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Pressure is building in Europe for quick approval of Pfizer and BioNTech’s COVID-19 vaccine, with German authorities saying they’re optimistic that sign-off can be pushed forward by a week amid a rising death toll on the continent.
Germany is “optimistic” that the European Medicines Agency will be able to make a decision by December 23, Health Minister Jens Spahn said in Berlin on Tuesday. The EMA had previously said an advisory board would convene by December 29 to make a recommendation on the application; approval would come within days after that.
“We’re doing all we can to get this vaccine approved as soon as possible,” Spahn said. “The goal is to get approval before Christmas,” he said, adding that Germany hopes to start its rollout before the end of the year.
Leaders in Germany, Italy and Poland, among other countries, have been pushing Europe’s drugs regulator to speed up its review as vaccination campaigns begin for high-risk people in the UK and US Even the earlier Dec. 23 approval date would mean that immunisations start in Europe weeks after the UK, a particular source of frustration given German researchers were the ones to discover the Pfizer-BioNTech shot.
“One might ask why this vaccine has already been approved in other countries, but not in Germany,” Alexander Dobrindt, a senior official in Chancellor Angela Merkel’s parliamentary caucus, told journalists in Berlin. “Since we are one of the main producers of this vaccine, we should also be the first who use it.”
The European review would be “the first orderly approval of a vaccine in the world,” Spahn said.
In contrast with the US and UK, which conducted emergency authorisations, the EMA is reviewing the vaccine for a conditional marketing authorisation – something European authorities argued might not be an apples-to-apples comparison in terms of time for review. Those conditional decisions require “a higher level of evidence,” the European Commission’s Directorate-General for Health and Food Safety said in a tweet.