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Dr. Anthony Fauci apologizes after accusing the UK of breaking approval


Donald Trump's Best Paramedic Dr. Anthony Fauci today apologized for his blistering and bitter attack on Britain for its world's first approval of a Coronavirus vaccination Treating millions of people from Monday.

Dr. Fauci has pulled out of the diplomatic battle after accusing the UK Medicines Agency of failing to adequately review manufacturers' data before becoming the first country to clear the Pfizer / BioNTech sting for widespread use.

The American scientist, under pressure from the Trump administration to explain why the US was beaten by the UK to approve a US-made vaccine, compared the London Medicines and Health Products Regulator (MHRA) to a marathon runner who cheating by joining. in the last mile & # 39 ;.

And he raised safety questions about the speed with which the MHRA approved the treatment, telling CBS News, "I love the British, they're great, they're good scientists, but they just took data from Pfizer and Company instead of really, really carefully questioning it, they said, "OK, let's approve, this is it."

But after a flurry of anger from the UK, where critics accused him of supporting anti-Vaxxer, Mr Fauci later clarified his remarks, saying, “I did not mean to imply sloppiness on the part of UK regulators, even though this came out in this way, I apologize me, adding that there was no judgment on how Britain did it. It came out wrong & # 39 ;.

The EU and US have argued after news that the UK will begin rolling out the US / German drug to millions of vulnerable people next week. The first deliveries arrived last night.

Education Secretary Gavin Williamson mocked her when he insisted that Britain beat her to introduce a coronavirus vaccine because it was simply "a much better country". Dr. June Raine, head of the UK Medicines Agency, said the vaccine review "didn't cut corners".

Britain ordered 40 million doses of Pfizer's vaccine with the expectation to vaccinate 10 million people by the end of the year. That number is now likely to be closer to five million, with shocks starting at 7 a.m. on Monday.

U.S. Covid Supremo Anthony Fauci, pictured with President Trump, has argued over the speed of the UK's decision to approve the Pfizer / BioNTech push, pointing out that they were cheating. He later apologized

Pfizer has now started shipping its coronavirus vaccine to the UK after UK regulator MHRA gave the go-ahead yesterday (Image: A refrigerator truck is photographed as it leaves a Pfizer factory in Puurs, Belgium yesterday).

Pfizer has now started shipping its coronavirus vaccine to the UK after UK regulator MHRA gave the go-ahead yesterday (Image: A refrigerator truck is photographed as it leaves a Pfizer factory in Puurs, Belgium yesterday).

There were 2,804 deaths recorded yesterday, well above the previous record of 2,603 ​​reported on April 15 during the first peak of the pandemic. Previously, John Hopkins University had reported a staggering 3,157 deaths, but revised the death toll this morning after a mistake in reporting from Nevada

There were 2,804 deaths recorded yesterday, well above the previous record of 2,603 ​​reported on April 15 during the first peak of the pandemic. Previously, John Hopkins University had reported a staggering 3,157 deaths, but revised the death toll this morning after a mistake in reporting from Nevada

How did the UK become the first country in the world to approve the Covid vaccine?

The UK was able to convince the US and Europe to approve Pfizer's coronavirus vaccine first, thanks to political issues on the continent and because UK regulators had a larger scientific workforce, experts claim.

The breakthrough was given the green light by the UK Medicines and Health Products Regulatory Authority (MHRA) within just 10 days of receiving the results from the late-stage studies.

The MHRA's decision went through a number of committees before it was given by Dr. June Raine – a career government scientist who has worked in drug regulatory affairs since 1985 – and was appointed to a commission of government scientific advisers.

America's top coronavirus doctor has criticized the UK for this, claiming that the MHRA "just took the data from the Pfizer company and instead of really, really carefully examining it, they said," OK, let's approve it, that's it . "

And EU states have also made corner cutting allegations after agreeing not to use the emergency and using the same permits the UK used to bypass Brussels and give the Pfizer vaccine the go-ahead give. Instead, the member states are waiting for the EU regulator EMA to issue a stricter approval that takes a year.

All three agencies have carried out ongoing reviews of the data provided by Pfizer. The reviews began at the same time, but some scholars claim the UK was more "organized" and proactive in seeking additional data from Pfizer.

However, the U.S. allegations of corner cutting relate to Dr. Anthony Fauci's claim that the UK accepted Pfizer's data without re-analyzing it.

