Source: European Parliament
Priority question for written answer P-000624/2025
to the Commission
Rule 144
Christine Anderson (ESN)
The unredacted Advance Purchase Agreement (APA) for the development, production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member States has now been published online[1].
I quote from Annex I (Vaccine Order Form), Article I(4), page 49: ‘Further, to the extent applicable, the Participating Member State acknowledges that the Vaccine shall not be serialized’.
The term ‘serialise’ typically refers to the process of uniquely identifying each vaccine dose or package with a distinct identifier, such as a serial number, barcode or QR code.
By waiving the serialisation of the vaccine, the APA, as negotiated by the Commission, has made it impossible to uniquely identify each dose and track it from production to delivery and eventual administration.
- 1.What is the reason for this, other than to create obstacles to being able to hold Pfizer liable in the event of sub-standard vaccines?
- 2.How is this compliant with the Falsified Medicines Directive[2], which mandates the serialisation of medicinal products?
- 3.Did the Commission not see how not serialising the vaccine would create difficulties for tracking, tracing and monitoring vaccine distribution and administration, managing inventory levels, gathering and sharing information, ensuring accountability, and recalling the product, especially in the light of the fact that this was a largely untested product that was destined to be administered to hundreds of millions of EU citizens?
Submitted: 11.2.2025
- [1] https://archive.org/details/contract_03.
- [2] Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 174, 1.7.2011, p. 74, ELI: http://data.europa.eu/eli/dir/2011/62/oj.