Thursday 3 December 2020

Dr Fauci apologises for saying UK 'rushed' vaccine

Dr Anthony Fauci, the top US infectious disease expert, has apologised for remarks that seemed to criticise the UK's vaccine approval process.

"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.

The UK on Wednesday became the first country in the world to approve the Pfizer vaccine for the coronavirus.

It has defended the rapid approval and said the jab is safe and effective.

Dr Fauci on Wednesday had told Fox News that the UK did not review the vaccine "as carefully" as US health regulators. He later told CBS News that the UK had "rushed" the approval.

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."

Dr June Raine, the head of the UK medicines regulator, on Wednesday said that "no corners had been cut" in vetting the vaccine. The Medicines and Healthcare Products Regulatory Agency (MHRA) reviewed preliminary data on the vaccine trials dating back to June.

"No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met," the regulator said.

On Thursday, the UK's deputy chief medical officer Prof Jonathan Van-Tam told the BBC he was "very confident" in the MHRA.

He said there was more than "100 years of medical experience" between the UK regulator and the committee advising which groups of people are vaccinated first.

And UK Education Secretary Gavin Williamson attributed the UK's expedited process to the regulator's "brilliant clinicians".

Dr Fauci's remarks come as the US surpasses 14 million total Covid-19 infections, with a recorded 274,648 deaths.

A woman holds her niece while waiting in line at a walk-up Covid-19 testing site on December 2, 2020 in San Fernando, California
Getty Images

The top doctor has said he believed that the US would have vaccine approval soon.

The FDA plans to meet on 10 December to discuss approval for the UK-approved vaccine, which was created through a partnership between Pfizer and BioNTech.

They will meet again on 17 December to discuss a second vaccine - Moderna - request.

Dr Fauci had described the US Food and Drug Administration's approval process, slower than the UK, as the "gold standard". On Thursday he clarified, saying the US does "things a little differently" than the UK.

"That's all," he said. "Not better, not worse, just differently."

Presentational grey line

Analysis by Naomi Grimley, BBC health correspondent

America's Food and Drug Administration does have a different approach to other regulators around the world - it often asks vaccine makers for their raw data, which it then spends time re-analysing.

The UK's medicines regulator in London, on the other hand, relies more heavily on the companies' own reports as does the European Medicines Agency, based in Amsterdam.

Politics may also explain why the FDA hasn't yet given the green light. Back in October, President Trump pressured health officials to approve the first vaccine candidates before election day on 3 November but they pushed back, fearing it might become a political football.

The FDA said it wanted to see two months' extra safety data from the final phase vaccine trials before pharmaceutical companies could apply for emergency approval.

That has inevitably left some arguing the US has got bogged down in a much more detailed review than might have been necessary.

The head of the European Medicines Agency also appeared to raise eyebrows yesterday at the truncated timetable in London.

But officials in the UK believe the US and EU are likely to approve the vaccine soon.

Presentational grey line

The EU, meanwhile, is eyeing a 29 December meeting of the European Medicines Agency to determine if there is adequate safety data on the vaccine for it to be approved in Europe. This timeline puts the EU weeks behind both the UK and US. After the agency approves the vaccine, it will probably also need a sign-off from the EU Commission.

Also on Thursday, Dr Fauci met members of President-elect Joe Biden's team to discuss the incoming administration's response to the pandemic.

Mr Biden later told CNN that he would retain Dr Fauci as chief medical adviser to the new administration's Covid-19 team.

Dr Fauci told CBS earlier that he agreed with Mr Biden that it was "possible" the US might see an additional 250,000 deaths by January.

Dr Fauci has led the US National Institute of Allergy and Infectious Diseases (NIH) for more than 30 years - covering five presidential transitions - and has become the most visible member of the White House's coronavirus task force.

He and Mr Trump have clashed repeatedly since the onset of the pandemic, but Dr Fauci said on Thursday he was never prevented by the White House from speaking his mind.

"There have been bumps along the road," he said of his interactions with the Trump administration.

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December 04, 2020 at 11:48AM

https://www.bbc.co.uk/news/world-us-canada-55177948

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