Both the MHRA and EMA usually accept manufacturer data when granting approvals, while the FDA always reproduces all tables submitted by a company by re-analyzing the data.

The FDA has scheduled a meeting on December 10th to consider approving the Pfizer vaccine.

Dr. Fauci started the series after saying, “We want to walk you through the process, this is the standard process. We're hurrying up a little, but not nearly as fast as you are in the UK. We believe if we had done this here in the US it would have been to our disadvantage because it would have generated a lot of skepticism about the speed at which it was approved. & # 39; In another interview with Sky News he suggested that an acceleration of the approval process could lead to an existing “vaccine skepticism”.

The MRHA pushed back heavily, with a spokesman saying it "rigorously assessed the data in no time without compromising the thoroughness of our review".

Ministers and academics gathered around the regulator today amid the attacks from those who finished second, accusing them of being jealous of the UK's speed in approving the new vaccine.

In response, European Commission spokesman Eric Mamer said, "We are definitely not in the game of comparing regulators between countries" adding, "This is not a football competition, we are talking about people's lives and health."

Hopes for vaccine rollout around the world were hit hard tonight as Pfizer can only ship half as many doses of its coronavirus vaccine as it had promised by the end of the year and will reduce its planned global rollout from 100 million to 50 million Million cans.

The company had to roll back its plan due to slowdowns in its supply chain. "The scaling of the raw material supply chain took longer than expected," a company spokeswoman told the Wall Street Journal.

The UK Covid-19 death toll passed the grim milestone of 60,000 yesterday after health officials announced an additional 414 deaths.

However, the government plans to begin its largest vaccination campaign in history next week when the first 800,000 shots eventually hit NHS hospitals and makeshift centers.

The outbreak of Dr. Fauci came on the day the U.S. recorded the highest daily death toll from the pandemic. 2,804 deaths were recorded yesterday, a sharp increase from the previous record of 2,603 ​​on April 15 during the first peak of the pandemic.

They are initially stored in three specially equipped laboratories in order to carry out batch tests.

The operation to transport the Covid-19 vaccine across the border is being kept "top secret" as it is feared that criminal gangs could "intercept and damage" the precious cargo.

Government sources told MailOnline there was a "massive risk" that the first batch of cans could be targeted in a fleet of unmarked trucks en route from a Belgian manufacturing facility to the UK via the Eurotunnel.

Dr. Fauci, director of the National Institute for Allergies and Infectious Diseases, said the US Food and Drug Administration (FDA) is the "gold standard of regulation."

"They do it appropriately and very carefully," Fauci said of the FDA's process for approving a vaccine.

"Because if we've done anything that has compromised – we have enough problems with people being skeptical about taking a vaccine – if we'd jumped the hurdle here quickly and inappropriately, an extra week or a week and a half." to win I think that the credibility of our regulatory process would have been damaged. & # 39;

He said a poll of Americans showed "a considerable amount of skepticism and reluctance to vaccinate."

But British scientists hit back. An MHRA spokeswoman said: “We have rigorously assessed the data in no time without compromising the thoroughness of our review.

'This includes scientists and clinicians who have carefully and scientifically reviewed the safety, quality and efficacy data – how it protects people from COVID-19 and what level of protection it offers.

& # 39; The data included results from laboratory and human clinical studies; Manufacturing and quality control, product sampling and testing of the final product. The purpose of this process is to ensure that each approved vaccine meets the expected high standards of safety, quality and effectiveness.

"No vaccine would be approved for delivery in the UK if the expected standards of safety, quality and efficacy were not met."

Dr. Fauci later appeared to be trying to smooth things over, telling Sky News, "I don't want to criticize who is right or wrong, it's just a different level of control."

Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, added: “Dr. Fauci was and is an extremely good scientist, and his advice has been of a very high quality during this pandemic.

However, & # 39; I think it is possible that he exaggerated concerns about the UK review process for the Pfizer / BioNTech vaccine.

& # 39; The processes carried out by the FDA and the MHRA are fundamentally very similar. The only major difference is that the FDA can reproduce all tables submitted by a company by re-analyzing the data.

'This was a notable difference between the FDA and other regulatory agencies around the world.

“Virtually no other regulator will regularly re-analyze raw data to verify the analysis that a company has carried out.

