European regulators will review Pfizer Covid vaccine next week

European regulators will review Pfizer Inc. and BioNTech SE’s Covid-19 vaccine next week, sooner than initially expected, amid growing pressure across the continent to accelerate approval of the shot.

A committee from the European Medicines Agency will meet Monday to consider the vaccine after receiving more data from the developers, the drug watchdog said in a statement Tuesday. Once a recommendation has been made, the European Commission should decide whether to cancel the shot within a few days.

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Leaders in Germany, Italy and Poland, among other countries, have pushed the EU regulator to speed up its review when vaccination campaigns for high-risk people begin in the UK and the US. Early approval would mean the start of vaccinations in the EU weeks after the UK, which became a source of frustration as researchers in Germany developed the Pfizer-BioNTech coup and the country’s government provided funding.

Some doses of the vaccine are being produced in Belgium and, starting next year, production will also begin in Germany.

The announcement means that early EU residents will likely be immunized before the end of the year, European Commission President Ursula von der Leyen tweeted. At a turning point in the fight against Covid-19, Pfizer obtained US emergency clearance last week, following decisions in the UK and Canada. The moves paved the way for unprecedented campaigns to protect people from a pathogen that has killed more than 1.6 million people worldwide.

Previous meeting

EMA previously said its advisory board would meet by December 29 to make a recommendation on the application, with approval that could come within days. But German officials said on Tuesday they were optimistic that the agency would be able to make a decision by 23 December. The country aims to start its launch before the end of the year.

The committee “will conclude its evaluation as soon as possible and only once the data on the quality, safety and efficacy of the vaccine are robust and complete enough to determine whether the benefits of the vaccine outweigh its risks,” the statement read.

In contrast to the US and UK, which have conducted emergency clearances, EMA is reviewing the vaccine for conditional marketing authorization – something European authorities have argued may not be an apple comparison. and apples. This process requires “a higher level of evidence,” the European Commission’s Directorate-General for Health and Food Safety said in a tweet.

The meeting scheduled for December 29 will be held, if necessary, according to the agency, the European equivalent of the US Food and Drug Administration.

“Every week counts,” Polish Prime Minister Mateusz Morawiecki told reporters in Brussels on Friday. “Every week means huge human losses, new infections and huge losses to the economy.”

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