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The European Medicines Agency said the “historic” step paved the way for vaccines to finally start in a few days in the 27 EU countries where cases of the disease are increasing.
In this file photo taken on November 23, 2020, this image taken on November 23, 2020 shows a bottle that reads “Vaccine Covid-19” alongside the logos of the US pharmaceutical company Pfizer and the German biotechnology company Biontech. November 23, 2020. Image: AFP
THE HAGUE – The EU drug regulator gave the green light to Pfizer-BioNTech’s coronavirus vaccine on Monday, saying there was no evidence that it would not work against a new strain spreading in Britain.
The European Medicines Agency said the “historic” step paved the way for vaccines to finally start in a few days in the 27 EU countries where cases of the disease are increasing.
The Amsterdam-based watchdog had advanced the decision since December 29 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 Director Emer Cooke said at an online press conference announcing the decision.
“This is really a historic scientific achievement, in less than a year a vaccine against this disease will have been developed and licensed.”
Following the recommendation of the EMA, the European Commission is ready to formally approve within hours a one-year “conditional marketing authorization” for the vaccine developed by the US giant Pfizer and the German company BioNTech.
“This is a watershed moment in our efforts to provide safe and effective vaccines to Europeans!” The head of the European Commission, Ursula von der Leyen, said on Twitter.
“Now we will act fast. I await a decision from the European Commission by tonight.”
‘ROAD OUT OF THE CRISIS’
German Health Minister Jens Spahn said the decision allowed “to get out of the crisis” and that elderly patients could receive the first vaccines from December 26.
Italian Health Minister Roberto Speranza said the EMA’s decision “is the news we have been waiting for.”
BioNTech and Pfizer said Monday they were “ready” to deliver their vaccines once the European Commission gives its go-ahead.
The urgency surrounding the virus has heightened with news that a rapidly spreading variant is sweeping Britain, prompting a growing number of countries around the world to suspend flights from the UK.
But EMA officials said it was “very likely” that the Pfizer-BioNTech coup worked against the new strain.
“There is no evidence at this time to suggest that this vaccine will not work against the new variant,” Cooke said.
EMA head of vaccine strategy Marco Cavaleri added that while waiting for more data “at the moment we are not too worried.”
“It is very likely that the vaccine also maintains protection against this new variant,” he said.
“What would scare us is if we see multiple mutations,” particularly in the “spike” that the virus uses to enter human cells, but which have yet to be seen, Cavaleri added.
‘CAUSE FOR CONCERN’
The EMA has been under enormous pressure to speed up the process, and German-led governments are wondering why Britain and the United States were able to authorize the vaccine earlier.
He said the delay was because a conditional marketing authorization is more comprehensive and lasts longer than the emergency authorization used by London and Washington.
The EMA has also had to deal with a cyber attack in which data was stolen from the Pfizer-BioNTech and Moderna vaccines.
Cooke said the agency had “worked around the clock” to speed things up, but needed to make sure the Pfizer-BioNTech vaccine was safe and effective, to avoid any doubts that could affect uptake.
“We know very well that the speed at which these vaccines were developed and licensed is of concern to many Europeans,” said Harald Enzmann, chairman of the EMA committee that made the final decision.
But he said the authorization 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.”
The authorization is only for those over 16 years of age and says 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 recommended that people be kept under “close observation” for 15 minutes after vaccination.
The decision on another vaccine produced by the American firm Moderna is scheduled for January 6.
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