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Written question asked by Countess of Mar (Crossbench) on Tuesday, 7 July 2015, in the House of Lords. It was due for an answer on Tuesday, 21 July 2015. It was answered by Lord Prior of Brampton (Conservative) on Monday, 20 July 2015 on behalf of the Department of Health.

Human Papillomavirus: Vaccination

Question

To ask Her Majesty’s Government whether post-marketing surveillance has been conducted on the administration of (1) Gardasil, and (2) Cervarix; if so, by whom, over what period, and with what results; and if not, why not.

Answer

All licensed medicines and vaccines, including Gardasil and Cervarix, are subject to post-marketing surveillance (also known as pharmacovigilance). Gardasil and Cervarix are authorised via the centralised procedure with the European Commission as Licensing Authority. The post-marketing surveillance for centrally authorised products is underpinned by European Legislation (Regulation (EU) No 1027/2012) which puts requirements on national competent authorities in member states, the European Medicines Agency and marketing authorisation holders to collect data on safety of medicines and vaccines, assess any new issues, take action to minimise risks and monitor the effectiveness of any action taken.

Gardasil and Cervarix have been subject to post-marketing surveillance since the time of marketing. Gardasil and Cervarix have a very good safety record, and surveillance shows they have contributed to a significant decrease in rates of infection with the two main cancer-causing human papillomaviruses. The United Kingdom programme is eventually expected to prevent hundreds of deaths from cervical cancer every year.

Secondary information

Type
Written question
Reference
HL1162
Session
2015-16
Subjects
Vaccination Side effects Human papillomavirus
Contains statistics
Yes
Link
View this Written question on www.parliament.uk