Britain was at the centre of a major international row over the speed at which it approved a coronavirus vaccine today as it mocked other countries for being slow.
Senior figures in both the EU and the United States lashed out after the UK’s regulator approved the Pfizer BioNTech jab, which will begin roll-out to millions of vulnerable people next week in a world first.
They raised safety questions over the speed at which the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) acted to approve the treatment.
Critics included the US Covid supremo Anthony Fauci, who warned: ‘If you go quickly and you do it superficially, people are not going to want to get vaccinated.’
And the European Commission said that its European Medicines Agency (EMA) regulator ‘requires a higher level of evidence to be submitted and checked than a temporary use authorisation’.
But British politicians and scientists hit back, with deputy chief medical officer Jonathan Van-Tam suggesting they were jealous of the speed at which the UK had moved.
He told BBC Breakfast: ‘If you’re a regulator who’s slightly further behind, what do you say to justify your position, that you are further behind? ‘Words such as the ones you’ve heard, perhaps.’
Minister Gavin Williamson also waded into the row, claiming that the UK was simply ‘a much better country’ than its rivals.
The Education Secretary lashed out at the US, France and Belgium in an astonishing broadside in a radio interview this morning.
Appearing on LBC radio, Mr Williamson said: ‘Well I just reckon we’ve got the very best people in this country and we’ve obviously got the best medical regulator, much better than the French have, much better than the Belgians have, much better than the Americans have.
‘That doesn’t surprise me at because we’re a much better country than every single one of them.’
Britain will receive its first batches of Pfizer and BioNTech’s Covid-19 vaccine within hours after the UK yesterday became the first country in the world to approve the jab.
Professor Van-Tam, confirmed Britain’s first shipment — which left Pfizer’s Belgian manufacturing plant in lorries last night — will arrive ‘very shortly’, with the UK’s biggest ever vaccination drive starting next week.
Pfizer has now started shipping its coronavirus vaccine to the UK after the British regulator MHRA gave it the green light yesterday (Pictured: A refrigerated truck is photographed leaving a Pfizer factory in Puurs, Belgium, yesterday)
Deputy chief medical officer Jonathan Van-Tam suggesting the UK’s critics were jealous of the speed at which the UK had moved
The full list of hospitals where Pfizer jabs will be given to the first British recipients were revealed last night as the UK military carried out dry-run drills for the country’s biggest-ever mass vaccination
Has Brexit helped win the vaccine race?
Acting alone has helped the UK authorise the Pfizer BioNTech vaccine before the EU, but it not down to any legal change stemming from the split.
Rather it has been the political decision by Brussels to act together at 27 countries with deliberate caution that has slowed down the bloc, allowing Britain to get there first.
Yesterday the Health Secretary boasted that the Europeans were ‘moving a little bit more slowly’ due to extra red tape that did not apply in the UK any more.
But the MHRA chief June Rise later pointed out it made its decision for Britain under European law, which still binds the UK until the transition period ends in January.
UK officials have been quick to point out that no corners have been cut in approving the jab this week.
But the European Medicines Agency (EMA) has suggested that it is imposing more stringent checks than the emergency process used by the MHRA.
The EMA believes that its conditional marketing authorisation (CMA) process is ‘the most appropriate regulatory mechanism for use in the current pandemic emergency’.
A CMA application is supported by ‘extensive data’ submitted by companies and ‘provides a controlled and robust framework’.
Dr Berkeley Phillips, medical director of Pfizer UK, compared the process to a book, with the necessary chapters written but not yet fully bound into a complete work.
He told reporters: ‘In an emergency situation, the MHRA have effectively said ‘We can see what we need to see from those chapters in this book – the book still needs to be written in totality – but, given the crisis that we’re in, we have seen enough to be confident to give this emergency authorisation’.
Ministers have faced an international backlash after several, including Health Secretary Matt Hancock, claimed the split from the EU and less red tape meant the UK beat the rest of the world to approve the new coronavirus vaccine.
European figures dismissed the idea, as did the MHRA, which said the approval was made using provisions under European law, which still binds the UK until the transition period ends in January.
MHRA chief June Raine said it is still bound by EU law until the end of the year and ‘our progress has been totally dependent on the availability of data in our rolling review and the independent advice we have received’.
