PENDING POST, incomplete

VDA had its advisory meeting on October 26, 2021 to obtain its agreement to issue an EUA for the 5-11 year olds.  The slides below came from Dr. Wong’s talk 

Below, Dr. Wong misdirects the audience by showing a list of most of the dreaded possible complications of COVID vaccines, and says they were actually not associated with COVID vaccine… in preauthorization data. Preauthorization data were collected up until November 14, 2020 from the approximately 40,000 enrollees in Pfizer’s adult trial.  Preauthorization data excludes all the information that has accrued since the vaccines were athorized and entered widespread use.  She might have been talking about preauthorization data from adolescents, about 1100 of whom received the Pfizer vaccine.  1100 is too small a number to tease out these diagnoses.  Whetever preauthorization trial data it came from, it was too small, to assess reactin rates.  The trials was unblinded after 2 months, much too quickly to get reliable safety and efficacy data.

The vaccine had been authorized in adults for over 10 months at the time of the meeting, and those were the data that would have been most germane to analysing vaccine use in the 5-11 year olds.

FDA has long claimed it has an extensive collection of health data sets that can assist in calculations of safety and efficaccy.


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