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"We are a much better country": Gavin Williamson throws himself into the Brexit vaccine series with an explosion in the EU


Donald Trump's best medic tonight launched a violent and bitter attack on the UK for the world's leading approval of a coronavirus vaccine to treat millions of people.

Dr. Anthony Fauci accused the UK Medicines Agency of failing to adequately review manufacturers' data before becoming the first country to clear the Pfizer / BioNTech engraving for widespread use.

The American scientist, under pressure from the Trump administration to explain why the United States was beaten by Britain, compared the Medicines and Health Products Regulator (MHRA) to a marathon runner cheating by "doing the last mile "connects.

Both the EU and the United States have struggled after news that the UK will begin rolling out the US / German drug to millions of vulnerable people next week. The first deliveries are made within a few hours.

They asked safety questions about the speed at which the MHRA approved treatment, and Dr. Fauci told CBS News, "I love the British, they're great, they're good scientists, but they just took the data from the Pfizer company and instead of really, really carefully scrutinizing it, they said," OK, let's do it approve, that's it. " "And they went with me".

His allegation was strongly denied by the MRHA today. A spokesman said she had "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.

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."

The UK's Covid-19 death toll passed the grim milestone of 60,000 today after health officials announced another 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.

Among the critics was the US Covid Commander in Chief Anthony Fauci, who warned: "If you act quickly and superficially, people will not want to be vaccinated."

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 approved by the UK Medicines and Health Products Regulatory Agency (MHRA) within just 10 days of receiving the results from the late-stage studies.

The MHRA's decision was made by a number of bodies before it was followed 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 advisors.

America's best coronavirus doctor has criticized the UK for this, claiming 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. "

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 finding 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.

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;

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."

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;

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 best coronavirus doctor has criticized the UK for this, claiming 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. "

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.

"Ich habe sie in den Meetings gesehen und sie stellt die schwierigen Fragen. Wenn es um Sicherheit geht, wird sie eine eiserne Faust in einem Samthandschuh sein. “

Ihr Mann, den sie in Oxford kennengelernt hatte, starb 1995 im Alter von 46 Jahren an Darmkrebs, nachdem sie zwei Kinder zusammen hatten.

Im Jahr 2006 wurde Raine Leiterin der Abteilung für Wachsamkeit und Risikomanagement von Arzneimitteln der MHRA, in der sie für die Verschärfung der Dosierungsempfehlungen für Paracetamol für Kinder verantwortlich war und eine Warnung vor Opioiden herausgab.

Die US-Vorwürfe des Eckschneidens beziehen sich jedoch auf Dr. Anthony Faucis Behauptung, dass Großbritannien die Daten von Pfizer akzeptiert habe, ohne sie erneut zu analysieren.

Sowohl die MHRA als auch die EMA akzeptieren normalerweise Herstellerdaten, wenn sie Genehmigungen erteilen, während die FDA immer alle von einem Unternehmen eingereichten Tabellen reproduziert, indem sie die Daten erneut analysiert.

Die FDA hat für den 10. Dezember ein Treffen geplant, um die Zulassung des Pfizer-Impfstoffs zu erwägen.

US-ANSPRÜCHE, ROHDATEN WIEDER ZU ANALYSIEREN, UND beschuldigen Großbritannien, diese nicht sorgfältig gescreutinisiert zu haben

Experten sagen jedoch, dass die Unterschiede zwischen dem britischen und dem US-amerikanischen Ansatz letztendlich vernachlässigbar sind.

Stephen Evans, Professor für Pharmakoepidemiologie an der London School of Hygiene & Tropical Medicine, sagte: „Dr. Fauci war und ist ein äußerst guter Wissenschaftler, und sein Rat war während dieser Pandemie von sehr hoher Qualität.

'Ich denke jedoch, dass es möglich ist, dass er Bedenken hinsichtlich des britischen Bewertungsverfahrens für den Pfizer / BioNTech-Impfstoff übertrieben hat.

'Die von der FDA und der MHRA durchgeführten Prozesse sind grundsätzlich sehr ähnlich. Der einzige wesentliche Unterschied besteht darin, dass die FDA alle von einem Unternehmen eingereichten Tabellen reproduzieren kann, indem sie die Daten erneut analysiert.

Dies war ein bemerkenswerter Unterschied zwischen der FDA und anderen Aufsichtsbehörden auf der ganzen Welt. Praktisch keine andere Regulierungsbehörde analysiert regelmäßig die Rohdaten, um die von einem Unternehmen durchgeführte Analyse zu überprüfen.

