Europe Accelerates Review of Pfizer-BioNTech Vaccine
Europeans were set to receive the coronavirus vaccine by year-end after the European Medicines Agency (EMA) sped up the approval process following the launch of immunization campaigns in the United Kingdom and the United States.
A report by BBC Europe said on Tuesday that members of the EMA will convene on Monday, December 21 to review the vaccine manufactured by pharmaceutical giant Pfizer and its German partner BioNTech.
Previously, EMA said that the meeting would push through on December 29.
While the regional regulator’s mandate was to issue recommendations on new medical drugs, the European Commission said that any decision would typically honor EMA’s advice.
However, it said that any approval would come with a safety monitoring plan, manufacturing controls, an investigation plan for use in children, and binding obligations by the manufacturers to provide more efficacy and safety data.
EMA said that its expert meeting was brought forward after firms provided more data at its request and that the EC promised to fast-track procedures to rule on approval “within days.”
According to EU member country Germany, it would begin giving jabs to Germans within three days upon the approval of the EU for the BioNTech-Pfizer vaccine. It said mass vaccination may begin as soon as Christmas.
In a joint statement, Germany along with Italy, France, and five other countries said that they would coordinate the start of their vaccination campaigns.
The countries said that they will promote “the coordination of the launch of the vaccination campaigns” and will rapidly share information on how it is proceeding, BBC’s report said, quoting the joint statement released by Italy.
The statement was also signed by the health ministers of Belgium, Luxembourg, the Netherlands, Spain, and EU neighbor Switzerland.
In a Twitter post, European Commission President Ursula von der Leyen said: “[It was] likely that the first Europeans will be vaccinated before end-2020.”
Britain was the first to approve the shot for the Pfizer-BioNTech vaccine on December 3, followed by Canada on December 9 and the US Food and Drug Administration (FDA) on December 11.
Photo from Flickr