Cervarix licence extended

1 October 2010

The marketing authorisation for Cervarix has been updated to show that it offers broader protection against human papillomavirus (HPV) than first thought.

Cervarix was launched in the UK in 2007.

Cervarix was originally indicated to protect against only the two HPV types it contains—16 and 18—which are collectively responsible for around 70 per cent of all cervical cancer cases. Now, however, its licence has been amended to indicate that the vaccine also provides cross-protection against strains 31, 33 and 45—accounting for a further 10 per cent of cases.

The licence update is based on an analysis of the international Phase 3 PATRICIA study, which assessed the efficacy of Cervarix in over 16,000 women aged 15–25 years.

Gardasil, the other HPV vaccine licensed in the UK, has previously been shown to provide cross-protection against ten HPV strains in addition to the four it contains (6, 11, 16 and 18)