EU Regulator Clears The Way For Use Of Pfizer Vaccine

Enlarge this image

A sign is shown in the window of an office at Pfizer Manufacturing in Puurs, Belgium, on Monday, the same day the European Medicines Agency authorized the use of the company’s coronavirus vaccine.

Valentin Bianchi/AP

hide caption

toggle caption

Valentin Bianchi/AP

A sign is shown in the window of an office at Pfizer Manufacturing in Puurs, Belgium, on Monday, the same day the European Medicines Agency authorized the use of the company’s coronavirus vaccine.

Valentin Bianchi/AP

Updated at 10:40 a.m. ET

The European Union’s drug agency has recommended authorizing use of the coronavirus vaccine developed by Pfizer and BioNTech. If the EU’s executive arm, the European Commission, greenlights the drug, inoculations can start across Europe.

It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!

The @EMA_News just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine.

Now we will act fast. I expect a @EU_Commission decision by this evening.

— Ursula von der Leyen (@vonderleyen) December 21, 2020

«Now we will act fast. I expect a @EU_Commission decision by this evening,» Ursula von der Leyen, the commission’s president, said in a tweet on Monday.

«Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards,» Emer Cooke, the executive director of the European Medicines Agency, said in a statement.

The European regulator is recommending the use of the vaccine in people 16 or older, as U.S. federal officials did earlier this month. The U.K., no longer a member of the EU, is also already carrying out inoculations with the Pfizer vaccine.

The European agency has been under criticism in recent weeks for being slow to issue its recommendation. In addition to the U.K., the Pfizer-BioNTech vaccine has already been authorized for use in the U.S., Canada, and several other countries.

The EMA recommended a «conditional marketing authorization» — a regulatory mechanism that allows for early access to medicines due to an «unmet medical need,» in this case the pandemic.

The news comes as most EU countries have imposed travel restrictions including halting flights and trains from the U.K., where a strain of the vaccine appears to be especially transmissible – though there are not indications that the strain causes more severe cases of COVID-19.

The agency said its recommendation for the EU to approve the vaccine is a milestone in combating the coronavirus. «Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,» Cooke said.

German Health Minister Jens Spahn is among those who has pushed for the EU to speed its authorization. He has told outlets that the goal was to get the vaccine greenlit before Christmas, so that inoculations could begin this year.

NPR’s Rob Schmitz contributed to this report from Berlin.

• Pfizer vaccine
• European Commission