Thursday, March 31, 2022

FDA brags about its massive systems of data collection, learns nothing from them?

FDA had its VRBPAC vaccine advisory committee meeting on October 26, 2021 to obtain its agreement to issue an EUA for 5-11 year olds.  The slides below came from FDA employee Dr. Wong's presentation:

Below, Dr. Wong misdirected 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. In other words, her claim was made on the basis of year old data.

Preauthorization data excludes all the information that has accrued since the vaccines were authorized and entered widespread use.  

Or, it is possible that she was talking about preauthorization data from adolescents, about 1100 of whom received the Pfizer vaccine.  1100 is too small a number to tease out whether these rare diagnoses occur more often in the vaccinated. Which was noted by the members of the VRBPAC at their October 26 meeting, which can still be watched on the FDA website.

Whatever preauthorization trial her data it came from, it was too small to quantify adverse reaction  rates.  All the Pfizer trials were unblinded after 2 months, much too quickly to get reliable safety and efficacy data.

FDA has long claimed it has an extensive collection of healthcare data sets that it continuously studies to make assessments of safety and efficacy.  Imagine this massive collection of data, and what you or I could do with it to determine (probably) everything we needed to know about COVID vaccines.  FDA has data on moe than 100 million Americans.

For example, the 4 medical claims databases below collect data on over 20 million children.

So, here we are in the information age.  Taxpayers are paying for massive collections of data on themselves, sold to federal agencies.  And then the data fall into a black hole, never to be heard from again.  FDA must know the story these data tell, but we do not.

Why do we put up with this, and what can we do to shine some light on the darkness?

Before FDA authorizes vaccines for kids as young as six months old, which could occur as early as this week, don't we deserve to see what the vaccine is doing to older kids?

1 comment:

Anonymous said...

'The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?'