'Wir wissen nicht, wie oft es wesentliche Unterschiede zwischen einer FDA-Analyse und einer Unternehmensanalyse gibt. Wir können durchaus Unterschiede in der Interpretation der Daten zwischen einer Aufsichtsbehörde und einem Unternehmen feststellen, aber diese Art von Unterschied wird regelmäßig von allen Aufsichtsbehörden festgestellt, unabhängig davon, ob sie die Daten erneut analysieren oder nicht. & # 39;

DER MHRA-GENEHMIGUNGSPROZESS

Die MHRA stellte ein Team von mehreren Dutzend Wissenschaftlern, Klinikern und Statistikern zusammen, das von zwei oder drei leitenden Gutachtern geleitet wurde.

Sie untersuchten die Ergebnisse früher Laborarbeiten sowie klinischer Studien und des Herstellungsprozesses.

Die MHRA sagte, ihre Teams hätten "akribisch" mehr als 1.000 Seiten mit Daten zur Qualität, Wirksamkeit und Sicherheit des Impfstoffs durchgesehen.

Sobald die Experten mit den Daten zufrieden waren, musste das Gremium seine Ergebnisse Dr. Raine vorlegen, der den endgültigen Stempel der Genehmigung gab.

Die MHRA wandte sich dann an die Kommission für Humanarzneimittel, eine unabhängige Expertengruppe.

Die Kommission bewertete die Daten erneut, bevor sie der Regierung mitteilte, dass sie sicher sind, und die Notfalllizenz ausstellte.

Quellen der MHRA teilten MailOnline mit, dass die Behörde die Rohdaten aus Pfizers Studien in diesem Fall überprüft habe, um die Befürchtungen hinsichtlich der Sicherheit des Impfstoffs zu zerstreuen. In einer später von der Agentur herausgegebenen Erklärung wurde jedoch nicht erwähnt, dass die Daten wie von Dr. Fauci erwähnt neu tabelliert wurden.

EU-NATIONEN WARTEN AUF ZENTRALREGLER, UM PUTIN UND ORBAN IN DER BUCHT ZU HALTEN

Die Unterschiede zwischen Großbritannien und der EU sind politischer. Die EMA gibt an, dass die Zulassung der Pfizer-Impfstoffe länger andauert, und die EU-Staaten haben sich informell darauf geeinigt, sie nicht zu umgehen, indem sie dieselben Notfallgenehmigungsbefugnisse anwenden, die das Vereinigte Königreich verwendet hat.

Andere Mitgliedstaaten könnten ebenfalls den EMA-Prozess im Rahmen des EU-Notstandsgesetzes umgehen, haben jedoch von der EU-Kommission, die heute behauptet, dies würde das Vertrauen der Öffentlichkeit in Covid-19-Impfstoffe untergraben, "sehr vorsichtig" vorzugehen.

Die Staats- und Regierungschefs in Brüssel wollen ein blockweites Impfprogramm und befürchten, dass eine Nation, wenn sie aus der Reihe tritt, Ungarn dazu ermutigen könnte, die Genehmigung des umstrittenen russischen Impfstoffs Sputnik V zu erzwingen, den es trotz der weit verbreiteten Kritik von EU-Staats- und Regierungschefs und Wissenschaftlern aus Mangel erprobt von öffentlich verfügbaren Daten auf dem Stich.

Die EMA sagt, dass ihr Genehmigungsverfahren strenger ist und mehr Beweise vorlegen muss als die vorübergehende Genehmigung durch die MHRA, eine Behauptung, die von britischen Beamten stark widerlegt wurde.

Guido Rasi, der frühere Leiter der EMA, sagte gegenüber einem italienischen Radiosender, der britische Wachhund habe "nur die Teildaten" ausgewertet und hinzugefügt: "Persönlich hätte ich eine solide Überprüfung aller verfügbaren Daten erwartet, was die britische Regierung nicht getan hat."

Es ist richtig, dass die beiden Notfallgenehmigungen unterschiedlich sind – die MHRA muss jede Charge des Impfstoffs bei der Abgabe genehmigen, und die technische Genehmigung kann jederzeit gestrichen werden, während die Notfallgenehmigung der EMA ein ganzes Jahr vor der Erneuerung gültig ist.

Professor Jonathan Van Tam: Wenn Sie ein Regulierer sind, der etwas zurückliegt, was sagen Sie, um Ihre Position zu rechtfertigen? Wörter wie die, die Sie vielleicht gehört haben. "

An official statement from the MHRA today claimed the body had streamlined its operation 'in a way that allows some stages of this (approval) process to happen in parallel to condense the time needed, but it does not mean steps and the expected standards of safety, quality and effectiveness have been bypassed'.

