Reuters Updated: December 03, 2020, 07:35 IST
BRUSSELS: The European Union‘s drug watchdog and lawmakers warned against hasty approvals of Covid-19 vaccines on Wednesday, after Britain granted emergency authorisation to the experimental Covid-19 shot being developed by Pfizerand BioNTech.
Britain is the first Western country to approve a Covid-19 vaccine, a move that many see as a political coup for Prime Minister Boris Johnson‘s government, which has faced criticism over its handling of the coronavirus crisis.
The decision was made under an emergency, ultra-fast approval process.
The European Medicines Agency (EMA), which is in charge of approving Covid-19 vaccines for the EU, said its longer procedure to approve vaccines was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.
Asked about the British approval of the Pfizer vaccine, the agency said: “EMA considers that the conditional marketing authorisation is the most appropriate regulatory mechanism for use in the current pandemic emergency.” EMA had said on Tuesday that, under that procedure, it would decide by Dec. 29 whether to authorise Pfizer’s vaccine.
EU lawmakers were critical of Britain’s decision.
“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 thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU assembly.
Under EU rules, the Pfizer vaccine must be authorised by EMA, but EU countries can use an emergency procedure that allows them to distribute in their domestic market a vaccine for temporary use.
Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.
“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the EU Parliament.
“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”
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