& # 39; We don't know how often there are significant differences between an FDA analysis and a company analysis. We can certainly find differences in the interpretation of the data between a regulator and a company, but this type of difference is regularly noticed by all regulators, whether they re-analyze the data or not. & # 39;

Dr. Fauci said the United States is expected to approve the Pfizer vaccine for "emergency approval" on December 11, followed by the Moderna product by December 18.

He said, “So we don't see it as a race of who won, the product is there, the test was done, the data looked really good, pretty effective and I think pretty safe and it's just a matter of the type of The supervisory authority in each country checks the data. & # 39;

Exciting Education Secretary Williamson made an amazing broadside against the US and the EU in an interview this morning.

As he appeared on LBC Radio, Williamson said, “Well, I just think we have the best people in this country and we obviously have the best medical regulator, much better than the French, much better than the Belgians. much better than the Americans.

"That doesn't surprise me at all, because we are a much better country than any of them."

He was assisted by assistant chief medical officer Jonathan Van-Tam, who suggested that critics were jealous of the speed at which Britain was moving.

He told BBC Breakfast, “If you are a regulator who is a little further behind, what do you say to justify your position that you are further behind? Words like the ones you may have heard. «

When the Minister was criticized, Downing Street defended his comments. The Prime Minister's official spokesman said he was stressing "his pride in Britain".

The spokesman added: "I think you saw that the Secretary of State is rightly proud of the UK."

Deputy Chief Medical Officer Jonathan Van-Tam suggested that UK critics were jealous of the speed at which the UK had moved

Deputy Chief Medical Officer Jonathan Van-Tam suggested that UK critics were jealous of the speed at which the UK had moved

The full list of hospitals where Pfizer puffs are being delivered to the first UK recipients was released last night when the UK military was running dry runs for the country's largest mass vaccination

The full list of hospitals where Pfizer puffs are being delivered to the first UK recipients was released last night when the UK military was running dry runs for the country's largest mass vaccination

Officials hope that Oxford's Covid vaccine could be approved before Christmas

The UK could start using Oxford University's coronavirus before Christmas if approved by drug regulators in a decision that could be made next week.

The MHRA became the first agency in the world this week to clear a Covid-19 vaccine for public use when it approved a vaccine made by Pfizer and BioNTech.

The sting developed by Oxford and AstraZeneca following instructions from the Ministry of Health on November 27 is currently being evaluated. Scientists behind the sting have already submitted the final test results to a medical journal that is expected to be published shortly.

Professor Jonathan Van-Tam, assistant chief physician for England, said the batch – of which No. 10 has ordered 100 million cans – will "hopefully be approved before Christmas".

It took regulators eight working days to approve Pfizer's vaccine after the Department of Health officially requested to evaluate it. If AstraZenecas can be carried out in the same period, a decision could be announced as early as Tuesday next week, December 8th.

The push is likely to be operational within a few days when it is finally approved. It is made in England and is easy to transport as it can be stored in regular refrigerators or even at room temperature.

The other of the three promising vaccines from the US company Moderna is a step back in the approval process, but will not be available in the UK until March 2021 at the earliest.

Ministers sought to buy seven million doses of the vaccine from Moderna after the company announced that clinical studies showed 94.5 percent effectiveness.

The MHRA – Regulatory Authority for Medicines and Health Products – has not yet been officially mandated to start the assessment.

Professor Van-Tam confirmed that the UK's first shipment – leaving Pfizer's Belgian manufacturing facility in trucks last night – will arrive "shortly". The UK's biggest vaccination campaign of all time starts next week.

Ministers faced an international backlash after several, including Health Secretary Matt Hancock, claimed separation from the EU and less bureaucracy meant Britain defeated the rest of the world to approve the new coronavirus vaccine.

European figures opposed the idea, as did the MHRA, which said the approval was done using provisions of European law that will still be binding on the UK until the end of the transition period in January.

MHRA chief June Raine said it was still bound by EU law through the end of the year, and "our progress was entirely dependent on the availability of data in our ongoing review and the independent advice we received".

Mr Williamson, urged today by moderator Nick Ferrari to make it clearer whether Brexit helped, added, “I think it just means dealing with things, delivering them and the brilliant people in ours medical regulatory agency to enable the people of this country to be the first in the western world to get this Pfizer, in the world to get this Pfizer vaccine.

