FDA advisers just limited authorisation of Pfizer booster jab to over-65s and vulnerable

FDA advisers just limited authorisation of Pfizer booster jab to over-65s and vulnerable

A committee of independent advisers for the Food and Drugs Administration has voted in favour of authorising a booster dose of Pfizer/BioNTech after rejecting Pfizer’s applications to distribute booster shots to the wider population. The panel has unanimously embraced the alternate plan to offer booster shots to older Americans and other vulnerable people at risk of severe illness, at least six month after completion of the primary two doses.

The panel’s recommendation comes as President Joe Biden’s administration has said it wants to begin offering booster shots to the general public as early as next week. 

The administration cited three CDC studies that showed the protection of the vaccine waned over several months.

Health officials said they were concerned that hospitalisation and death rates would increase as a result of diminished protection. 

The administration said it was particularly concerned about individuals at higher risk of infection, or those inoculated during the earlier phases of the vaccine rollout. 

READ MORE: Covid deaths spike as pending changes to international travel loom: ‘Unexpected challenge’

Doctor Ofer Levy, a vaccine and infectious disease specialist at Boston’s Children’s Hospital, said: “It’s likely beneficial in my opinion for the elderly, and may eventually be indicated for the general population. 

“I just don’t think we’re there yet in terms of the data.”

Although the FDA is not bound by the recommendation, it is unlikely to reject the panel’s advise. 

The meeting was held days after a group of leading researchers suggested vaccine protection against severe Covid persists despite protection against mild disease waning over time. 


The result were expected after two senior FDA officials involved in the meeting said they weren’t convinced every American who received the Pfizer vaccine needed a third dose of the jab. 

Members of the panel cited a lack of safety data on extra doses for individuals in that age group. 

Other advisors highlighted the risk of myocarditis in younger people, arguing that further research was needed.

Other members argued that the third dose should be limited to individuals over the age of 60 who are at risk of severe disease. 

The Center on the Disease Control and Prevention has called for a meeting to further discuss plans the third shots in the US next week.

Infectious diseases expert Doctor Anthony Fauci, said he wasn’t surprised the panel voted against vaccination for people 16 and older.

He explained: “I don’t want to get ahead of the advisory committee at the time that they’re deliberating.” 

The committee was asked to listen to listen to several presentations on data supporting the wide distribution of booster shots before casting a vote. 

A recent study made public by the FDA on Wednesday showed that a third dose of the vaccine could restore protection from infection to 95 percent.

The Israeli study drew on data collected between July 1 and August 30, when rates of the delta variant skyrocketed. 

In a presentation, Doctor Sharon Elroy-Preiss, of Israel’s Health Ministry, said the nation began administering booster at the end of July in a bid to appease pressure on the nation’s hospitals.

She said: “We were able to dampen that effect and our severe cases are roughly 700 or less and have stayed stable, even though we still have days at 10,000 confirmed cases.”

Published at Sat, 18 Sep 2021 10:39:00 +0000

This story originally posted here

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