EU greenlights vaccine after agency approval
AMSTERDAM — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas.
The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move.
“As we have promised, this vaccine will be available for all EU countries at the same time, on the same conditions,” said European Commission President Ursula von der Leyen.
Deliveries of the vaccine had been penciled in to start this coming Saturday, with inoculations beginning across the EU between Dec. 27-29, she said.
The same vaccine was authorized in Britain and the United States weeks ago, prompting pressure from EU governments for EMA to speed up its approval process as virus cases surged again across the continent.
EMA originally set Dec. 29 as the date for evaluating the vaccine, but moved up the meeting to Monday after calls from the German government and others for the agency to move more quickly.
Harald Enzmann, the head of EMA’s expert committee, dismissed any suggestion that political influence had affected the decision.
“The focus was exclusively on the science,” he told reporters. “That was a scientific assessment, full stop.”
The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein and Norway. It is roughly equivalent to the U. S. Food and Drug Administration.
The vaccine has already been given some form of regulatory authorization in at least 15 countries.
Britain, Canada and the U. S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to a tally by Johns Hopkins University.
Switzerland became the first country Saturday to authorize the vaccine according to the normal licensing procedure. EMA’s conditional market authorization also followed the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.