Pfizer-BioNTech Covid Shot to Get European Review Next Week
(Bloomberg) -- European regulators will review Pfizer Inc. and BioNTech SE’s Covid-19 vaccine next week, earlier than initially planned, amid growing pressure across the continent to speed up approval of the shot.
A European Medicines Agency committee will meet Monday to consider the vaccine after receiving more data from the developers, the drugs watchdog said in a statement Tuesday. Once a recommendation is made, the European Commission is expected to decide whether to clear the shot within days.
Leaders in Germany, Italy and Poland, among other countries, have been pushing the European Union regulator to speed up its review as vaccination campaigns begin for high-risk people in the U.K. and U.S. Even an earlier approval date would mean immunizations start in the EU weeks after the U.K., which has become a source of frustration given that researchers in Germany developed the Pfizer-BioNTech shot and the country’s government provided financing.
Some vaccine doses are being manufactured in Belgium, and starting next year production will begin in Germany as well.
The announcement means the first EU residents will likely be immunized before the end of the year, European Commission President Ursula von der Leyen wrote in a tweet. In a turning point in the fight against Covid-19, Pfizer gained emergency U.S. authorization last week, following decisions in the U.K. and Canada. The moves paved the way for unprecedented campaigns to protect people from a pathogen that’s killed more than 1.6 million worldwide.
The EMA had previously said its advisory board would convene by Dec. 29 to make a recommendation on the application, with approval potentially coming within days after that. But German officials said Tuesday that they were optimistic the agency would be able to make a decision by Dec. 23. The country aims to start its rollout before the end of the year.
The committee “will conclude its assessment at the earliest possible time point and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” the statement read.
In contrast with the U.S. and U.K., which conducted emergency authorizations, the EMA is reviewing the vaccine for a conditional marketing authorization -- something European authorities argued might not be an apples-to-apples comparison. That process requires “a higher level of evidence,” the European Commission’s Directorate-General for Health and Food Safety said in a tweet.
The meeting planned for Dec. 29 will be kept if needed, according to the agency, Europe’s equivalent of the U.S. Food and Drug Administration.
“Every week counts,” Polish Prime Minister Mateusz Morawiecki told journalists in Brussels on Friday. “Every week implies huge human losses, new infections and massive losses for the economy.”
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