12-11-2020, 07:29 PM
https://www.nytimes.com/2020/12/11/healt...d=tw-share
Well, the FDA gave the EUA.
I think this is pretty pathetic by Hahn. Imagine that an FDA reviewer, looking through the batch records, finds unacceptable levels of a contaminant in one of the batches that is authorized for release or that examining the stability logs they figure out that degradation is faster than reported and as a result the first few million doses are lower than expected and produce a sub-efficacious response and consequently are wasted.
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials. And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA. I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong. The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.
BC
Well, the FDA gave the EUA.
Quote:The action followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.
I think this is pretty pathetic by Hahn. Imagine that an FDA reviewer, looking through the batch records, finds unacceptable levels of a contaminant in one of the batches that is authorized for release or that examining the stability logs they figure out that degradation is faster than reported and as a result the first few million doses are lower than expected and produce a sub-efficacious response and consequently are wasted.
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials. And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA. I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong. The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.
BC