Coronavirus vaccine approved for France as EU regulator gives green light
A vaccine against the coronavirus causing Covid-19 was cleared for use in France and other European Union member states for the first time on Monday as regulators granted conditional approval to a vaccine developed by US firm Pfizer and its German partner BioNTech.
The Amsterdam-based European Medicines Agency (EMA) said experts had recommended conditional authorisation of the Pfizer-BioNTech vaccine in an emergency meeting on Monday.
📢 EMA has just recommended granting a conditional marketing authorisation for the #COVID19vaccine developed by BioNTech/ Pfizer, to prevent #COVID19 in people from 16 years of age.— EU Medicines Agency (@EMA_News) December 21, 2020
👉Read our press release: https://t.co/qOyMcYLI4y pic.twitter.com/4c5ujZKQ6b
“I am delighted to announce that the EMA scientific committee met today and recommended a conditional marketing authorisation in the EU for the vaccine developed by Pfizer and BioNTech,” the agency’s chief Emer Cooke told an online press conference.
The agency said in a statement that conditional marketing authorisation meant formal authorisation of use that obliged the companies to continue providing follow-up data on the vaccine for two years.
“This is really a historic scientific achievement,” Cooke said. “It is a significant step forward in our fight against the pandemic.”
The European Union (EU) executive body, the European Commission, was expected to rubber stamp the decision later on Monday.
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!— Ursula von der Leyen (@vonderleyen) December 21, 2020
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.
“It’s a decisive moment in our efforts to deliver save and effective vaccines to Europeans,” Commission President Ursula von der Leyen wrote on social media. “I expect an EU Commission decision by this evening.”
Inoculations to begin Sunday
France along with Germany and several other countries said it hoped to begin vaccinating people on Sunday, 27 December.
The EMA came under pressure to grant emergency approval as quickly as possible after similar provisions were made in Britain and the United States in recent weeks.
Conditions for emergency approval oblige the companies to submit follow-up data on their vaccine for the next year.
The regulator said the vaccine would be licenced for use in people over 16 years of age, with some exceptions.
“Although large numbers of people have received Covid-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated,” the EMA statement said.
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