“Real competitive advantage, but do you know who is important? It's up to these brilliant, brilliant clinicians in the regulator who made it happen so quickly. So we want to express our gratitude to them because if they want them to, they will have saved lives. & # 39;

But wise member Jeremy Farrer, the director of the Wellcome Trust, responded to his claims.

"Vaccine nationalism has no place in COVID or any other public health issue of global concern. Science has always been the exit strategy from this terrible pandemic – that science was global and needed an unprecedented global partnership and funding," he tweeted.

& # 39; Interventions, vaccines, diagnostics and public health treatments are now available because of these partnerships.

“Each and every one comes about through cross-border work. Vaccines made possible through science and the support of so many. No country could have supplied these vaccines. & # 39;

Dr. Fauci, the highly respected American expert who repeatedly clashed with Donald Trump, used an interview with Fox News to question the UK's approach.

"If you go fast and do it superficially, people won't want to be vaccinated," he said.

We have the gold standard regulatory approach with the FDA (Food and Drug Administration). & # 39;

"Britain has not done it that carefully," he added. “You have a few days ahead of you. I don't think that makes that much of a difference. & # 39;

Downing Street struck back this afternoon and a spokesman said, “I want to trace you back to what Dr. June Raine said yesterday where she clearly set out the strict procedures that were followed to approve the vaccine.

"She said herself that no corners had been cut and I would point out what she and her medical colleagues said again."

Commons chairman Jacob Rees-Mogg called the approval of the Pfizer / BioNTech vaccine a "British success" and accused the European regulator of being "a bit astute".

The Minister of Education attacked the United States, France and Belgium in a radio interview this morning in an astonishing broadside manner

The Minister of Education attacked the United States, France and Belgium in a radio interview this morning in an astonishing broadside manner

Matt Hancock (pictured today on Downing Street) said yesterday that Europeans are "moving a little slower" due to the additional red tape - but stressed that the Pfizer BioNTech bump had gone through intense security checks.

Matt Hancock (pictured today on Downing Street) said yesterday that Europeans are "moving a little slower" due to the additional red tape – but stressed that the Pfizer BioNTech bump had gone through intense security checks.

Gavin Williamson: The tarantula-owning ex-boss whip who is no stranger to controversy

Gavin Williamson first gained political notoriety in July 2016 when he was named Theresa May's chief whip.

He first made headlines for his Cronus tarantula, which he kept in a box on his desk in the House of Commons, while trying to enforce Conservative Party discipline.

However, his promotion to Secretary of Defense in November 2017 made much more headlines when, to the surprise of many at Westminster, he took on the role of governing cabinet.

But due to the 44-year-old's inexperience and inclination to gaffs, the newcomer quickly referred to Private Pike as "Private Pike" – after the character of the unfortunate young father's army.

The MP for South Staffordshire – Ms. May's campaign manager in her successful 2016 leadership offer – quickly became known for the tendency to put his foot in his mouth.

At the height of the excitement over the Novichok attack in Salisbury in March 2018, Williamson urged Russia to "go away and shut up" – which mocked critics.

In December last year, he was accused of pursuing policies "that belong on a Netflix series" after saying that Islamist fighters should be hunted down and killed.

During his tenure as Secretary of Defense, he was also at the center of a row of cabinets after accused of offending the Chinese and canceling an important trade visit by Chancellor Philip Hammond to Beijing.

On this occasion, the then Defense Minister had given a speech a few days before the mission, in which he spoke of sending a warship of the Royal Navy into the sensitive waters of the Indo-Pacific. These words did not go down well in Beijing.

Mr Williamson was fired by Ms. May in May 2019 after allegedly losing information from a National Security Council on whether Huawei would play a role in building the UK's 5G network.

Mr. Williamson, who is married with two children, has emphatically denied any involvement in the leak.

He returned to the back benches and assisted Boris Johnson during the ensuing battle for Tory leadership, playing a key role on the future Prime Minister's campaign team.

Mr. Williamson was rewarded with a return to the Cabinet when Mr. Johnson appointed him Secretary of Education.

But the coronavirus crisis has seen Mr Williamson in hot water several times.

He had promised that elementary schools would fully reopen before the summer break in England but had to abandon plans after school principals said social distancing rules made the move impossible.

Meanwhile, he has been accused of botching the introduction of a free school lunch voucher program while his Department of Education failed to meet a target for giving out laptops to disadvantaged students.

