The application of Regulation 536/2014 to COVID-19 vaccines
7.12.2021
Priority question for written answer P-005425/2021
to the Commission
Rule 138
Michèle Rivasi (Verts/ALE)
According to data from December 2021 available on the ClinicalTrials.gov site of the United States National Institutes of Health, the end date of the clinical study (phases 1, 2 and 3) estimated by Pfizer / Biontech for the Comirnaty vaccine is 2 May 2023[1], and for Moderna’s mRNA-1273 vaccine the date is 27 October 2022[2]. According to the same source, this end date is 14 February 2023 for the AstraZeneca vaccine[3] and 2 January 2023 for the Janssen vaccine[4].
Given that these vaccines in the clinical study phase have received conditional marketing authorisation in the EU, can the Commission confirm that the provisions of Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use (in particular, regarding informed consent) remain applicable to the four aforementioned vaccines as long as clinical trials continue, even after conditional marketing authorisation has been granted in accordance with Regulation (EC) No 726/2004 of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency?