UPDATED 4:07 P.M.
(Reuters) -A panel of expert outside advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.
The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.
The White House earlier on Friday said it was ready to roll out boosters https://www.reuters.com/world/us/us-ready-roll-out-boosters-pending-fda-cdc-approval-surgeon-general-2021-09-17 of the Pfizer/BioNTech vaccine next week if health officials approve them. But Friday’s vote if followed by the FDA would represent a more modest rollout of booster shots than outlined by the Biden administration, which called for their widespread use six months after people received their first round of shots.
Panel members rejected Pfizer’s request for full approval for booster shots for those aged 16 and older. Instead, the advisory panel’s recommendation was for an emergency use authorization for the narrower group.
Panel members unanimously approved the recommendation for a third dose for older Americans, and were convinced by evidence showing these individuals were at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots.
The FDA will take the panel’s recommendation into consideration in making its final decision on the boosters.
(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)
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(Reuters) -A panel of expert outside advisers to the U.S. Food and Drug Administration voted against broadly approving COVID-19 vaccine booster shots, but may vote on a narrower approval for older adults later on Friday.
The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.
But there was widespread support among panelists for a third dose for older Americans, who are at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots. FDA officials said that a vote to recommend approval for such groups was possible later on Friday.
The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc’s controversial Alzheimer’s drug
Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA was incomplete and that the request for approval for people as young 16 is too broad. Most of them said they were not needed yet for younger adults.
Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.
If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.
The White House said it was ready to roll out boosters next week if health officials approve the plan.
(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)
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