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The European Union on Wednesday criticized the UK’s swift approval of the COVID-19 vaccine developed by Pfizer and BioNTech, arguing that its own procedure is more in-depth, Reuters reports. The backlash comes after Britain became the first Western country to approve a coronavirus vaccine.
The vaccine was urgently approved using a fast-track procedure that allowed the UK drug regulator to temporarily authorize the vaccine, just ten days after it began examining data from clinical trials.
But the European Medicines Agency (EMA), which is responsible for approving COVID-19 vaccines for the EU, said its longer approval process is more in-depth because it is based on more evidence and requires more controls. than the emergency procedure chosen by the UK.
The agency announced Tuesday that it would decide by December 29 whether to provisionally license the Pfizer-BioNTech vaccine.
A spokesperson for the European Commission said that the EMA procedure is “the most effective regulatory mechanism to give all EU citizens access to a safe and effective vaccine” because it is based on more evidence.
June Raine, director of the UK Medicines and Medicines Agency (MHRA), defended her decision.
“The way the MHRA has operated is equivalent to all international standards,” he said.
The EMA began a review of preliminary data from the Pfizer studies on October 6, an urgent procedure to expedite possible approval, which typically takes at least seven months from receipt of complete data.
The UK regulator released its own review on October 30 and analyzed less data than is available to the EMA.
“If you evaluate only partial data, you run a minimal risk,” Guido Rasi, the former head of EMA, told an Italian radio station.
“Personally, I would have expected a robust review of all available data, which the British government did not do,” he added.
The move was seen by many as a political coup by British Prime Minister Boris Johnson, who completed Brexit, the process by which the country left the EU, and faced criticism for the way he handled the pandemic.
Editing: Monica Bonea
