Excipients ALC-0315 and ALC-0159

22.12.2021

Priority question for written answer  P-005690/2021
to the Commission
Rule 138
Guido Reil (ID)

According to the product information supplied by the European Medicines Agency, two of the main components of Pfizer’s Comirnaty vaccine are ALC-0315 and ALC-0159. Echelon, the manufacturer of these nanoparticles, specifies that they are ‘for research only and not for human use’. Administering a vaccine – particularly to children – which contains unauthorised excipients is illegal, dangerous and unethical.

• 1.How does the Commission justify distributing a product that is harmful to public health and, as such, infringes Article 168(1) of the Treaty on the Functioning of the European Union?
• 2.How can it explain such a serious oversight – particularly given that the EU founded a European Health Emergency Preparedness and Response Authority (HERA) in September 2021 – and how will it avoid similar occurrences in future?
• 3.What does it intend to do to put an end to the persistent threat that unauthorised vaccine components pose to people in Europe?