Babak Belurs

Kamis, 03 Desember 2020

COVID-19: Fauci says UK vaccine approval 'much less deep' than US - but jab is 'safe' - Sky News

The White House's chief immunologist has told Sky News he believes the British approval of the Pfizer COVID vaccine has been done in a "much less deep" way than would have been done in the US.

Dr Anthony Fauci told Sky News he believed the data "clearly shows that the vaccine is safe and effective" but that the speed in which it had been passed by the UK health regulator would have prompted scepticism in the US about its safety.

On Wednesday the UK became the first country in the world to approve the Pfizer/BioNTechCOVID vaccine.

Dr Fauci told Dermot Murnaghan his comments about its testing in the UK were not meant as "a criticism", but he said: "I think it's very important for people to realise there are different levels of stringency and scrutiny when you look at the data.

"The FDA in the United States, I think, everyone realises globally is the gold standard of regulatory function.

"Here in the United States, as I'm sure is somewhat in the UK, there is this degree of scepticism on the part of the people about wanting to take a vaccine, thinking that perhaps it was done too quickly, perhaps it isn't as safe and effective as we say they are.

"So we put the data through a very, very stringent process of literally point-by-point, analysing the data.

"The UK has decided to do it a little bit differently, they've gone over it very quickly.

"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."

Live COVID updates as UK prepares for vaccine rollout

However, following Dr Fauci's comments, UK health regulator, the Medicines and Healthcare Regulatory Agency (MHRA), doubled down on its commitment to the vaccine's safety.

A spokesperson said all related data had been "rigorously assessed" and "in the shortest time possible, without compromising the thoroughness" of the review.

The statement added that the data had included results from lab work and from clinical trials in humans as well as manufacturing and quality controls, product sampling, and testing of the final product.

It concluded: "This process is designed to make sure that any vaccine approved meets the expected high standards of safety, quality and effectiveness.

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

And Dr June Raine, its chief executive, said simply: "The public's safety has always been at the forefront of our minds - safety is our watchword."

Earlier Professor Stephen Evans, who worked on vaccines for the previous incarnation of the MHRA said he thought criticisms of the speed with which the UK approved the first coronavirus vaccine were "mistaken".

He added: "I suspect Dr Fauci doesn't necessarily know all the details of the MHRA procedures.

"I respect him enormous.... but he is not a regulator, he is a researcher… His criticism, I don't think, has a great deal of validity."

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2020-12-03 19:09:18Z
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Avonmouth explosion: Four dead in Bristol water works blast - BBC News

Four people have died and another has been injured after a large explosion at a waste water treatment works.

Firefighters were called to Wessex Water's premises in Avonmouth, Bristol, at about 11:20 GMT.

Three of the people who died worked for the firm, and the other was a contractor. The injured person's condition is not life-threatening.

The blast happened in a silo containing treated biosolids and was not terror related. police said.

A witness reported hearing a "very loud explosion" that "shook buildings", and another said they saw "around 10 ambulances driving to the scene".

Police declared a major incident and are investigating the circumstances of the blast.

Ch Insp Mark Runacres, from Avon and Somerset Police, said the explosion happened in a chemical tank at a water recycling centre.

"The fire service led the rescue operation but sadly, despite the best efforts of all those involved, there were four fatalities.

"This is a tragic incident and our thoughts and sympathies go out to them," he added.

The families of those who died have been contacted.

Luke Gazzard, from Avon Fire and Rescue Service, said the four people died at the scene, and there was no report of a fire.

He said emergency services had dealt with "a very, very challenging incident".

Prime Minister Boris Johnson said in a tweet he was "deeply saddened" to learn that four people had lost their lives in the explosion.

"Our hearts go out to the victims and their families. Thank you to the emergency services who attended the scene."

'Absolutely devastated'

Colin Skellett, chief executive of Wessex Water, said their "thoughts are with the families, friends and colleagues of those involved".

He said they were "absolutely devastated that the tragic incident at our site earlier today has resulted in four fatalities".

The company is working with the Health and Safety Executive as part of the investigation.

The silo holds treated biosolids before it is recycled to land as an organic soil conditioner, Ch Insp Runacres said.

He said a "thorough investigation involving a number of agencies" would be carried out.

"I can reassure people living in the nearby area that there is not believed to be any ongoing public safety concerns."

People have been urged to avoid the area.

Jawad Burhan, who took a photo appearing to show a tank that had exploded, said there was a "helicopter looking for missing people".

"I heard the sound, I'm working beside the building in another warehouse.

"After 10 minutes I saw the helicopter coming and the police," he added.

'Everything was shaking'

Kieran Jenkins, who works nearby, said he was inside a warehouse when he heard a "big bang".

"The whole warehouse was shaking, and we literally stood there in shock because everything was shaking." he said.

"We thought everything was going to fall and we came out and all we could see was people running - it was a bit of a shock, really."

Bristol Waste, which runs the nearby Avonmouth recycling centre, tweeted it had closed the site temporarily.

Lorry driver Ronan Doyle said he was parked off King's Weston Lane about to enter the recycling plant when he heard the explosion.

"There was a quieter "whoosh" first, followed by a much louder and more intense noise," he said.

"It sounded like someone had driven into the lorry - the noise was so loud it didn't sound like anything I've ever heard before and it was followed by a loud bang."

He added: "I continued into the recycling centre and we have just locked ourselves in purely because our way out is blocked."

'Boom and echo'

Sean Nolan, who witnessed the aftermath of the explosion, said he had heard a "boom and echo" but thought it was a crash.

"I heard what I thought may have been two trucks colliding by the way it shook the ground... it was big.

"It was quite short-lived, I'd say about two or three seconds. Sort of a boom and echo and then it just went quiet.

"That was it. There was no smoke, there was no after-effects of it."

Labour leader Sir Keir Starmer gave his condolences on Twitter, writing: "My thoughts are with all those who tragically lost their lives today in Avonmouth. My heart goes out to their friends and family."

Darren Jones, MP for Bristol North West, said: "My family and I are keeping those affected in our thoughts and prayers, following the tragic consequences of the explosion in Avonmouth."

He was "pleased that the situation has been contained and that there is no further risk to local people".

Bristol Mayor Marvin Rees said: "This has already been such a challenging year, and this news of further loss of life is another terrible blow.

"As a city we will mourn for them."

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2020-12-03 18:45:00Z
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Dr Fauci: The UK 'was not as careful' as US in vaccine approval - BBC News

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

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.

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.

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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