Mr Williamson, pressed today by presenter Nick Ferrari to be clearer on the issue of whether Brexit did help, he added: ‘I think just being able to get on with things, deliver it and the brilliant people in our medical regulator making it happen means that people in this country are going to be the first ones in the western world to get that Pfizer, in the world to get that Pfizer vaccine.
‘Real competitive advantage, but do you know who it’s down to? It’s down to those brilliant, brilliant clinicians in the regulator who’s made it happen so fast, so our thanks go out to them because by doing want they’ve done, they’re going to have saved lives.’
But Sage member Jeremy Farrer, the director of the Wellcome Trust, lashed out at his claims.
‘Vaccine nationalism has no place in COVID or other public health matters of global significance. Science has always been the exit strategy from this horrendous pandemic – that science has been global & has needed an unprecedented global partnerships & global financing,’ he tweeted.
‘Public health interventions, vaccines, diagnostics & treatments now starting to be available because of those partnerships.
‘Every single one come about by work across borders. Vaccines made possible by science & support of so many. No country could have delivered these vaccines.’
Dr Fauci, the highly respected American expert who has clashed repeatedly with Donald Trump, used a Fox News interview to question the UK’s approach.
‘If you go quickly and you do it superficially, people are not going to want to get vaccinated,’ he said.’
We have the gold standard of a regulatory approach with the FDA [Food and Drug Administration].’
‘The UK did not do it as carefully,’ he added. ‘They got a couple of days ahead. I don’t think that makes much difference.’
The Education Secretary lashed out at the US, France and Belgium in an astonishing broadside in a radio interview this morning
Matt Hancock (pictured in Downing Street today) boasted yesterday that the Europeans were ‘moving a little bit more slowly’ due to extra red tape – but stressed that the Pfizer BioNTech jab had gone through intense safety checks.
WHY CAN’T PFIZER’S VACCINE BE TAKEN TO CARE HOMES?
Care home residents, as some of the people most vulnerable to Covid-19, were originally expected to be first in line for a coronavirus vaccine when one arrived.
But the Government has conceded the sector will not get priority because the logistics behind transporting the fragile vaccine are ‘formidable’, with care workers and elderly hospital patients likely to first in the queue.
Officials are bound by red tape which means they can’t deliver vials of the vaccine to Britain’s 411,000 care home residents individually.
This is because the Pfizer vaccine comes in packs of 975 doses – and the UK regulator has not yet given permission for these to be split up.
Delivering these full packs to care homes could result in hundreds of precious vials being thrown away. This is because the vaccine must be stored in extremely low temperatures.
Temperature is so important because the vaccine is made with genetic material, which breaks down rapidly in the wrong conditions. Freezing the material – known scientifically as RNA – keeps it stable and ensures the vaccine will work as well as it did in lab trials.
Pfizer and BioNTech will only allow the vaccine to be distributed in trays of 195 vials because this is understood to be the smallest quantity that they have lab-tested to make sure the liquid remains stable during transport.
Each vial contains five doses, and shippers can move, at most, five of these trays at a time. This means it is only provably safe to deliver between 975 and 4,875 doses in one go.
Further tests are ongoing to work out whether the batches can safely be broken down into smaller packages, and to see if it will remain stable at higher temperatures, requiring less strict storage.
Smaller batches would allow the vaccines to be delivered to local centres and care homes but they cannot be used until drugs regulators – the MHRA in Britain – have seen proof that it will not affect how well the jab works.
Sir Simon Stevens admitted last night the mass roll out would begin in hospitals with some NHS staff, patients over 80, care home staff and and some vulnerable people who were already scheduled to come into hospital.
Jonathan Van-Tam, the deputy chief medical officer for England, told a Downing Street press conference last night: ‘As soon as it is legally and technically possible to get the vaccine into care homes, we will do so.
‘But this is a complex product with a very fragile culture. This is not a yoghurt that can be taken out of the fridge and put back in multiple times.’
It comes amid mounting confusion over No10’s priority list after advisers insisted care home residents would be at the front of the queue but the need to deep-freeze the jabs, which clinical trials suggest are up to 95 per cent effective, means they can’t be taken out to homes and the at-risk residents are not currently allowed to leave.
