Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by U.S. giant Pfizer and Germany’s BioNTech, officials said, as inoculations get started in Britain and the United States.
The push underscores the frictions between regulators and governments wishing to curb the pandemic that has killed more than 1.6 million people worldwide.
Four EU sources told Reuters that the European Medicines Agency (EMA) has been under pressure from the European Commission and EU governments to approve vaccines more quickly.
One EMA official said on Monday pressure had increased on the agency from EU governments “through usual channels of communications” after Dec. 2, when the British regulator granted an emergency authorisation to the Pfizer/BioNTech vaccine.
A second source familiar with EMA’s work confirmed pressure has increased after approvals elsewhere.
Britain’s regulator used a procedure allowed under EU rules in exceptional cases, but EU authorities declined to follow the same route because they said it was not appropriate for vaccines that need thorough assessment.
“All the necessary data on BioNTech are available,” German Health Minister Jens Spahn wrote on Twitter on Sunday. “UK + US have already granted approval. An assessment of the data and an approval by EMA should happen as fast as possible.”
EMA said in emailed statements to Reuters in recent days that it was not under political pressure to be faster. It declined to comment on Monday about Spahn’s remarks.
The European Commission denied exerting pressure on EMA for a faster approval.
Source : Reuters
