Fauci slams UK drugs regulator for speedy approval of Pfizer vaccine

US government’s top infectious-disease specialist claims data was not scrutinised

  Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci speaks during an unscheduled briefing after a Coronavirus Task Force meeting at the White House. Photograph: Eric Baradat/AFP via Getty Images

Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci speaks during an unscheduled briefing after a Coronavirus Task Force meeting at the White House. Photograph: Eric Baradat/AFP via Getty Images

 

Anthony Fauci, the US government’s top infectious-disease specialist, slammed the UK’s drug regulator, saying that it rushed to clear the Covid-19 vaccine from Pfizer and BioNTech. The UK watchdog, called the Medicines and Healthcare products Regulatory Agency, said Wednesday that it had approved the Pfizer vaccine. That means the shot will likely be used in Britain before the US and the European Union. “They’re great, they’re good scientists,” Dr Fauci said in an interview with CBS News, according to a transcript. “But they just took the data from the Pfizer company and instead of scrutinizing it really, really carefully they said, ‘OK, let’s approve it. That’s it.’”

The comments, which he later toned down in a separate appearance, come as Britain’s business minister Alok Sharma indicated the UK would receive an initial batch of 800,000 vaccines but hoped for millions.

“We are starting initially with 800,000 and then let’s see where we end up by the end of the year in terms of the numbers that we acquire. That will depend on the manufacturing,” Mr Sharma said on Sky News.

“I hope we will have some millions by the end of this year but of course what we also always said is that the vast majority of this vaccination programme will take place in the new year,” he said.

The UK’s speedy approval has sparked international debate with some members of prime minister Boris Johnson’s governing Conservative Party crediting Brexit while other officials said the departure from the European Union played no role.

UK education secretary Gavin Williamson said on Thursday that the expedited process didn’t surprise him because the UK is a “much better country.” “We’ve got the very best people in this country and we’ve obviously got the best medical regulator, much better than the French have, much better than the Belgians have, much better than the Americans have,” he said in a radio interview. The US Food and Drug Administration has been under fire from US president Donald Trump because no Covid vaccines were approved before the election in which he was defeated by President-elect Joe Biden.

FDA Commissioner Stephen Hahn and other health officials have said that a careful, transparent approval process is key to ensuring public trust in the vaccine that will be required for a successful immunisation campaign.

The UK “kind of ran around the corner of the marathon and joined it in the last mile,” Dr Fauci told CBS. “They really rushed through that approval.” Fauci later eased off his criticism. “Our process is one that takes more time than it takes in the UK,” Dr Fauci told the BBC, according to a report in the Washington Post. “That’s just the reality. I did not mean to imply any sloppiness even though it came out that way.”

The UK Department for Health and Social Care tweeted a clip late on Thursday of MHRA chief executive June Raine defending the regulator’s methods by saying a “rolling review” process had enabled it to act quickly to approve the vaccine. “A rolling review can be used to complete the assessment of a promising medicine or a vaccine in a situation where time is of the essence, in the shortest time possible,” she said. “But, and this is a very important point indeed, that doesn’t mean that any corners have been cut. None, at all.” - Bloomberg/Reuters