EU regulator gives conditional approval to COVID-19 vaccine

Aleksandar Furtula and Frank Jordans
Associated Press

Amsterdam – The European Medicines Agency says an expert committee has recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first granted permission under emergency provisions in Britain and the United States.

The decision Monday comes after a closed-door discussion during which EMA scientists responsible for assessing the vaccine presented their analysis to other experts and scrutinized data from companies.

The approval needs to be rubber-stamped by the European Commission and the pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

Authorities in Germany and several other European countries have said they hope to begin vaccinating people on Dec. 27.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

AMSTERDAM – The European Medicines Agency was meeting Monday to consider approving a coronavirus vaccine developed by BioNTech and Pfizer that would be the first to be authorized for use in the European Union.

The closed-doors meeting that began at 10 a.m. (0900 GMT) came weeks after the shot was granted permission under emergency provisions by regulators in Britain and the United States.

If EMA scientists conclude that the vaccine is safe, officials at the Amsterdam-based agency are expected to give conditional approval for it to be used across the 27-nation bloc. The European Commission must rubber stamp the decision before the vaccine can be rolled out, a process German officials say could begin Dec. 27.

The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. EMA originally set Dec. 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved up the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.

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 to date, according to a tally by Johns Hopkins University.

Switzerland became the first country Saturday to authorize the Pfizer/BioNTech vaccine according to the normal licensing procedure. EMA approval would also follow 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.

In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.

“A vaccine’s benefits in protecting people against COVID-19 must be far greater than any side effect or potential risks,” it said.

Scientists are still waiting for more long-term follow-up data to see how long immunity from the vaccines lasts and if there are any rare or serious side effects. Final testing of the vaccine is still ongoing; more information on whether the shot works in children is needed, in addition to its effects in pregnant women.

The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it’s unclear if the reactions were caused by the immunization.

The U.S. Centers for Disease Control and Prevention said that as of Friday they had seen six cases of severe allergic reaction out of more than a quarter-million shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.

BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive Commission chose to buy only 200 million doses, with an option for 100 million more.

The EMA plans to hold a meeting on Jan. 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.


Jordans reported from Berlin. Maria Cheng in Toronto contributed to this report.