He told MPs: "Britain should really be proud that our regulator came first and we find that the European regulator is a bit astute, wish we hadn't, and that Germany, France and others are European Countries seek refuge. " I didn't manage to do the same.

“We have, we lead, drawn your own conclusions as I am sure the UK public will.

“We are now free from the dead hand of the European Union and on January 1st we will be even freer from it.

"It is a great British achievement that we should be proud and delighted of."

The World Health Organization (WHO) has "recognized" the UK's decision to approve a Covid-19 vaccine developed by Pfizer and Biotech for mass use.

Dr. Siddhartha Sankar Datta, WHO regional advisor on vaccine-preventable diseases and vaccinations in Europe, said:

He said: “The use of vaccines in the UK – for all vaccines for children and for vaccines for children outside of childhood – has been going on for several decades.

“For several decades, the UK regulator has made decisions about the use of the vaccine in a country based on the vaccine's properties for safety, efficacy and quality.

“Using a vaccine, or getting a vaccine approved for use in any country, is very routine by regulators in every country in the world, including the UK.

“Having taken note of the UK National Regulatory Authority's decision, WHO () is also in contact with European Medicines Agencies and the UK Authority to understand the decision-making process.

"The decision-making process was also shared with the public and health professionals on the various modalities that were assessed. The final decision was made yesterday by the UK regulator."

It comes amid growing confusion over # 10's priority list after counselors insisted that nursing home residents would be at the top of the queue, but the need to freeze the shocks deep, up to 95 percent according to clinical studies being effective means they cannot be brought home and the residents at risk are not currently allowed to leave.

The vaccine, which requires two doses three weeks apart, is supplied in packs of 975 to 4,875 doses in 1.5 ml vials of five doses each.

However, the MHRA, which regulates the safety of drugs and vaccines, has not yet given permission to split them up into smaller batches.

Many nursing homes only have dozens of residents, which means that even the smallest package contains way too many doses and wastes hundreds of valuable puffs.

And it now turns out that NHS health workers, who officially rank second for the vaccine, are unlikely to receive it until Christmas to protect limited supplies. NHS sources told the Health Service Journal that small numbers of health workers are expected in areas with lower public demand this year.

Yesterday the Minister of Health said that Europeans are "moving a little slower" because of the additional bureaucracy – but stressed that the Pfizer BioNTech push, which will be launched next week, has still undergone intensive security checks.

German MEP Pieter Liese weighed in to insist that individual EU member states could have approved the vaccine but decided to wait for the European Medicines Agency (EMA) to review more information rather than the "hasty" example Britain's to follow.

The European regulator has criticized the approval of the vaccine with the help of emergency personnel, insisting that a separate, slower approach is more appropriate.

Meanwhile, Berlin's ambassador to Britain issued a sharp retort after Economy Secretary Alok Sharma said history will remember the "Britain-led indictment of mankind against this disease".

Andreas Michaelis pointed out that BioNTech was a German company and added: "Why is it so difficult to recognize this important step forward as a great international effort and success?"

Berlin's ambassador to Britain issued a sharp retort after Economy Secretary Alok Sharma said history will remember "Britain-led indictment of mankind against this disease".

Berlin's ambassador to Britain issued a sharp retort after Economy Secretary Alok Sharma said history will remember "Britain-led indictment of mankind against this disease".

The UK Medicines and Health Products Regulatory Authority (MHRA) said the Pfizer vaccine (pictured) was approved using provisions of European law

The UK Medicines and Health Products Regulatory Authority (MHRA) said the Pfizer vaccine (pictured) was approved using provisions of European law

At a press conference, MHRA boss Dr. June Raine (picture): "We were able to authorize the delivery of this vaccine according to the provisions of European law, which will last until January 1st."

At a press conference, MHRA boss Dr. June Raine (picture): "We were able to authorize the delivery of this vaccine according to the provisions of European law, which will last until January 1st."

Mr Hancock opened the series in a round of interviews yesterday morning, telling Times Radio, “The reason we have been moving so fast and Britain is the first country in the world to have a clinically approved vaccine, the reason is twofold.

“Firstly, this is the first reason because the MRHA has worked extremely well with the company to look at this data as it comes in and do things in parallel rather than one at a time, as usual.

& # 39; The second reason is that until we were in the European Medicines Agency (EMA) earlier this year, due to Brexit, we were able to make a decision based on the UK regulator which is a world class regulator to do. and not walking at the pace of Europeans who move a little slower.

