12-13-2020, 05:03 PM
Also, thalidomide is a great tale about how a reviewer at the FDA prevented the Agency from approving the drug.
https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey
By holding up the review, Kelsey saved thousands of children from birth defects, as thalidomide was never approved in the US for morning sickness (despite lots of pressure from the drug's manufacturer).
When I say that Steve Hahn should have resigned rather than allow administration pressure to grant the EUA for the Pfizer vaccine, this is what I had in mind. Imagine if reviewers see a safety signal or a batch impurity or manufacturer defect now in a week, after hundreds of thousands have been vaccinated. Confidence in vaccines will be destroyed for a generation.
BC
https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey
By holding up the review, Kelsey saved thousands of children from birth defects, as thalidomide was never approved in the US for morning sickness (despite lots of pressure from the drug's manufacturer).
When I say that Steve Hahn should have resigned rather than allow administration pressure to grant the EUA for the Pfizer vaccine, this is what I had in mind. Imagine if reviewers see a safety signal or a batch impurity or manufacturer defect now in a week, after hundreds of thousands have been vaccinated. Confidence in vaccines will be destroyed for a generation.
BC