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BRUSSELS: The European Union criticized Britain’s swift approval of the COVID-19 vaccine from Pfizer and BioNTech on Wednesday (December 2), saying its own procedure was more comprehensive, after Britain became the first country in backing a COVID-19 injection.
The decision to grant emergency authorization to the Pfizer / BioNTech vaccine has been seen by many as a political blow to UK Prime Minister Boris Johnson, who pulled his country out of the EU and faced criticism for his handling of the pandemic.
The decision was made through a lightning-fast emergency approval process, which allowed the British drug regulator to temporarily authorize the vaccine just 10 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 because it was based on more evidence and required more. controls that emergency procedure chosen by Great Britain.
READ: UK’s Johnson praises ‘fantastic’ news from vaccine authorization
The agency said on Tuesday that it would decide before December 29 whether to provisionally license the vaccine from US drugmaker Pfizer Inc and its German partner BioNTech SE.
A spokesperson for the European Commission, the EU executive, said that the EMA procedure was “the most effective regulatory mechanism to give all EU citizens access to a safe and effective vaccine” as it was based on more tests.
Ben Osborn, UK Country Manager for Pfizer, said: “We have provided full data packages, the data unblinded, to both regulators. I think what you are seeing is the difference in the underlying process and timelines, as opposed to to any difference in the sending of data.. “
June Raine, Director of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), said: “The way the MHRA has worked is equivalent to all international standards.
“Our progress has been totally dependent on the availability of data in our ongoing review and our rigorous evaluation and independent advice that we have received,” he added.
The EMA began an ongoing review of preliminary data from Pfizer’s trials on October 6, an emergency procedure intended to expedite possible approval, which generally 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.
“The idea is not to be the first, but to have a safe and effective vaccine,” German Health Minister Jens Spahn told a news conference.
READ: US scientists are developing a nasal spray to prevent COVID-19
When asked about the emergency procedure used by Britain, he said that EU countries had opted for a more comprehensive procedure to increase confidence in vaccines.
“If you evaluate only partial data as they are doing, they also run minimal risk,” former EMA director Guido Rasi told Italian radio.
“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.
‘PROBLEMATIC’
EU lawmakers were even more explicit in their criticism of Britain’s move.
“I consider this decision to be problematic and recommend that EU member states do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.
“A few weeks of comprehensive review 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, an EU lawmaker 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.”
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