay Gupta (@Dr. Sanjay Gupta) 1631910723
According to the Associated Press:
The decision was made by a committee of outside experts who advise the Food and Drug Administration.
In a surprising turn, the panel first rejected, by a vote of 16-2, boosters for nearly everyone.
Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups. Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population--namely, those most at risk from the virus.
While the Biden administration had set a public goal of enacting a booster program for all U.S. adults this fall, there has been consistent pushback from the scientific community over whether the evidence supported the need for such a sweeping policy.
"It's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health, told the New York Times.
\u201cDiscussing the FDA advisory committee's vote soon with @wolfblitzer on @CNNSitRoom.\n\nThey came to a reasonable middle-ground decision. The most important part is acknowledging that high-risk individuals (by age, medical condition, etc) should be able to get the booster shot.\u201d— Leana Wen, M.D. (@Leana Wen, M.D.) 1631915930
Dr. Ashish Jha, the dean of the Brown University School of Public Health, welcomed the panel's position, tweeting Friday that it is "clearly consistent with the evidence and this outcome should never have been in doubt."
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