OBJECTIVE: To quantify the effect on cervical disease at age 20 years of immunisation with bivalent human papillomavirus (HPV) vaccine at age 12-13 years.
DESIGN: Retrospective population study, 1988-96.
SETTING: National vaccination and cervical screening programmes in Scotland.
PARTICIPANTS: 138 692 women born between 1 January 1988 and 5 June 1996 and who had a smear test result recorded at age 20.
MAIN OUTCOME MEASURES: Effect of vaccination on cytology results and associated histological diagnoses from first year of screening (while aged 20), calculated using logistic regression.
RESULTS: 138 692 records were retrieved. Compared with unvaccinated women born in 1988, vaccinated women born in 1995 and 1996 showed an 89% reduction (95% confidence interval 81% to 94%) in prevalent cervical intraepithelial neoplasia (CIN) grade 3 or worse (from 0.59% (0.48% to 0.71%) to 0.06% (0.04% to 0.11%)), an 88% reduction (83% to 92%) in CIN grade 2 or worse (from 1.44% (1.28% to 1.63%) to 0.17% (0.12% to 0.24%)), and a 79% reduction (69% to 86%) in CIN grade 1 (from 0.69% (0.58% to 0.63%) to 0.15% (0.10% to 0.21%)). Younger age at immunisation was associated with increasing vaccine effectiveness: 86% (75% to 92%) for CIN grade 3 or worse for women vaccinated at age 12-13 compared with 51% (28% to 66%) for women vaccinated at age 17. Evidence of herd protection against high grade cervical disease was found in unvaccinated girls in the 1995 and 1996 cohorts.
CONCLUSIONS: Routine vaccination of girls aged 12-13 years with the bivalent HPV vaccine in Scotland has led to a dramatic reduction in preinvasive cervical disease. Evidence of clinically relevant herd protection is apparent in unvaccinated women. These data are consistent with the reduced prevalence of high risk HPV in Scotland. The bivalent vaccine is confirmed as being highly effective vaccine and should greatly reduce the incidence of cervical cancer. The findings will need to be considered by cervical cancer prevention programmes worldwide.
Bibliographical noteThe manuscript was reviewed by Jo’s Trust, which supports the conclusions. It made the following statement: We think (it has) massive implications for the screening programme, vaccine and also impact on diagnoses in the future. It gives weight for activity to increase vaccine uptake, has implications on screening intervals. The clinically relevant herd protection is very interesting too. It also feeds into our policy calls for a new IT infrastructure (for the screening programme in England) to record and enable invitations based on whether someone has at the vaccine if intervals can be extended.
Funding: This study has been undertaken as part of the programme of surveillance of immunisation against human papillomavirus in Scotland, included within the routine work of Health Protection Scotland, a part of the Scottish National Health Service. No funding has been received from industry.
- HUMAN-PAPILLOMAVIRUS VACCINATION