Britain is at the centre of a major international row over how fast it has approved a coronavirus vaccine – which Australia has also committed to buy – as senior figures mocked other countries for being slow.
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 Medicines and Healthcare Products Regulatory Agency (MHRA) acted to approve the treatment.
But the excitable Education Secretary fired an astonishing broadside back at them in a radio interview this morning.
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’.
The Morrison government has 10million doses of the vaccine on order but the drug – which Australia’s Therapeutic Goods Administration has put on a fast-tracked path to approval – is still waiting for the green light from health regulators to be used Down Under.
Health Minister Greg Hunt said on Wednesday evening the announcement was an important step for the world – but added Australians should not expect to have access to the Pfizer vaccine any earlier than March of next year.
Australia has deals to get hold of four vaccine candidates and will roll out doses to the vulnerable and priority workers early next year if they are approved by regulators.
Appearing on the UK’s 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 all because we’re a much better country than every single one of them.’
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)
He was backed by deputy chief medical officer Jonathan Van-Tam, who suggested critics 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.’
As the minister faced criticism, Downing Street defended his comments.
The Prime Minister’s official spokesman said he was ’emphasising his pride in the UK’, adding: ‘I think what you have seen is the Secretary of State rightly being proud of the United Kingdom.’
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.
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’
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.’
This afternoon Downing Street hit back, with a spokesman saying: ‘I would point you back to what Dr June Raine said yesterday where she clearly set out the rigorous processes that had been followed in order to authorise the vaccine.
‘She said herself no corners had been cut and again I would point you back to what her and her medical colleagues said.’
The Education Secretary lashed out at the US, France and Belgium in an astonishing broadside in a radio interview this morning
The World Health Organisation (WHO) said it has ‘acknowledged’ the UK’s decision to approve a Covid-19 vaccine developed by Pfizer and Biotech for mass use.
Dr Siddhartha Sankar Datta, WHO regional adviser for vaccine-preventable diseases and immunisation in Europe, said:
He said: ‘The use of vaccine in the UK – for all childhood vaccine and non-childhood vaccine – is ongoing for several decades now.
‘The regulatory authority in the UK has been making the decision on use of the vaccine in a country, based on the vaccine characteristics for safety, efficacy and quality, for several decades now.
‘The process of using a vaccine, or authorising a vaccine for use in a country, is done very routinely by the regulatory authorities in every country in the globe, including the UK.
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.
‘As we have taken a note of the decision being made by the UK’s national regulatory authority, (the) WHO is also in touch with European medicine agencies, and also the UK’s authority, to understand the decision-making process.
‘The decision-making process was shared also with the general public and also with the healthcare professionals on the different modalities that were being assessed – with the final decision being made by the regulatory authority of the UK yesterday.’
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.
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’
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?’
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 Hancock kicked off the row in a round of interviews yesterday 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.’
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.’
PFIZER’S COVID-19 VACCINE TIMELINE AT A GLANCE
March 17: Pfizer and Germany firm BioNTech announce they are co-developing a Covid-19 vaccine.
The companies team up after previous collaborations on flu jabs.
July 13: Their vaccine is granted fast-track status by the FDA.
It gives regulators in the US the ability to review data from studies into the jab in real time, so it can be approved and rolled out quicker.
July 20: Phase one trial on 12 adults show the vaccine stimulates antibody response.
July 27: Phase two trial is launched in a much larger group of people and compared to a placebo to see if the jab is safe.
August 12: Results from the study of 45 adults find the jab is well tolerated with few side effects and stimulates the immune response thought to be needed to fend off Covid-19 infection.
Mid-August: Phase three trials are launched in the US. These trials see researchers administer the jab then wait to see if people get infected naturally in the community.
September 12: Phase three trials are expanded to include 44,000 people at more than 120 clinical sites across the US, Brazil, South Africa and Argentina.
October 6: The European Medicines Agency agrees to initiate a rolling review, which the FDA had done months earlier.
October 30: The UK Medicines and Healthcare Products Regulatory Agency (MHRA) also undertakes rolling review. It opens the door for the US, UK and Europe to get doses by the end of 2020.
November 9: Early results from phase three suggest nine out of 10 people who get their jab are protected by it.
November 18: The pharmaceutical giant claimed the final results of the trial showed it was safe, 95 per cent effective and works in older people who are most at risk of dying from the disease.
December 2 : The The Medicines and Healthcare products Regulatory Agency approves the jab and Matt Hancock says mass-vaccination will begin from the following week.
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.
A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia
‘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.
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’.
HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.
94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .
95% effective (160 positive in placebo group, 8 positive in vaccine group).
62% – 90% effective, depending on dosing.
Moderna confirmed it will charge countries placing smaller orders, such as the UK’s five million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.
The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.
Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.
UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US.
UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.
UK has already ordered 100million doses and is expected to be first in line to get it once approved.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.
Oxford said there have been no serious safety concerns. Mild side effects have been relatively common in small trials, with many participants reporting that their arm hurt after the jab and they later suffered a headache, exhaustion or muscle pain. More data is being collected.
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.’