38833 - Human Papillomavirus: Vaccination (Answered)

Andrew Gwynne
To ask the Secretary of State for Health, whether the Medicines and Healthcare Products Regulatory Agency holds any clinical trial data for HPV vaccines which is not in the public domain.

George Freeman

There are two human papilloma virus vaccines licensed in the European Union: Cervarix and Gardasil 9. These products are licensed centrally throughout Europe by the European Commission via the European Medicines Agency (EMA). Applicants for centrally authorised products are required to submit all relevant supporting clinical trials data, whether published or not, to the EMA directly and not to the Medicines and Healthcare products Regulatory Agency.

Under current medicines legislation, the EMA database registers all EU-approved clinical trials of investigational medicinal products. Since March 2011 this information has been publicly accessible through the EU Clinical Trials Register (except adult Phase 1 trials). The EU Clinical Trials Register includes all EU-conducted trials since May 2004 when the Clinical Trials Directive was implemented and can be found here:

https://www.clinicaltrialsregister.eu/ctr-search/search

Furthermore since July 2014 clinical trial sponsors have been required to provide a summary of their trial results uploaded onto the EU Clinical Trials Register within one year of their trial completing. There is a two year programme of back-loading underway to provide summaries of trial results for all trials on the Register back to when the EudraCT database was initiated in May 2004.