EU watchdog approves Pfizer-BioNTech vaccine

The European Medicines Agency said the 'historic' step paved the way for vaccinations to finally start within days across the 27-nation EU where cases of the disease are surging.

FILE: This file picture taken on November 23, 2020 shows a bottle reading "Vaccine COVID-19" next to US pharmaceutical company Pfizer and German biotechnology company BioNTech logos. Picture: AFP

THE HAGUE - The EU's drug regulator gave the green light for the Pfizer-BioNTech coronavirus vaccine on Monday, and said there was no evidence it would not work against a new strain spreading in Britain.

The European Medicines Agency said the "historic" step paved the way for vaccinations to finally start within days across the 27-nation EU where cases of the disease are surging.

The Amsterdam-based watchdog had moved the decision forward from 29 December under pressure from EU governments, after Britain and the United States gave the green light weeks earlier.

"It is a significant step forward in the fight against this pandemic that is causing suffering and hardship," EMA chief Emer Cooke told an online press conference as she announced the decision.

"This is really a historic scientific achievement, within less than a year a vaccine will have been developed and authorised against this disease."

Following the EMA's recommendation, the European Commission is set to formally sign off within hours on a one-year "conditional marketing authorisation" for the vaccine developed by US giant Pfizer and German firm BioNTech.

"It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!" European Commission chief Ursula von der Leyen said on Twitter.

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


German Health Minister Jens Spahn said the decision allowed a "road out of the crisis" and that elderly patients could receive the first vaccinations as early as 26 December.

Italian Health Minister Roberto Speranza said the EMA decision "is the news we have been waiting for".

BioNTech and Pfizer said Monday they were "standing by ready" to deliver their vaccines once the European Commission gives its nod.

The urgency surrounding the virus has increased with the news that a fast-spreading variant is sweeping Britain, prompting a growing number of countries worldwide to suspend flights from the UK.

But EMA officials said it was "very likely" the Pfizer-BioNTech jab would work against the new strain.

"At this moment there is no evidence to suggest this vaccine will not work against the new variant," Cooke said.

The EMA's head of vaccine strategy, Marco Cavaleri, added that while they were waiting for more data "for the time being we are not too worried".

"It is very likely that the vaccine will retain protection also against this new variant," he said.

"What would scare us is if we see multiple mutations", particularly on the "spike" that the virus uses to enter human cells, but those had not been seen yet, Cavaleri added.


The EMA has been under huge pressure to speed up the process with governments led by Germany asking why Britain and the United States were able to authorise the vaccine sooner.

It said the delay was because a conditional marketing authorisation is more thorough and lasts longer than the emergency authorisation used by London and Washington.

The EMA has also had to contend with a cyberattack in which data from the Pfizer-BioNTech and Moderna vaccines was stolen.

Cooke said the agency had "worked night and day" to speed things up, but needed to make sure the Pfizer-BioNTech vaccine was safe and effective, in order to avoid any doubts that could affect uptake.

"We know very well that the speed at which these vaccines were developed and authorised is a cause of concern for many Europeans," said Harald Enzmann, chairman of the EMA committee that took the final decision.

But he said the authorisation followed "one of the largest trials we have ever evaluated for a vaccine" and that it "met the standards for robustness and quality that we have set out".

The authorisation is for over-16s only and says that the vaccine should be given to pregnant women on a case by case basis, the EMA said.

Following a "small number" of reports of allergic reactions in Britain and the United States, the EMA had recommended that people should be kept under "close observation" for 15 minutes after vaccination.

A decision on another vaccine produced by US firm Moderna is due by 6 January.

Download the EWN app to your iOS or Android device.