White House coronavirus advisor Dr Anthony Fauci took back his criticism of UK’s authorisation of Pfizer’s COVID-19 vaccine. The UK has become the first country to authorise a vaccine for the deadly coronavirus. Fauci, on December 3, called review by of the vaccine by British regulators, “much less deep” than it would have been if done by the US Food and Drug Administration. Fauci, who has been approached by President-elect Joe Biden to head the COVID-19 task force, said that he had faith in the quality of work by British regulators. UK PM Boris Johnson on Wednesday announced that Medicines and Healthcare products Regulatory Agency (MHRA) had assessed data for the vaccine Pfizer developed in association with BioNtech.
“There really has been a misunderstanding, and for that I’m sorry, and I apologise for that,” Fauci told Reuters.
“The UK has decided to do it a little bit differently, they’ve gone over it very quickly,” he had said earlier. “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,” adding that FDA reviews are a “very, very stringent process.”
In being the first country to authorise the vaccine, Britain has gained a jumpstart to begin mass inoculation against the virus that has claimed more than 1.5 million lives. EU and US regulators in the meantime are sifting through the same data and are yet to give their approval. “If we had, for example, approved it yesterday or tomorrow, there likely would have been pushback on an already scrutinising society,” Fauci told Reuters. “You know, at the end of the day, it's going to be safe, it's going to be effective, the people in the UK are going to receive it and they're going to do really well, and the people in the United States are going to receive it and we're going to do pretty well,” he added.
The UK was able to review data in realtime until there was enough evidence to support a formal authorisation as Pfizer had been submitting data to the UK on a rolling basis.
In response to Fauci’s criticism, MHRA said, they had “rigorously assessed the data in the shortest time possible without compromising the thoroughness of our review”.
The agency also said its emergency approval had allowed “some stages of this process to happen in parallel to condense the time needed, but it does not mean steps and the expected standards of safety, quality and effectiveness have been bypassed”.
