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FDA Meeting Re: Pfizer Booster

The scientific advisory committee to the FDA listened to a full day of presentations about the Pfizer vaccine - its vaccine efficacy against infection and its safety.  Data was presented by a scientist from the UK, scientists from Israel, the CDC, FDA, and Pfizer.  The vaccine is still effective against severe infections, hospitalizations, and deaths.  By the end of the day agreement was reached that there was some data demonstrating that vaccine efficacy was waning in older patients with exposure to the delta variant.  When given a 3rd dose their relevant Covid antibodies increased 10-fold. In each of these studies it was still unclear whether vaccine efficacy was waning or the arrival of the delta variant, or a combination of both.   

Safety information was also reviewed in these presentations, and the advisory committee members didn't think they had enough data yet on third boosters in the younger groups of males who are at increased risk of developing myocarditis-pericarditis.  There were no new safety issues, and even though the heart side effect was rare and mild, the committee recommended that the 3rd dose be held until there is more data. Other side effects were very similar to those associated with 2nd doses.  

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The original question to be answered was whether a 3rd dose of the Pfizer vaccine should be given 6 months after dose 2 to people 16 years or older.  That vote didn't pass.  But each member of the committee felt that the 3rd dose should be given to 1.) fully vaccinated people 65+ years old, at least 6 months after dose 2.  2.)  People who were at high risk because of their occupational exposures. This proposal passed unanimously.  Meanwhile more data will be accumulated and analyzed - both to see if the vaccine efficacy is dropping and to make sure that 3rd doses are safe in younger people.  That proposal passed unanimously.

It is so interesting to watch a full day of scientific data presentations and to learn from experts on vaccine efficacy and safety.  I watch every one of these advisory committee meetings and will get my 3rd dose (because I'm 65+) as soon as the CDC advisory committee meets next week to review the data and approve the FDA decision.

 

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