Written question – EMA’s role in COVID-19 vaccine approval procedures, inspections and good clinical practice checks – P-001695/2025

Priority question for written answer  P-001695/2025
to the Commission
Rule 144
Friedrich Pürner (NI)

A recently published investigation by a German newspaper[1] has revealed that the European Medicines Agency (EMA) omitted or avoided crucial checks to test for side effects during the approval procedures for COVID-19 vaccines. Statutory good clinical practice checks by inspectors to review manufacturers’ clinical studies either did not take place or were limited in scope.

• 1.Was the Commission aware of what happened? If so, when did it become aware and why did it not intervene?
• 2.What inspection rules are in place for emergency use authorisation – particularly with regard to studies in non-EU countries – to make sure medicines are safe, the duty of care is upheld and patients are protected?
• 3.Was the Commission informed by the EMA about occurrences of myocarditis (inflammation of the cardiac muscle) in Israel? If so, when (what date) and by whom (names of those involved), and how did the Commission handle this information on safety signals after mRNA vaccines were administered?

Submitted: 28.4.2025

• [1] https://www.welt.de/politik/plus256010158/Impfstoff-Kontrollen-Das-war-politisch-nicht-gewuenscht.html