The MHRA has faced criticism in the past for being 'a black box, an organisation that hasn’t always followed the highest standards of transparent, reproducible science – they do the basics well, but if you don’t do things openly you can put public trust at risk,' one expert told the Guardian.

Fauci

Emer Cooke, head of the EMA

America's top coronavirus doctor Anthony Fauci (left) has criticised the UK for and claimed the MHRA '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.' Emer Cooke, head of the EMA (right)

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

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

BREXIT HAS 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.

But the MHRA, EMA and FDA all kept Pfizer's vaccine under a 'rolling review', allowing officials to scrutinise data from the studies in real time. All three regulators started this process in October and were fed the data at the same time.

Professor Evans claimed the UK regulator was able to move faster than its counterparts abroad because it had more scientific manpower thanks to a Brexit quirk.

He said: 'What is a unique situation is that the UK, while being governed by the EU regulatory laws and decisions, has not been carrying out assessment work for new vaccines or medicines intended for the whole EU for about 18 months.

'The work that would usually be done by the MHRA for Europe, is being shared out by the other 27 member states. Consequently, the UK has almost undoubtedly had greater capacity to respond to a new application for authorization of a vaccine than any other country.

'This temporary situation will change from January 1, 2021 when the UK MHRA becomes responsible for doing all applications for new drugs and vaccines to be authorised in the UK. It will have to do work that previously would have been shared among all the other 28 member states.'

'The work that would usually be done by the MHRA for Europe, is being shared out by the other 27 member states. Consequently, the UK has almost undoubtedly had greater capacity to respond to a new application for authorization of a vaccine than any other country.

The MHRA used to do a lot of the EU's drug regulation work and the EMA was headquarter in London until Brexit, when it relocated to Amsterdam.

Professor Jonathan Van-Tam chimed into the international row about the jab's approval this morning, accusing regulators abroad of lashing out because they are 'behind'. During a round of interviews this morning he said: 'If you’re a regulator who is slightly behind, what do you say to justify your position. Words such as the ones you’ve heard perhaps.’

Dr Fauci, who is under pressure from the Trump administration to explain why the US was beaten by Britain, likened the MHRA to a marathon runner who cheats by joining 'in the last mile'.

He accused the UK drug regulator of failing to adequately scrutinize data from manufacturers before becoming the first country in the world to approve the Pfizer/BioNTech jab.

Dr Fauci telling CBS News: 'I love the Brits, they're great, they're good scientists, 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.'' And they went with it'.

His accusation was denied by the MRHA today, with a spokesman saying it 'rigorously assessed the data in the shortest time possible, without compromising the thoroughness of our review'.

Gavin Williamson mocked Europe and the United States this morning as he insisted that Britain beat them to rolling out a coronavirus vaccine 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 across countries', adding: 'This is not a football competition, we are talking about the life and health of people.'

Explaining the differences in approval processes between the UK and US, Professor Evans said: 'The processes carried out by the FDA and the MHRA are basically very similar.

'The only major difference is that the FDA may reproduce all the tables submitted by a company by re-analysing the data.

'This has been a notable difference between the FDA and other regulatory authorities around the world. Virtually no other regulator will regularly reanalyse from raw data to verify the analysis carried out by a company. We do not know how often there are substantive differences between an FDA analysis and a company analysis.

'We may well see differences in interpretation of the data between a regulator and a company, but this type of difference is regularly seen by all regulators, whether they reanalyse the data or not.

'It is very clear that the UK assessment of this has followed all the usual processes, but has been working incredibly long hours and seven days a week both with MHRA staff and with their academic advisors for quite a long time on initial and interim data before the final data were submitted.

'It is entirely possible that had this pandemic occurred in a year’s time when the MHRA was fully or more than fully occupied with work for the UK, then the speed with which they would have been able to authorise a new vaccine would have been longer than others rather than shorter.

'It will be important to have some evidence that the UK assessment process was deficient in some regard and I think that is very unlikely. In my judgement the assessment of this new vaccine will have been done more rigorously currently then a routine assessment in a non-pandemic situation.

'There is a spotlight on this whole process and if it were to be the case that a problem appears with the vaccine that had been missed by the MHRA and its advisors, then their reputation would be damaged very severely so the incentive to get it right now is very high. It is easy to say the speed means not careful, but it is also possible to understand other reasons for the speed than lack of care.

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