European Union officials slammed the UK on Wednesday for rushing its landmark approval of Pfizer’s coronavirus vaccine, saying health authorities shouldn’t put speed ahead of safety.
The British government cleared the COVID-19 shot early Wednesday, just 10 days after it started examining data from large-scale clinical trials run by Pfizer and its German partner, BioNTech.
But EU lawmakers and the bloc’s own drug regulator criticized the decision while defending their own emergency approval process, which could give Pfizer’s vaccine a green light by the end of the year.
The European Medicines Agency issued a statement saying its so-called conditional marketing authorization process “is the most appropriate regulatory mechanism for use in the current pandemic emergency,” given that it is based on more evidence and requires more checks than the UK’s.
The agency said Tuesday that it will meet by Dec. 29 to decide whether Pfizer and BioNTech’s vaccine should receive that conditional approval.
European Parliament member Peter Liese went further, calling Britain’s approval “problematic” and urging other EU countries not to repeat the super-fast process.
“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Liese, who belongs to German chancellor Angela Merkel’s center-right political party.
Tiemo Wolken, a member of the EU legislature’s socialist grouping, said he believes it’s “better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”
Both Pfizer and the UK government stood by the quick approval process. Ben Osborn, Pfizer’s UK country manager, said the company had provided complete sets of data for the shot to regulators in both the EU and Britain.
“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” said June Raine, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency, adding that the agency has worked in a way that’s “equivalent to all international standards.”
Britain becoming the first Western country to authorize a COVID-19 shot was seen as a political victory for prime minster Boris Johnson, who is overseeing the country’s exit from the EU. But the UK is still subject to the EU’s rules until it fully leaves the group at the end of this year.
With Post Wires
A Global Asset Management Seoul Korea Magazine