America’s top infectious disease expert has rowed back from a suggestion that the U.K. approved a COVID-19 vaccine too quickly.
Dr. Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, claimed American regulators “would do a more thorough job” of assessing the vaccine developed by Pfizer/BioNTech.
He told CBS News that Britain “kind of ran around the corner of the marathon and joined it in the last mile,” adding: “They really rushed through that approval.”
Fauci said: “The FDA, the United States of America Food and Drug Administration, is the gold standard of regulation. They are doing it in a careful way, appropriately.”
He warned that the speed at which the U.K. has approved the Pfizer vaccine could undermine confidence in the shot, telling Sky News: “When we did a survey here in the U.S., there was a considerable degree of skepticism and reluctance to get vaccinated and we were concerned that if we did anything that looked like it was cutting corners that would feed into the scepticism.”
But in a later interview with BBC News, Fauci said he did not mean to “imply any sloppiness,” adding: “I do have great faith in both the scientific community and the regulatory community at the U.K.”
He said there was “no judgement on the way the U.K. did it.”
Fauci told the BBC: “Our process is one that takes more time than it takes in the UK. And that’s just the reality. I did not mean to imply any sloppiness even though it came out that way.”
The comments came as the coronavirus death toll in the U.K. passed the 60,000 mark, jumping to 60,113 on Thursday.
The World Health Organization (WHO) offered a toned-down response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision, simply stating the approval had been “acknowledged.”
In response to the comments, the MHRA said in a statement: “We have rigorously assessed the data in the shortest time possible, without compromising the thoroughness of our review.
“COVID-19 vaccines, including this one, are being developed in a co-ordinated in a way that allows 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.”
It added that a rolling review of the vaccine data started at the beginning of October, and since then the data, and had made good progress on the review before the last submission of data was received.
“Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency.
“No vaccine would be authorized for supply in the U.K. unless the expected standards of safety, quality and efficacy are met,” the statement concluded.
Dr. Siddhartha Sankar Datta, WHO regional adviser for vaccine-preventable diseases and immunization in Europe, said: “The national regulatory authority of a country will review the different elements of a system before they make the vaccine licensed for use – (based on) the safety, efficacy and quality of the vaccine.
“That is what the U.K.’s national regulatory authority has done yesterday with their evaluation. We have learned about it and we acknowledge it.”
Despite this criticism, a Cabinet minister declared the U.K. is getting a coronavirus vaccine first because it is a “much better country” than France, Belgium and the U.S.
Education secretary Gavin Williamson praised the work done by the medical regulator to approve the Pfizer/BioNTech vaccine for use.
The first doses of the vaccine are now believed to have arrived in the U.K.
The UK has ordered 40 million doses of the Pfizer jab, enough to vaccinate 20 million people, with 800,000 doses expected to arrive by next week.