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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsFauci criticizes early UK approval of Pfizer/BioNTech vaccine.
UK didnt scrutinize vaccine trial data as carefully as FDADr. Anthony Fauci mentioned British well being regulators didnt scrutinize trial data as carefully as the US Food and Drug Administration earlier than approving the usage of Pfizers coronavirus vaccine, in keeping with a report.
The way the FDA is, our FDA is doing it, is the correct way, Fauci, the director of the National Institute of Allergy and Infectious Diseases, instructed Fox News, according to CNN.
We really scrutinize the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine, Fauci mentioned.
I think if we did any less, we would add to the already existing hesitancy on the part of many people to take the vaccine because theyre concerned about safety or theyre concerned that we went too quickly, he added.
https://us.newschant.com/us-news/uk-didnt-scrutinize-vaccine-trial-data-as-carefully-as-fda/
Klaralven
(7,510 posts)According to one of the Brits interviewed on CNBC or Bloomberg yesterday, they have been receiving data as the trial progressed.
I'm not clear on why we wait until the end of the trial, have the applicants prepare some big report plus the data, and then go through a weeks long analysis by the regulator.
You only have a couple tens of thousands of trial subjects with a couple hundred cases of Covid and likely less than a thousand other medical events during the couple month duration of the trial.
My Pet Orangutan
(9,303 posts)?
Klaralven
(7,510 posts)My Pet Orangutan
(9,303 posts)like the Lancet, the gold standard medical journal, that published the MMR study, linking vaccines with autism, igniting the Anti-vaxxer movement.
Klaralven
(7,510 posts)Scientific and academic peer-reviewed journals publish incorrect and fraudulent papers all the time.
Peer review is not some process guaranteeing correctness. In practice, it consists of sending a version of the paper that has undergone a preliminary review by editors out to a few researchers familiar with the type of subject matter. These "peer reviewers" are busy with their own work, they are not paid, and they are on fairly tight deadlines to submit their review. They will not have the time, resources or raw information to redo any of the analysis for correctness. They certainly won't replicate any experiments. The review is mostly about general reasonableness of the paper and whether the results are important enough to be published in the journal. In particular, will the paper be cited often enough in the future to maintain or increase the journal's impact factor.
My Pet Orangutan
(9,303 posts)like all those years in the '80s saying Mad Cow was no threat to the public. You can't trust the Tories on health, least of all, 'herd immunity' Boris.
Gothmog
(145,562 posts)genxlib
(5,535 posts)I think the aggregate matters.
It is good that UK approved. It will be good when the FDA approves it. It will be better when the WHO, EU, Australia, Canada, etc. approve it.
When multiple independent agencies approve it, my confidence goes up exponentially with each one.
muriel_volestrangler
(101,361 posts)"I have a great deal of confidence in what the UK does both scientifically and from a regulator standpoint," Dr Fauci told the BBC on Thursday.
...
On Thursday, he walked back the comments, and said there was "no judgement on the way the UK did it".
"Our process is one that takes more time than it takes in the UK. And that's just the reality," Dr Fauci told the BBC. "I did not mean to imply any sloppiness even though it came out that way."
https://www.bbc.co.uk/news/world-us-canada-55177948