Questions are being asked about how quickly the UK has managed to endorse the University of Oxford / AstraZeneca ‘groundbreaking’ jab.
Britain yesterday became the first and only country to give the green light for the use of the vaccine, following rigorous testing which found that no one who had been given the vaccine has had serious injuries. sick.
Dr June Raine, chief executive of the Medicines and Health Products Regulatory Agency (MHRA), said the shot had been the subject of “ ongoing review ”, which expedited its delivery by compared to a process that is generally several years long.
But European scientists are skeptical of how quickly the regulator was able to approve it for emergency use.
Thomas Senderovitz, Director of the Danish Medicines Agency (DMA), said: “I’m a little worried this has gone too fast for the British. I must say.
Questions are being asked about how quickly the UK has managed to endorse the University of Oxford / AstraZeneca ‘groundbreaking’ jab. Pictured: A volunteer receives the coronavirus vaccine, which received approval yesterday
“We actually know what data they looked at, and here our perception of what is reasonable to approve is quite different right now.
He told the new Danish site DR: ‘However, that doesn’t necessarily mean that it can’t be approved by the European Medicines Agency, EMA, if there are better answers on the table.
“But at the moment, there is a long way to go.
Meanwhile, the European Medicines Agency (EMA) said it had not received enough data to give the Oxford / AstraZeneca vaccine conditional authorization, adding that even an approval date in January was unlikely. .
The Food and Drug Administration (FDA) in the United States said approval was not expected until next year because an advanced stage trial is still ongoing in America.
Thomas Senderovitz, Director of the Danish Medicines Agency (DMA), said: “I’m a little worried this has gone too fast for the British. I must say’
The Oxford vaccine is a genetically modified cold virus that infected chimpanzees. It has been modified to make it weak so as not to cause disease in humans and loaded with the coronavirus spike protein gene, which Covid-19 uses to invade human cells
The FDA has already approved the Pfizer / BioNTech and Moderna vaccines, for which the country has placed orders of $ 100 million each.
In a coronavirus data briefing marking the approval of the vaccine in the UK, MHRA boss Dr Raine strongly insisted that ‘no corner whatsoever’ is had been cut.
She said: ‘As I have said before and I will say it again, public safety always comes first, MHRA approval was obtained after a thorough and scientifically rigorous review of all evidence of safety. , the quality and efficacy of the vaccine. .
“As a UK regulator, we take this very seriously.
“The MHRA has worked through a process known as continuous review, which can be used to complete the review of a drug or vaccine as quickly as possible during a health emergency. public like this.
She added that the scientists worked “around the clock” and did not even stop 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 increase weekly vaccination rates seven-fold to 2 million by mid-January to prevent the NHS from being overwhelmed this winter. Currently, around 280,000 Britons are vaccinated every week
“Our team of scientists very carefully, methodically and rigorously reviewed all data on safety, quality and efficacy as soon as it became available around the clock.
Officials said the vaccine would be available ‘from next week’, while Health Secretary Matt Hancock said the approval now offered ‘great confidence’ in the UK to “ get out of it by spring ”.
It was approved for those over 18, with the recommendation to give two doses, but said there may be a gap of up to 12 weeks between them.
The vaccine is also easier to deploy than the Pfizer / BioNTech vaccine, which, while being 95% effective, requires “ freezing, ” meaning the Oxford vaccine 62% effective will be more popular in the world. local level because it is sufficient that it be kept in the refrigerator.