Extraction of a sixth dose from Pfizer-BioNTech vaccine vials

29.1.2021

Question for written answer  E-000571/2021
to the Commission
Rule 138
Antoni Comín i Oliveres (NI)

Information has recently come to light about the possibility of extracting six doses, instead of five, from each vial of the tozinameran vaccine produced by Pfizer/BioNTech. On Friday 8 January 2021, the European Medicines Agency (EMA) recommended that Pfizer include information on the possible use of this sixth additional dose, which can only be extracted with specific syringes. These syringes have also been approved by the EMA.

Some Member States, e.g. Spain, have not received enough of these specific syringes.

• 1.The only advanced purchase agreement we have been able to consult states that purchases are by dose. Why did the Commission purchase doses, and not vials?
• 2.Why did the Commission not clarify, before concluding the contract with Pfizer/BioNTech, that six doses could be extracted from each vial of the tozinameran vaccine? Did Pfizer/BioNTech decide to decrease the number of deliveries planned for each period after the EMA recommended including information on using the sixth dose?
• 3.If it did decrease the number of deliveries, why did the Commission and the contractor not reach an agreement to maintain the initial delivery schedule by having the Commission pay the difference corresponding to the extra doses extracted per vial, so that the total number of doses could be delivered sooner?