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The European Union has criticized the UK for the swift approval of the Pfizer / BioNTech vaccine against Covid-19, the EU blockade said its procedure is more detailed, Reuters reports.
The decision to grant emergency clearance for this vaccine is seen by many as a political blow given by British Prime Minister Boris Johnson, who led his country on the road outside the EU, but also during the pandemic, being criticized for management of the situation.
The UK decision was made through an ultra-fast and urgent approval procedure, which allowed the UK authorities to issue a temporary vaccine approval just 10 days after the start of the clinical trial data study. widely.
In an unusually critical statement, the European Medicines Agency (EMA), which manages the approval of coronavirus vaccines in the EU, said a longer procedure is needed because it relies on more data and involves more checks. . compared to the emergency procedure chosen by the United Kingdom.
EMA said on Tuesday that it will decide by December 29 whether to grant provisional authorization for the vaccine developed by the partnership between American firm Pfizer and German firm BioNTech.
June Raine, head of the British Regulatory Agency (MHRA), defended her decision: “The way the MHRA has acted complies with all international standards.”
Also, when asked whether leaving the EU earlier this year had any influence on the speed of approval, Raine said her agency used European legislation, which applies until the end of the year, when it ends. the transition period. in Brexit.
“We were able to authorize the supply of this vaccine using the provisions of the European law, which is valid until January 1. Our progress has only depended on the data available for analysis and the rigorous and independent evaluations we have received.” , he has declared.
EMA began analyzing preliminary Pfizer test data on 6 October, through an emergency procedure designed to speed eventual approval as much as possible. The procedure usually takes at least 7 months from receipt of complete data.
The UK regulator launched its analysis on October 30 and analyzed less data than what the EMA had available, notes Reuters.
Under EU legislation, the Pfizer vaccine must be authorized by EMA, but EU countries can use an emergency procedure to distribute it internally for temporary use.
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