The vaccine — which requires two doses taken three weeks apart — comes in packs of between 975 and 4,875 doses packaged in 1.5ml vials that each have five doses each inside them.
But the MHRA, which regulates the safety of drugs and vaccines, has not yet given permission for these to be split into smaller batches.
Many care homes have only dozens of residents, meaning that even the smallest package would be far too many doses and lay hundreds of precious jabs to waste.
And it has now emerged that NHS health workers, officially second in line for the vaccine, are not likely to get it before Christmas in order to protect the limited supplies. NHS sources told the Health Service Journal that only a small number of health staff are now expected to get the jab this year, in areas where public demand is lower.
Yesterday the Health Secretary boasted that the Europeans were ‘moving a little bit more slowly’ due to extra red tape – but stressed that the Pfizer BioNTech jab that will be rolled out next week had still gone through intense safety checks.
German MEP Pieter Liese weighed in to insist individual EU member states could have authorised the vaccine but had chosen to wait for the European Medicines Agency (EMA) to examine more information rather than follow the ‘hasty’ example of Britain.
The European regulator has criticised the approval of the vaccine using emergency powers, insisting that its own, slower approach is more appropriate.
Meanwhile, Berlin’s ambassador to the UK issued a sharp retort after Business Secretary Alok Sharma said history would remember the ‘UK led humanity’s charge against this disease’.
Andreas Michaelis pointed out that BioNTech was a German firm, adding: ‘Why is it so difficult to recognise this important step forward as a great international effort and success?’
Mr Hancock kicked off the row in a round of interviews this morning, telling Times Radio: ‘The reason we’ve been able to move this fast, and the UK is the first country in the world to have a clinically authorised vaccine, the reason is twofold.
‘Firstly, because the MRHA has done a great job of working with the company to look at that data as it’s come through and do things in parallel, rather than one after the other as they normally would, that’s the first reason.
‘The second reason is because, whilst until earlier this year we were in the European Medicines Agency (EMA), because of Brexit we’ve been able to make a decision to do this based on the UK regulator, a world-class regulator, and not go at the pace of the Europeans, who are moving a little bit more slowly.
‘We do all the same safety checks and the same processes, but we have been able to speed up how they’re done because of Brexit.’
Berlin’s ambassador to the UK issued a sharp retort after Business Secretary Alok Sharma said history would remember the ‘UK led humanity’s charge against this disease’
The UK’s Medicines and healthcare Products Regulatory Agency (MHRA) said saying the approval of the Pfizer vaccine (pictured) was made using provisions under European law
Mr Liese, who sits on the European Parliament’s public health committee and is a member of Angela Merkel’s CDU party, said: ‘I consider this decision to be problematic and recommend that EU member states do not repeat the process in the same way.
‘A few weeks of thorough examination by the EMA is better than a hasty emergency marketing authorisation of a vaccine.’
He suggested that the move could have been influenced by Prime Minister Boris Johnson’s domestic difficulties.
‘Britain now has nearly 60,000 corona deaths. Add to this the fact that Britain is an island and has never been a Schengen member, which means open borders in Europe,’ he said.
‘Britain would have to compare itself more with countries like New Zealand or Ireland, which have a much better grip on the infection rate.’
The EMA suggested that it was imposing more stringent checks than the emergency process used by the MHRA.
At a press briefing, MHRA chief Dr June Raine (pictured) said: ‘We have been able to authorise the supply of this vaccine using provisions under European law which exist until January 1.’
A spokeswoman said ‘The temporary authorisation of the vaccine by the MHRA is not a marketing authorisation.
‘It differs from marketing authorisations in the level of evidence submitted and checks required.’
The EMA believes that the conditional marketing authorisation (CMA) process is ‘the most appropriate regulatory mechanism for use in the current pandemic emergency’.
A CMA application is supported by ‘extensive data’ submitted by companies and ‘provides a controlled and robust framework’.
BioNTech is a German firm and ministers’ attempts to portray the approval as a UK success story were criticised by the Berlin government.
Downing Street stopped short of backing 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 will be able to start to distribute it.’