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The European Union has criticized the UK’s swift approval of the Covid-19 vaccine from Pfizer and BioNTech, saying its own procedure was more comprehensive.
The move to grant emergency clearance to Pfizer / BioNTech was made through an ultra-fast emergency approval process.
It allowed the British drug regulator to temporarily license the vaccine just ten days after it began examining data from large-scale trials.
In an unusually strong statement, the European Medicines Agency (EMA), which is in charge of approving Covid-19 vaccines for the EU, said its longer approval procedure was more appropriate.
He said it was based on more evidence and required more checks than Britain’s chosen emergency procedure.
The agency said yesterday that it would decide before December 29 whether to provisionally authorize the vaccine from US pharmaceutical company Pfizer and its German partner BioNTech.
A spokesman for the European Commission said that the EMA procedure was “the most effective regulatory mechanism to grant access to all EU citizens to a safe and effective vaccine”, as it was based on more evidence.
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June Raine, head of Britain’s Medicines and Health Regulatory Agency (MHRA), defended her decision.
“The way the MHRA has worked is equivalent to all international standards,” he said.
The EMA began an ongoing review of preliminary Pfizer trial data on October 6, an emergency procedure aimed at speeding up possible approval, which typically takes at least seven months from receipt of complete data.
The UK regulator launched its own rolling review on October 30 and analyzed less data than it made available to the EMA.
“If you evaluate only partial data as they are doing, they also take minimal risk,” said former EMA director Guido Rasi.
“I personally would have expected a robust review of all the available data, which the British government has not done to be able to say that without Europe you are first,” he added.
MEPs were even more explicit in their criticism of Britain’s measure.
“I consider this decision to be problematic and I recommend that EU member states do not repeat the process in the same way,” said Peter Liese MEP, who is a member of German Chancellor Angela Merkel’s party.
“A few weeks of careful scrutiny by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Liese, who represents the center-right group, the largest in the EU Parliament. .
Under EU regulations, the Pfizer vaccine must be licensed by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.
Britain remains subject to EU rules until it leaves the bloc entirely at the end of the year.
“There is an obvious global race to get the vaccine on the market as quickly as possible,” said Tiemo Wolken MEP, from the socialist group, the second largest in Parliament.
“However, I think it is better to take the time and make sure that the quality, efficacy and safety are guaranteed and are in line with our EU standards.”
British Health Minister Matt Hancock said that Brexit has helped the UK become the first country in the world to have a clinically licensed vaccine.
He told Times Radio: “And the reason we have been able to move so fast, and the UK is the first country in the world to have a clinically licensed vaccine, the reason is twofold.
“First of all, because MRHA has done a great job of working with the company to see that data as it comes in 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, while until the beginning of this year we were at the European Medicines Agency (EMA), due to Brexit, we were able to make a decision to do so based on the UK regulator, a world class regulator, and not keep up with the Europeans, who go a little slower.
“We do the same security checks and the same processes, but we have been able to accelerate the way they are done thanks to Brexit.”
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