"We are performing the same security reviews and processes, but the Brexit means we have been able to speed up the process."

Mr Liese, who sits on the European Parliament's Public Health Committee and is a member of Angela Merkel's CDU party, said: “I think this decision is problematic and I recommend that EU Member States not repeat the process in the same way.

"A few weeks of thorough EMA scrutiny is better than rushing to get a vaccine approved."

He suggested the move may have been influenced by Prime Minister Boris Johnson's internal troubles.

The UK now has nearly 60,000 corona deaths. On top of that, Britain is an island and has never been a Schengen member, which means open borders in Europe, ”he said.

"Great Britain should compare itself more to countries like New Zealand or Ireland, which have the infection rate much better under control."

The EMA suggested carrying out stricter controls than the emergency procedure used by the MHRA.

A spokeswoman said: "The MHRA's temporary approval of the vaccine is not a marketing authorization.

"It differs from the marketing authorizations in the number of evidence submitted and the controls required."

The EMA believes that the Conditional Marketing Authorization (CMA) process is "the most appropriate regulatory mechanism for use in the current pandemic emergency".

A CMA application is supported by "large amounts of data" submitted by businesses and "provides a controlled and robust framework".

BioNTech is a German company and the ministers' attempts to portray the approval as a British success story have been criticized by the Berlin government.

Downing Street stopped to support Mr Hancock's claim about Brexit.

The Prime Minister's official spokesman said: "It is clear that we are the first country in the world to approve this vaccine and it is incredibly positive news that we can start spreading it."

How Great Britain won the vaccination race: EU countries are being held back by politics, American scientists are taking more time to analyze raw data and Brexit has temporarily left Great Britain with more workers

The UK was able to convince the US and Europe to approve Pfizer's coronavirus vaccine first, thanks to political issues on the continent and because UK regulators had a larger scientific workforce, experts claim.

The breakthrough was given the green light by the UK Medicines and Health Products Regulatory Authority (MHRA) within just 10 days of receiving the results from the late-stage studies.

The MHRA's decision went through a number of committees before it was given by Dr. June Raine – a career government scientist who has worked in drug regulatory affairs since 1985 – and was appointed to a commission of government scientific advisers.

America's top coronavirus doctor has criticized the UK for this, claiming that the MHRA "just took the data from the Pfizer company and instead of really, really carefully examining it, they said," OK, let's approve it, that's it . "

And EU states have also made corner cutting allegations after agreeing not to use the emergency and using the same permits the UK used to bypass Brussels and give the Pfizer vaccine the go-ahead give. Instead, the member states are waiting for the EU regulator EMA to issue a stricter approval that takes a year.

All three agencies have carried out ongoing reviews of the data provided by Pfizer. The reviews began at the same time, but some scholars claim the UK was more "organized" and proactive in seeking additional data from Pfizer.

The MHRA's decision was made in a number of bodies before it was followed by Dr. June Raine, a government government scientist who has worked in drug approval since 1985

The MHRA's decision was made in a number of bodies before it was followed by Dr. June Raine, a government government scientist who has worked in drug approval since 1985

THE SCIENTIST OF THE & # 39; STEELY & # 39; CAREER GOVERNMENT WHO FINALLY SAID ABOUT JAB

Dr. June Raine graduated from Oxford and joined the Public Service Science Department in 1985 where she has worked in drug regulatory and public health since then.

She was appointed head of the MHRA in September 2019 after a 35-year career in the public service.

A colleague told the Guardian about her: “She is careful, polite and caring.

“But her whole life has been devoted to public health, and she has a certain strength in defending that cause.

“I've seen her in meetings and she asks the tough questions. If there are safety issues, she will be an iron fist in a velvet glove. & # 39;

Her husband, whom she met in Oxford, died of colon cancer in 1995 at the age of 46 after they had two children together.

In 2006, Raine became head of the MHRA's drug vigilance and risk management department, where she was responsible for tightening paracetamol dosage recommendations for children and issuing a warning against opioids.

However, the U.S. allegations of corner cutting relate to Dr. Anthony Fauci's claim that the UK accepted Pfizer's data without re-analyzing it.

Both the MHRA and EMA usually accept manufacturer data when granting approvals, while the FDA always reproduces all tables submitted by a company by re-analyzing the data.

