Human papillomavirus immunisation programme: second year safety review

MHRA

Drug Safety Update

Article date: October 2010

Summary
No new risks have been identified for Cervarix despite significant exposure in the UK, and the balance of risks and benefits remains positive. This article summarises the safety experience of the past 2 years.

The human papillomavirus (HPV) immunisation programme has now completed its second successful year and is ready to enter its third. With at least 4·5 million doses of Cervarix administered up to  the end of July 2010 to girls aged 12–18 years across the UK, the vaccine has been shown to have an excellent safety profile. Most Yellow Card reports have related either to the signs and symptoms of recognised, minor side effects listed in the product information, or to the injection process and not the vaccine itself (ie, psychogenic in nature).

Safety monitoring strategy

Our proactive and transparent approach to safety monitoring for the HPV vaccine during its first 2 years of use has enabled real-time, scientifically robust analysis of vaccine safety. This strategy involved daily analysis of all suspected adverse reactions, and weekly publication of safety reports (see www.yellowcard.gov.uk and www.mhra.gov.uk/hpvvaccine). The approach has provided reassurance on events likely to be coincidental to the vaccine, and helped to minimise unfounded concerns among parents and teenagers. As with all vaccines and medicines, the MHRA will continue to keep the safety of Cervarix vaccine under close review.

Cervarix: current safety profile

Up to the end of July 2010, we received 4703 Yellow Cards, including 10,410 adverse-reaction terms, in association with Cervarix (including reports in which the brand of HPV vaccine was not stated by the reporter). The reporting profile is very much in line with that of the first year of the programme (see Drug Safety Update October 2009), and the total number of reports received over the past 2 years of the programme is consistent with that expected.

See Chart…