See question(s) :E-004563/2021
Answer given by Ms Kyriakides
on behalf of the European Commission (6.1.2022)
The authorisation of clinical trials in the EU is Member State responsibility after scientific and ethics assessment by national competent authorities and ethics committees to ensure participants’ protection and that the anticipated benefits exceed the risk for participants12. Clinicaltrial data is necessary to grant a marketing authorisation for a specific age group. In the case of Pfizer’s COVID-19 vaccine, a paediatric investigation plan (PIP), including children from birth, was agreed by the European Medicines Agency (EMA)3.
Clinical data in the marketing authorisation, including results as agreed in the PIP, are published after marketing authorisation. The PIP, including waivers and deferrals for publication, is assessed by EMA’s Paediatric Committee. EMA also publishes product information with trial results, the European Public Assessment Report after EU marketing authorisation and the Risk Management Plans for COVID-19 products.
Protocol and results related information of clinical trials in the EU need to be published within six months after the end of paediatric trials in the EU Clinical Trials Register. Clinical trial data throughout the life-cycle of the trial will be published under the Clinical Trials Regulation.
For medical devices the sponsors of clinical investigations will publish the clinical investigation report and its summary in Eudamed4. For in vitro diagnostic medical devices (IVD) the sponsors of performance studies will publish the performance study report and its summary. For class III and implantable devices, and class C and D IVDs, a Summary of Safety and Clinical Performance and a Summary of Safety and Performance respectively will be published.
1OJ L 121, 1.5.2001, p. 34. https://ec.europa.eu/health/documents/eudralex/vol-1_enhttps://ec.europa.eu/health/sites/default/files/files/eudralex/vol- 1/dir_2001_20/dir_2001_20_en.pdf (EU Commission link incorrect)
2OJ C 44, 15.2.2013, p. 99. https://ec.europa.eu/health/sites/default/files/files/eudralex/vol- 1/reg_2014_536/reg_2014_536_en.pdf (EU Commission link incorrect)
4Article 77 (5) of Regulation (EU) 2017/745 on medical devices, https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A02017R0745-20200424 (EU Commission link incorrect)
Source – EU Parliament: Answer to a written question – A recent Pfizer publication shows that it conducts clinical trials of COVID-19 vaccines on children, even children under five years of age – E-004563/2021(ASW)