The European Medicines Agency (EMA) recommended conditional approval for coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first granted permission under emergency provisions in Britain and the United States.
Following a closed-doors 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.
“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.”
The approval needs to be rubber-stamped by the EU’s executive branch–a move its chief said is likely to happen on Monday evening.
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!”
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,” she said. The EU’s executive arm had been expected to require two or three days to approve the EMA’s decision.
Authorities in Germany and several other European countries have said they hope to begin vaccinating people on December 27.
“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, 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,” Sahin said.
The European regulator came under heavy pressure last week from different 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 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 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 on 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.
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