EU regulator gives conditional approval for Pfizer-BioNTech coronavirus vaccine

The European Medicines Agency (EMA) said Monday that it had approved the coronavirus vaccine made by German pharmaceutical company BioNTech and American drugmaker Pfizer, paving the way for inoculations to start across the European Union within days.

"I am delighted to announce that the EMA scientific committee met today and recommended a conditional marketing authorization in the EU for the vaccine developed by Pfizer and BioNTech," EMA chief Emer Cooke told an online news conference, according to remarks carried by Agence France-Presse (AFP).

EU countries including Germany, Austria and Italy have said they plan to start vaccinations from Dec. 27 as Europe tries to catch up with the U.S. and Britain where the rollout began earlier this month.

Following a closed-door expert meeting Monday, the EU drug regulator said it was recommending the shot be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

The approval needs to be rubber-stamped by the EU's executive branch on Monday evening, a move its chief said is likely to happen.

European Commission President Ursula von der Leyen tweeted that the EMA's approval was "a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!"

"Now we will act fast. I expect a @EU_Commission decision by this evening,” she said. The EU’s executive arm had been expected to require two or three days to approve the EMA’s decision.

"Today is a particularly personal and emotional day for us at BioNTech,” said Uğur Şahin, the 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,” Şahin 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 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 using emergency powers despite it being unlicensed as the pandemic 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 and BioNTech vaccine according to the normal licensing procedure. 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, as reported by The Associated Press (AP).

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 on pregnant women.

The vaccine is not made with the coronavirus itself, meaning there’s no chance of catching it through the shot. 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 (CDC) 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 and Pfizer vaccine given, including 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 has made a formal request for the EMA to approve their vaccine.