The FDA has scheduled a meeting on December 10th to consider approving the Pfizer vaccine.

US CLAIMS TO RE-ANALYZE RAW DATA AND accuse the UK of not having carefully screened them

However, experts say the differences between the UK and US approaches are ultimately negligible.

Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “Dr. Fauci was and is an extremely good scientist, and his advice has been of a very high quality during this pandemic.

However, & # 39; I think it is possible that he exaggerated concerns about the UK review process for the Pfizer / BioNTech vaccine.

& # 39; The processes carried out by the FDA and the MHRA are fundamentally very similar. The only major difference is that the FDA can reproduce all tables submitted by a company by re-analyzing the data.

This was a notable difference between the FDA and other regulatory agencies around the world. Virtually no other regulator regularly analyzes the raw data to validate the analysis carried out by a company.

& # 39; We don't know how often there are significant differences between an FDA analysis and a company analysis. We can certainly find differences in the interpretation of the data between a regulator and a company, but this type of difference is regularly noticed by all regulators, whether they re-analyze the data or not. & # 39;

THE MHRA APPROVAL PROCESS

The MHRA assembled a team of several dozen scientists, clinicians, and statisticians led by two or three senior reviewers.

They examined the results of early laboratory work as well as clinical studies and the manufacturing process.

The MHRA said their teams "meticulously" reviewed more than 1,000 pages of data on the quality, effectiveness and safety of the vaccine.

Once the experts were satisfied with the data, the panel had to share its findings with Dr. Show Raine, who gave the final stamp of approval.

The MHRA then turned to the Commission for Medicinal Products for Human Use, an independent group of experts.

The commission reassessed the data before notifying the government that it is safe and issuing the emergency license.

MHRA sources told MailOnline that the agency had reviewed the raw data from Pfizer's studies in this case to allay concerns about the safety of the vaccine. However, a statement later issued by the agency made no mention that the data was as reported by Dr. Fauci mentioned were re-tabulated.

EU NATIONS ARE WAITING FOR CENTRAL CONTROLLERS TO KEEP PUTIN AND ORBAN IN THE BAY

The differences between the UK and the EU are more political. The EMA states that Pfizer vaccines are taking longer to approve, and EU states have informally agreed not to bypass them by using the same emergency authorization powers that the UK has used.

Other member states could also bypass the EMA process under the EU Emergency Act, but have been "very cautious" of the EU Commission, which claims today that this would undermine public confidence in Covid-19 vaccines.

Heads of state and government in Brussels want a bloc-wide vaccination program and fear that if a nation steps out of line, it could encourage Hungary to force approval of the controversial Russian vaccine Sputnik V, which it has received despite widespread criticism from the EU – Heads of state or government and academics for lack of tried of publicly available data on the prick.

The EMA says its approval process is stricter and must provide more evidence than the MHRA's temporary approval, a claim that has been heavily refuted by UK officials.

Guido Rasi, the former head of the EMA, told an Italian radio station that the British watchdog had evaluated "only the partial data" and added: "Personally, I would have expected a solid review of all available data, which the British government has not done."

It is correct that the two emergency approvals are different – the MHRA must approve each batch of the vaccine as it is dispensed, and the technical approval can be withdrawn at any time, while the EMA emergency approval is valid for a full year before renewal.

Professor Jonathan Van Tam: If you are a lagging regulator, what do you say to justify your position? Words like the ones you may have heard. & # 39;

In an official statement from the MHRA today, it was claimed that the agency has streamlined its operations so that some phases of this (approval) process can run in parallel in order to reduce the time required. However, this does not mean any steps and the expected safety standards, quality and effectiveness have been bypassed ”.

The MHRA has been criticized in the past for being a black box, an organization that doesn't always follow the highest standards of transparent, reproducible science – it does the basics well, but if you don't do things openly, you can say it publicly Trust at risk, ”an expert told the Guardian.

Fauci

Emer Cooke, Head of EMA

America's top coronavirus doctor Anthony Fauci (left) has criticized the UK for this, claiming that the MHRA only took the data from the Pfizer company and instead of really, really carefully examining it, they said, “OK, let's approve it that was & # 39; s. & # 39; Emer Cooke, Head of EMA (right)

The breakthrough was given the green light by the MHRA within just 10 days of receiving the results of their late-stage trials. A truck leaves the factory in Belgium where the Covid vaccine is manufactured

The breakthrough was given the green light by the MHRA within just 10 days of receiving the results of their late-stage trials. A truck leaves the factory in Belgium where the Covid vaccine is manufactured

BREXIT LEFT MHRA WITH MORE SCIENTIFIC MANPOWER

It usually takes months, if not years, for regulators to review data from vaccine studies and determine whether they are safe, effective, and whether the studies are of a high standard.

