AMSTERDAM (AP) – The European Union gave official approval on Monday for the coronavirus vaccine developed by BioNTech and Pfizer for use in the 27-country bloc, raising hopes that countries can start administering the first shots to their citizens shortly after Christmas.
The EU executive committee gave the green light a few hours after the European Medicines Agency said the vaccine meets safety and quality standards. It was expected that Brussels took two or three days to approve the move of the market permit.
“As we have promised, this vaccine will be available to all EU countries at the same time and under the same conditions,” said Ursula von der Leyen, President of the European Commission. “This is a very good way to end this difficult year and finally turn the page on COVID-19.”
Deliveries of the vaccine were scheduled to begin next Saturday, with vaccinations starting across the EU between December 27 and 29, she said.
The same vaccine was approved in Britain and the United States weeks ago, putting pressure on EU governments to speed up EMA’s approval process as virus cases rose across the continent again.
EMA originally set December 29 as the date for the vaccine evaluation, but moved the meeting to Monday after calls from the German government and others to the agency to move faster.
Harald Enzmann, the head of the EMA’s expert committee, rejected any suggestion that political influence had influenced the decision.
“The focus was solely on science,” he told reporters. “That was a scientific assessment, period.”
The Amsterdam-based EMA is responsible for approving all new medicines and vaccines in the 27 EU member states, Iceland, Liechtenstein and Norway. It’s roughly equivalent to the US Food and Drug Administration.
The vaccine has already received some form of regulatory approval in at least 15 countries.
Britain, Canada and the US have approved emergency use of the vaccine, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that killed nearly 1.7 million people worldwide , according to a census from Johns Hopkins University.
Switzerland became the first country to allow the vaccine according to the normal licensing procedure on Saturday. The EMA’s conditional marketing authorization also followed the regular process, only on an accelerated schedule and on the condition that the pharmaceutical companies submit follow-up data on their vaccine for the coming year.
While many have argued for the vaccine to be approved, there are also concerns, in Europe and elsewhere, about the speed at which the shot was developed. Normally vaccines take years to develop and approve, not months.
In a statement last week that appeared to address these concerns, the agency stressed that the vaccine would only be approved after a scientific review showed that the overall benefits outweigh the risks.
Scientists are still waiting for more long-term follow-up data to see how long immunity to the vaccine lasts and whether there are rare or serious side effects. Final testing of the vaccine is still underway and more information is needed as to whether the injection works in children. EMA experts also said data on pregnant women is limited, and doctors need to make a case-by-case decision.
The vaccine is not made with the coronavirus itself, which means no one can catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the enriched protein on the surface of the virus.
On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to prick after two people had severe allergic reactions; it is unclear whether the reactions were caused by the vaccine.
The U.S. Centers for Disease Control and Prevention said there were six cases of severe allergic reaction in the U.S. as of Friday out of a total of more than a quarter of a million injections of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.
In addition to the already dire toll, there were concerns about a newly identified species that appears to be spreading more easily. But experts expressed confidence that the new vaccine would still be effective against it.
“At the moment we can say that there is no evidence that the vaccine will not work against the new variant of the coronavirus,” said Emer Cooke, the drug regulator’s chief, after a behind-closed meeting in which experts unanimously recommended the inclusion for people over the age of 16.
But she added that protective measures such as wearing masks, washing hands, and social distancing will likely be needed for some time.
“Vaccines alone will not be the silver bullet that will allow us to return to normal life,” Cooke said. “But the approval of this first vaccine is certainly an important step in the right direction and an indication that 2021 may be brighter than 2020.”
The EU has ordered 300 million doses of the BioNTech-Pfizer vaccine; it takes two for each person, which means it takes other shots to immunize all of the nearly 450 million residents of the block.
The EMA plans to hold a meeting on January 6 to decide whether another Moderna vaccine should be licensed. It has ongoing reviews for an injection developed by Oxford University and AstraZeneca and another from Janssen, but neither has made a formal request to the EMA to approve their vaccine.
“Today is a very personal and emotional day for us at BioNTech,” said Ugur Sahin, the chief executive and co-founder of the Germany-based company. “Being at the heart of the EU, we are delighted to be one step closer to the possible delivery of the first vaccine in Europe to help combat this devastating pandemic.”
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Jordans reported from Berlin. The Associated Press authors Maria Cheng in Toronto and Lorne Cook in Brussels contributed to this report.
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