Questions are being asked over the speed at which the UK managed to approve the ‘game-changing’ Oxford University/AstraZeneca jab.
Yesterday, Britain became the first and only country to give the go ahead for the use of the vaccine, following rigorous trials which found no-one who was given the jab became seriously ill.
Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said the jab had been under a ‘rolling review’, which sped up its delivery compared to a usually years-long process.
But European scientists are sceptical at how quickly the regulator was able to sign it off for emergency use.
Thomas Senderovitz, director of the Danish Medicines Agency (DMA) said: ‘I am a little afraid that it has gone too fast for the English. I must say.
Questions are being asked over the speed at which the UK managed to approve the ‘game-changing’ Oxford University/AstraZeneca jab. Pictured: A volunteer is administered the coronavirus vaccine, which was given approval yesterday
‘We actually know what data they have been looking at, and here our perception of what is reasonable to approve differs quite markedly at present.
He told Danish newsite DR: ‘However, this does not necessarily mean that it cannot be approved by the European Medicines Agency, EMA, if there are better answers on the table.
‘But right now there is a long way to go.’
Meanwhile, the European Medicines Agency (EMA) said it had not received sufficient data to give the Oxford/AstraZeneca vaccine a conditional authorisation, adding that even a January approval date was unlikely.
The Food and Drug Administration (FDA) in the US said approval is not expected until next year, as a late-stage trial is still under way in America.
Thomas Senderovitz, director of the Danish Medicines Agency (DMA) said : ‘I am a little afraid that it has gone too fast for the English. I must say’
The Oxford vaccine is a genetically engineered common cold virus that used to infect chimpanzees. It has been modified to make it weak so it does not cause illness in people and loaded up with the gene for the coronavirus spike protein, which Covid-19 uses to invade human cells
The FDA has already approved the Pfizer/BioNTech and Moderna vaccines, for which country has placed orders of 100million each.
In a coronavirus data briefing marking the vaccine’s approval in the UK, MHRA boss Dr Raine strongly insisted that ‘no corners, whatsoever’ had been cut.
She said: ‘As I have said before and will say again, the safety of the public always comes first, the MHRA’s approval has been reached following a thorough and scientifically rigorous review of all the evidence of safety, of quality and effectiveness of the vaccine.
‘As the UK regulator we take this very seriously indeed.
‘The MHRA has worked in a process known as a rolling review, which can be used to complete the review of a medicine or vaccine in the shortest time possible during a public health emergency such as this one.’
She added that the scientists had been working ‘around the clock’ and had not even stopped on Christmas Day.
A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia
Top experts, including members of SAGE, have warned ministers they need to ramp up weekly vaccination rates seven-fold to 2million by mid-January to prevent the NHS from being overwhelmed this winter. Currently about 280,000 Brits are being inoculated each week
‘Our team of scientists have very carefully, methodically and rigorously reviewed all the data on safety, quality and effectiveness as soon as they became available all around the clock.’
Officials have said the vaccine will be made available ‘from next week’, while Health Secretary Matt Hancock claimed the approval now offers ‘high confidence’ the UK could ‘get out of this by spring’.
It has been approved for over-18s, with the recommendation that two doses be administered, but said there can be an up to 12 week gap between them.
The vaccine is also easier to roll out than the Pfizer/BioNTech jab, which while 95 per cent effective requires ‘deep-freezing’, meaning the 62 per cent effective Oxford vaccine will be more popular at a local level because it only needs to be stored in a fridge.