However, the MHRA, EMA, and FDA have put Pfizer's vaccine on "rolling reviews" so officials can review the data from the trials in real time. All three regulators started this process in October and received the data at the same time.

Professor Evans claimed that the UK regulator can move faster than its counterparts overseas due to a Brexit quirk that it has a larger scientific workforce.

He said: “A unique situation is that, although the UK is subject to EU laws and decisions, it has not been doing any EU-wide evaluation of new vaccines or medicines for about 18 months.

“The work that is normally done by MHRA for Europe is shared by the other 27 Member States. As a result, the UK undoubtedly had more capacity than any other country to respond to a new application for approval of a vaccine.

& # 39; This temporary situation will change from January 1st, 2021 when the UK MHRA will be responsible for all applications for approval of new drugs and vaccines in the UK. It will have to do work that would previously have been shared by all the other 28 Member States. "

“The work that is normally done by MHRA for Europe is shared by the other 27 Member States. As a result, the UK undoubtedly had more capacity than any other country to respond to a new application for approval of a vaccine.

The MHRA used to do much of the EU's drug regulation work, and the EMA was headquartered in London until Brexit when it moved to Amsterdam.

Professor Jonathan Van-Tam interfered in the international dispute over the approval of the sting this morning, accusing overseas regulators of fighting for being "back". During a round of interviews this morning he said, “If you are a lagging regulator, what do you say to justify your position? Words like the ones you may have heard. & # 39;

Dr. Fauci, who is under pressure from the Trump administration to explain why the US has been beaten by Britain, compared the MHRA to a marathon runner cheating by joining "on the last mile".

He accused the UK Medicines Agency of failing to adequately review manufacturers' data before becoming the first country in the world to approve the Pfizer / BioNTech sting.

Dr. Fauci told CBS News, "I love the British, they are great, they are good scientists, but they just took the data from the Pfizer company and instead of really, really carefully examining it, they said," OK, let's go approve it, that's it. «» And they participated «.

His allegation was dismissed today by the MRHA. A spokesman said she had "rigorously assessed the data in no time without compromising the thoroughness of our review."

Gavin Williamson mocked Europe and the United States this morning when he insisted that Britain beat them to get a coronavirus vaccine on the market because it was simply "a much better country".

In response, European Commission spokesman Eric Mamer said, "We are definitely not in the game of comparing regulators between countries" adding, "This is not a football competition, we are talking about people's lives and health."

Professor Evans explained the differences in approval processes between the UK and the US as follows: “The processes used by the FDA and MHRA are fundamentally very similar.

& # 39; The only major difference is that the FDA can reproduce any tables submitted by a company by re-analyzing the data.

'This was a notable difference between the FDA and other regulatory agencies around the world. Virtually no other regulator regularly analyzes the raw data to validate the analysis carried out by a company. We don't know how often there are significant differences between an FDA analysis and a company analysis.

“We can certainly see differences in how a regulator and an organization interpret the data, but this type of difference is regularly noticed by all regulators, whether they re-analyze the data or not.

& # 39; It is very clear that the UK Assessment has followed all normal processes in this regard, but has been working on initial and preliminary data for an incredibly long time, seven days a week, with both MHRA staff and their academic advisors final data has been submitted.

“It is entirely possible that if this pandemic had occurred in a year that the MHRA was fully or more than fully engaged in work for the UK, the speed at which it could have approved a new vaccine would have been longer than others rather than shorter.

“It will be important to have evidence that the UK evaluation process has been flawed in some ways and I think this is very unlikely. In my opinion, the evaluation of this new vaccine has now been carried out more rigorously than a routine evaluation in a non-pandemic situation.

“This whole process is at the center, and if there is a problem with the vaccine that has been overlooked by the MHRA and its advisors, its reputation is very badly damaged so the incentive to get it right now is very high. It is easy to say that speed is not careful, but it is also possible to understand speed reasons other than lack of care.

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