In France, this Thursday December 24, 2020 the Haute Autorité de Santé has handed its verdict as to the issuing of the Pfizer/BioNTech vaccine. The health authorities give the green light and allow the vaccine campaign to start from Sunday December 27, 2020 in France.
Three days ago, the EMA – European Medicines Agency – has approved the issuance of the Pfizer/BioNTech vaccine which applications have been examined for several weeks. Yet, there is one condition for issuance: the vaccine shall be reserved to people over 16 years old. Approval was first expected to be delivered on December 29, but has been brought forward after Germany put pressure on the European Union for a quicker approval.
“I'm delighted to be here and to announce that that EMA Scientific Committee met today and recommended a conditional marketing authorization in the EU for the vaccine developed by BioNTech and Pfizer,” Emer Cooke, the EMA executive director, said. She went on: "We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States. Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards."
Set in Amsterdam, this agency entrusted with – a bit like the American FDA (Food and Drug Administration) – approving and controlling the issuance of medicines within the European Union. Validation prior authorization to be issued on the market, as provided by the European Commission. Note that the EMA also created an accelerated procedure to manage issuance applications, enabling to “to assess data as it becomes available throughout the ongoing research and development stages and before manufacturers formally apply for a review”.