28 Million Young Vaccine Guinea Pigs, and Counting
This week, a U.S. Food and Drug Administration panel unanimously (with one abstention) approved Pfizer’s COVID vaccine to be given to 5- to 11-year-old children.
In doing so, the FDA betrayed the expanded mission Congress gave it in the early 1960s after the morning sickness drug thalidomide caused thousands of birth defects in newborn infants in over 40 foreign countries (though exactly how thalidomide caused these defects was not fully understood until just a few years ago).
In 1962, because of thalidomide’s devastating impact, Congress added what were known as the “Kefauver Amendments” to the original bill which created the FDA in 1938. In laymen’s terms, the agency’s fundamental focus became (Page 3 at link) “better extremely safe than sorry.” Those amendments’ most critical elements (Page 5 at link) “authorized the FDA to deny a new drug application (NDA) if there was not substantial evidence that the drug would have its claimed effect.”
The FDA panel’s decision completely and indefensibly abandoned the agency’s posture during the past 60 years by approving the use of the vaccine for 28 million children in the 5-11 age group despite the clear lack of legally required “substantial evidence” of safety,
