The European Medicines Agency recommended conditional approval on Monday for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first approved in the UK and US.
Following a closed-door expert meeting, the European Medicines Agency said it recommended the shot be given to people over the age of 16. Pharmaceutical companies will need to provide follow-up data on their vaccine for next year.
“This is truly a historic scientific achievement,” said Emer Cooke, director of the agency. “It is an important step forward in our fight against the pandemic.”
The approval must be stamped by the EU’s executive branch, a move that the chief says will probably take place on Monday night.
European Commission President Ursula von der Leyen tweeted that the EMA’s approval was “a crucial moment in our efforts to deliver safe and effective vaccines to Europeans!”
“Now we will act quickly,” she said. The EU’s executive arm was expected to take two or three days to approve the EMA’s decision.
Authorities in Germany and several other European countries have said they hope to start giving the vaccine to humans on December 27.
“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, CEO and founder of the German-based company. “Being at the heart of the EU, we are proud to be one step closer to delivering the first vaccine in Europe to combat this devastating pandemic.”
“We are ready to start delivering initial vaccine doses across the EU as soon as we get the green light,” Sahin said.
The European regulator came under heavy pressure last week from countries that demanded that the vaccine be approved for use as soon as possible. The EMA initially set December 29 as the date for its evaluation of the vaccine, but moved up to Monday’s meeting following calls from the German government and other countries for the agency to move faster.
“Our goal is an approval before Christmas,” German Health Minister Jens Spahn told reporters in mid-December. “We still want to start vaccinating this year.”
French government spokesman Gabriel Attal told reporters after a government meeting on Monday that the logistics chain was in place to start vaccinations on Sunday.
Like Germany, France will start with the elderly in nursing homes.
The Amsterdam-based EMA is responsible for approving all new drugs and vaccines in the 27 EU countries and roughly corresponds to the US Food and Drug Administration.
The vaccine has already received some form of authorization in at least 15 countries.
The UK, Canada and the US approved the use of the vaccine under emergency regulations, meaning the shot is a licensed product whose temporary use is justified by the pandemic that has so far killed nearly 1.7 million people worldwide, according to a report by Johns Hopkins University.
Switzerland became the first country on Saturday to approve the Pfizer / BioNTech vaccine under the normal licensing procedure. EMA approval also follows the usual process, only according to an accelerated schedule and provided that the pharmaceutical companies provide follow-up data on their vaccine for next year.
In a statement last week that seemed to address concerns about some in Europe about the speed of the process, the authority stressed that the vaccine would only be approved after a scientific assessment showed that its overall benefits outweigh the risks.
“The benefits of a vaccine to protect humans against COVID-19 must outweigh any side effects or potential risks,” it said.
Researchers are still waiting for more long-term follow-up data to see how long the immunity to 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 on pregnant women.
The vaccine is not made with the coronavirus itself, which means that there is no chance that anyone can catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the pointed protein on the surface of the virus.
On the day Britain launched its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people had severe allergic reactions; it is unclear if the reactions were caused by the vaccine.
The U.S. Centers for Disease Control and Prevention said that as of Friday, it had seen six cases of severe allergic reaction to more than a quarter of a million shots of the BioNTech-Pfizer vaccine, including one with a history of vaccination reactions.
BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the group’s executive commission chose to buy only 200 million doses, with an option of 100 million more.
EMA plans to hold a meeting on January 12 to decide whether the modern coronavirus vaccine should be licensed. There are ongoing reviews for a shot developed by Oxford University and AstraZeneca and another from Janssen, but none of them have made a formal request for the EMA to approve their vaccine.