Cervarix HPV vaccine: safety update at end of 4 years routine use in HPV immunisation programme

05 December 2012

Human papillomavirus (HPV) causes some common sexually transmitted diseases such as genital warts. Some types of HPV are also the main cause of cervical cancer. By immunising girls against HPV, up to 400 deaths from cervical cancer per year could be prevented.

Therefore a routine immunisation programme against HPV for girls aged 12 - 13 years, and a catch-up programme for girls aged 17 - 18 years was started across the UK in 2008. The HPV vaccine given was Cervarix.

In September 2012, Cervarix was replaced in the national HPV immunisation programme by another HPV vaccine called Gardasil▼. The MHRA and Commission on Human Medicines (CHM) performed a comprehensive ‘end of routine use’ review of all reports of suspected adverse reactions with Cervarix received since the start of its use in September 2008 up to 31st July 2012.

Over the four-year vaccination programme, more than 6 million doses of Cervarix have been given across the UK. The overall reporting rate of suspected adverse reactions was approximately 1 report per 1,000 doses, which is an expected reporting rate for a newly marketed vaccine with high exposure.

The number and nature of the suspected adverse reactions received was in line with expectations, and included reactions to the injection process (so-called ‘psychogenic reactions') rather than the vaccine itself. This end-of-use review supports the conclusions of earlier reviews that the balance of benefits and risks for Cervarix remains clearly positive.

This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).

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