Europe may approve vaccine by Christmas

By Naomi Kresge and Arne Delfs
Bloomberg News/TNS

Pressure is building in Europe for quick approval of Pfizer Inc. and BioNTech SE’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 Dec. 23, Health Minister Jens Spahn said in Berlin on Tuesday. The EMA had previously said an advisory board would convene by Dec. 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 U.K. and U.S. Even the earlier Dec. 23 approval date would mean that immunizations start in Europe weeks after the U.K., 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.

The agency is working “around the clock” on the vaccine and may make a decision before Dec. 29, Executive Directer Emer Cooke told Germany’s Handelsblatt newspaper. Still, that remains the date planned for clearance, German magazine Focus cited an EMA spokeswoman as saying. The agency’s press office didn’t immediately return requests for comment on Tuesday.

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 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.

The European process also means shipping doses throughout the EU, where countries are making their own plans for distribution. In Germany, vaccination centers were told to be ready by Tuesday. In Italy, where the government is still finishing its deployment plan, Health Minister Roberto Speranza said he hoped the vaccine would get a sign-off ahead of schedule.

“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.

Vanessa Arroyo, a nurse, receives a COVID-19 vaccine from nurse Rafael Martinez on Monday, Dec. 14, 2020 at Tampa General Hospital in Tampa, Florida. Tampa General Hospital was one of the first hospitals to receive the vaccine.