Mon, 18 Jan 2021

The European Union on Monday approved the coronavirus vaccine developed by BioNTech and Pfizer to be approved for use across the 27-nation bloc.

European Commission President Ursula von der Leyen said the commission "took the decision to make available for European citizens the first Covid-19 vaccine. We granted conditional market authorisation."

The commission, the EU's executive arm, gave the green light just hours after the European Medicines Agency (EMA), the EU drug regulator, said the vaccine meets the bloc's safety and quality standards. The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states and is roughly equivalent to the US Food and Drug Administration.

The vaccine has already been given some form of regulatory authorisation in at least 15 countries, including in Britain and the United States.

Deliveries of the vaccine are expected to start on Saturday, with EU countries including Germany, Austria and Italy having said they plan to start vaccinations from Sunday.

"Today we add an important chapter to a European success story, by making available the first #COVID19 vaccine for Europeans. More will come. It will be available to all EU countries at the same time, on the same conditions," von der Leyen tweeted.

Following a closed-doors meeting earlier in the day, the EMA said it was recommending the shot be given to people over 16 years of age. The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

"This is really a historic scientific achievement," said Emer Cooke, the head of the agency. "It is a significant step forward in our fight against the pandemic."

"Today is a particularly personal and emotional day for us at BioNTech," said Ugur Sahin, the Germany-based company's chief executive and co-founder. "Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic."

"We are standing by ready to start the delivery of 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 calling for the vaccine to be granted approval for use as quickly as possible. EMA originally set December 29 as the date for its evaluation of the vaccine, but moved up the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.

French government spokesman Gabriel Attal told reporters after a Cabinet meeting Monday that the logistical chain was in place to start vaccinations by Sunday. Like Germany, France will start with elderly people in nursing homes.

Britain, Canada and the US authorised 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 authorise the Pfizer/BioNTech vaccine according to the normal licensing procedure. EMA approval also follows 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 recognise the spiked protein on the surface of the virus.

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

The EMA plans to hold a meeting on January 12 to decide if the coronavirus vaccine made by Moderna should also 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.

(FRANCE 24 with AP)

Originally published on France24

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