EU lights up COVID-19 vaccine after agency gives OK safety

AMSTERDAM (AP) – The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer for use across the 27-nation bloc, raising hopes that countries can start taking the first photos of their citizens shortly after Christmas.

The EU executive commission gave the green light a few hours after the European Medicines Agency said the vaccine met safety and quality standards. It was expected that Brussels would take two or three days to approve the market authorization process.

“As promised, this vaccine will be available to all EU countries at the same time, under the same conditions,” said European Commission President Ursula von der Leyen. “This is a great way to end this difficult year and finally start turning the page on COVID-19.”

Vaccine deliveries were scheduled to begin next Saturday, with inoculations starting in the EU on Dec. 27-29, she said.

The same vaccine was approved in the United Kingdom and the United States a few weeks ago, prompting pressure from EU governments to speed up the EMA’s approval process, as virus cases have risen again across the continent.

The 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 for the agency to move faster.

Harald Enzmann, head of the EMA’s committee of experts, rejected any suggestion that political influence would have affected the decision.

“The focus was exclusively on science,” he told reporters. “It was a scientific assessment, a final point.”

The Amsterdam EMA is responsible for approving all new medicines and vaccines in the 27 EU Member States, Iceland, Liechtenstein and Norway. It is roughly equivalent to the US Food and Drug Administration.

The vaccine has already received a form of regulatory authorization in at least 15 countries.

The UK, Canada and the US have authorized the use of the vaccine in accordance with the emergency provisions, which means that the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed nearly 1.7 million people worldwide, according to a review of Johns Hopkins University.

On Saturday, Switzerland became the first country to authorize the vaccine under the normal licensing procedure. EMA’s conditional market authorization also followed the regular process, only in an accelerated program and provided that pharmaceutical companies submit follow-up data on their vaccine for the following year.

While many have applied for vaccine authorization, there have also been concerns in Europe and elsewhere about the speed with which the vaccine has developed. Vaccines normally take years to develop and approve, not months.

In a statement last week that seemed to address those concerns, the agency stressed that the vaccine will only be approved after a scientific assessment shows that its overall benefits outweigh the risks.

Scientists are still waiting for more long-term follow-up data to see how long the immunity to the vaccine lasts and whether there are rare or serious side effects. The final testing of the vaccine is still ongoing and more information is needed on the effectiveness of the vaccine in children. EMA experts also said that data on pregnant women are limited and doctors should decide on a case-by-case basis.

The vaccine is not made with the coronavirus itself, which means there is no chance that someone will catch it from the photos. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the peak protein on the surface of the virus.

On the day the UK began its vaccination campaign, authorities warned people with severe allergies not to be shot after two people suffered 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 have been six cases of severe allergic reactions in the United States since Friday out of more than a quarter of a million vaccines given by BioNTech-Pfizer, including one with a history of vaccination reactions.

Adding to an already appalling tax have been concerns about a newly identified strain that seems to be spreading more easily.. But experts have expressed confidence that the new vaccine will continue to be effective against it.

“At this time, we can say that there is no evidence to suggest that the vaccine will not work against the new variant of coronavirus,” said Emer Cooke, head of the drug regulatory authority, after a closed-door meeting in which experts recommended unanimously shooting people over 16 years.

But she added that protection measures such as wearing masks, washing hands and social distancing would probably be necessary for a period of time.

“Vaccines alone will not be the silver bullet that will allow us to return to normal life,” Cooke said. “But the authorization of this first vaccine is certainly a major step in the right direction and an indication that 2021 may be brighter than 2020.”

The EU has ordered 300 million doses of BioNTech-Pfizer vaccine; two are needed for each person, which means that more shots will be needed to immunize all the nearly 450 million people in the block.

The EMA intends to hold a meeting on 6 January to decide whether another vaccine produced by Moderna should be authorized. He has ongoing reviews for a photo developed by Oxford University and AstraZeneca and another from Janssen, but none of them have made a formal request for the EMA to approve its vaccine.

“Today is a very personal and emotional day for us at BioNTech,” said Ugur Sahin, executive director and co-founder of the German company. “Being in the heart of the EU, we are delighted to be one step closer to delivering the potential delivery of Europe’s first vaccine to help fight this devastating pandemic.”


Jordanians reported from Berlin. Associated Press writers Maria Cheng of Toronto and Lorne Cook of Brussels contributed to this report.


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