The European Medicines Agency (EMA) said on Monday it received from Pfizer-BioNTech “additional data” required by its committee charged with reviewing medicines for human use.
The European Medicines Agency (EMA) will meet on December 21 to evaluate the Pfizer-BioNTech coronavirus vaccine, as several European states, particularly Germany, are pushing for speedy authorization.
The Amsterdam-based EMA brought forward the meeting originally scheduled for December 29 by one week, in which it will announce whether or not the Pfizer-BioNTech vaccine will be licensed, the agency said Tuesday.
Europe is lagging behind as the UK became the first country in the world to grant emergency approval of the vaccine, followed by the US, Canada, Singapore and Bahrain.
The EMA said that on Monday it received from Pfizer-BioNTech “additional data” required by its committee charged with reviewing medicines for human use.
“An exceptional meeting [of the committee] was scheduled for December 21 to make a decision,” the EMA added in its statement.
The European Medicines Agency added that it will make a decision “only if data on the quality, safety and efficacy of the vaccine are sufficiently robust and complete to determine whether the benefits of the vaccine outweigh its risks.
The EMA also indicated that it maintains the date of January 12 to make a decision on the Moderna vaccine.
“I welcome the decision of the EMA to bring forward their meeting to discuss the Pfizer-BioNTech vaccine before Christmas,” reacted the president of the European Commission, Ursula Von der Leyen, in a message on Twitter.
“Every day counts, we are working at full speed to authorize safe and effective # COVID19 vaccines that are safe and effective,” he said, saying that it is “plausible that the first Europeans will be vaccinated before the end of 2020.”
The German government had asked the EMA to give its approval “before Christmas”.
“The aim is to get approval before Christmas,” German Health Minister Jens Spahn told a news conference in Berlin on Tuesday.
“We want to start vaccinating in Germany before the end of the year,” he said.
Berlin had supported earlier calls from Hungary and Poland for a faster decision from the EMA.
In an earlier statement, the EMA said the UK, US and Canada were faster because they granted authorization for short-term and emergency use without a license.