US FDA panel rejects broad use of Pfizer coronavirus boosters in blow to Biden plan
- Advisers to the Food and Drug Administration voted overwhelmingly against third shots for those age 16 and up, despite plans for a roll-out as soon as next week
- There was, however, unanimous support for boosters for older Americans and high-risk patients
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.
Panel members, however, 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 panel also recommended that the FDA include health care workers and others at high risk of occupational exposure to the virus that causes Covid-19, such as teachers.
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WHO says no need for Covid-19 booster shots for now since vaccine supplies are low
The White House earlier on Friday said it was ready to roll out boosters 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 roll-out 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.
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.
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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 US Centres for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.
