Fauci: UK vaccine approval ‘much less deep’ than US – but jab is ‘safe’

The White House’s chief immunologist has told Sky News he believes the British approval of the Pfizer COVID vaccine has been done in a “much less deep” way than would have been done in the US.

Dr Anthony Fauci told Sky News he believed the data “clearly shows that the vaccine is safe and effective” but that the speed in which it had been passed by the UK health regulator would have prompted scepticism in the US about its safety.

On Wednesday the UK became the first country in the world to approve the Pfizer/BioNTechCOVID vaccine.

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In full: Fauci questions UK’s vaccine approval process

Dr Fauci told Dermot Murnaghan his comments about its testing in the UK were not meant as “a criticism”, but he said: “I think it’s very important for people to realise there are different levels of stringency and scrutiny when you look at the data.

“The FDA in the United States, I think, everyone realises globally is the gold standard of regulatory function.

“Here in the United States, as I’m sure is somewhat in the UK, there is this degree of scepticism on the part of the people about wanting to take a vaccine, thinking that perhaps it was done too quickly, perhaps it isn’t as safe and effective as we say they are.

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“So we put the data through a very, very stringent process of literally point-by-point, analysing the data.

“The UK has decided to do it a little bit differently, they’ve gone over it very quickly.

“And I can say – and this is not a criticism, but they’ve done it in a way that is much less deep than has been done, and is being done by the FDA in the United States.”

An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Pfizer and German partner BioNTech, on November 17, 2020. (Photo by JUSTIN TALLIS / AFP) (Photo by JUSTIN TALLIS/AFP via Getty Images)
Image:Britain’s health regulator said the Pfizer vaccine had been ‘rigorously assessed’

However, following Dr Fauci’s comments, UK health regulator, the Medicines and Healthcare Regulatory Agency (MHRA), doubled down on its commitment to the vaccine’s safety.

A spokesperson said all related data had been “rigorously assessed” and “in the shortest time possible, without compromising the thoroughness” of the review.

The statement added that the data had included results from lab work and from clinical trials in humans as well as manufacturing and quality controls, product sampling, and testing of the final product.

It concluded: “This process is designed to make sure that any vaccine approved meets the expected high standards of safety, quality and effectiveness. No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met. ” 

And Dr June Raine, its chief executive, said simply: “The public’s safety has always been at the forefront of our minds – safety is our watchword.”

Earlier Professor Stephen Evans, who worked on vaccines for the previous incarnation of the MHRA said he thought criticisms of the speed with which the UK approved the first coronavirus vaccine were “mistaken”.

He added: “I suspect Dr Fauci doesn’t necessarily know all the details of the MHRA procedures. I respect him enormously…. but he is not a regulator, he is a researcher… His criticism, I don’t think, has a great deal of validity.”

Mark Gibson

Graduates in Northwestern University, Evanston, Illinois 1990. Move to Los Angeles California in 2004. Specialized in Internet journalism.

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