Kamis, 03 Desember 2020

Dr Fauci: The UK 'was not as careful' as US in vaccine approval - BBC News

Dr Anthony Fauci
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Dr Anthony Fauci, the top US infectious disease expert, has said that the UK was not as rigorous as the US in its Covid-19 vaccine approval process.

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

"The UK did not do it as carefully," he told Fox News. "If you go quickly and you do it superficially, people are not going to want to get vaccinated."

The UK has defended its process, and said the jab is safe and effective.

Dr June Raine, the head of the UK medicines regulator, on Wednesday said that "no corners had been cut" in vetting the jab. 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.

  • Pfizer vaccine judged safe for use in UK next week

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 nears 14 million total Covid-19 infections, with a recorded 273,590 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
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The top doctor has said he believed that the US would have vaccine approval soon, and defended the US Food and Drug Administration (FDA) and its review process.

"The way the FDA is, our FDA is doing it, is the correct way," he said on Fox News. "We really scrutinise the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine."

Speaking to CBS on Thursday, Dr Fauci said again he thought the UK "really rushed through that approval".

"They kind of ran around the corner of the marathon and joined it in the last mile," he said with a laugh. Dr Fauci said he would get the vaccine himself as soon as he can, pending approval, and would be willing to do so on camera to help boost public confidence in the jab.

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.

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 Medicine's 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.

Fauci to aid Biden transition

And also on Thursday, Dr Fauci told CBS News, the BBC's US partner, he will meet with members of President-elect Joe Biden's team to discuss the incoming administration's response to the pandemic. Dr Fauci had already met with Mr Biden's incoming chief-of-staff, he said.

Thursday's meeting will mark his first "substantive" talks with the Biden team Dr Fauci told CBS, and will include discussion of Covid-19 vaccines.

Mr Biden has said that President Donald Trump's initial refusal to engage in the transition process, and to co-ordinate planning for vaccine distribution, could cost American lives.

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

He 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 has clashed repeatedly with Mr Trump since the onset of the pandemic, but said on Thursday that 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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2020-12-03 17:48:00Z
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