HPV disease burden is enormous.
Cervical cancer is the major killer of women worldwide.
Oncogenic HPV is the necessary cause of cervical cancer.
The goal of primary prevention of cervical neoplasia is eradication of the disease.
Active follow-up durig the global phase III HPV vaccination eficacy trials has shown strikingly high efficacy against the best surrogate disease endpoint, CIN3.
Passive long-term follow-up based on population based cancer registries is needed to answer the question whether the high HPV vaccine efficacy translates into high efficacy against cervical cancer in real life.
The FUTURE trial (quadrivalent vaccine) population from Finland and the PATRICIA trial (bivalent vaccine) population from Finland were linked to the Cancer Registry of Finland. The trial populations included women enrolled in the vaccine arms, and matched unvaccinated control women not subject to any health care intervention.
The end-pont was CIN3+.
The mean follow-up was 5 years after the active follow-up had ended..
The pilot study based on the FUTURE trial demonstrated an incidence of zero in the vaccine arm, and an incidence of 115-116 in the placebo arm or in the unvaccinated control arm.
The corresponding incidence rates among the PATRICIA trial cohorts were 18 in the vaccinated arm, compared to 115 in the unvaccinated control women.
Thus, the vaccine efficacy was 84%.
Active follow-up of phase III trial populations has shown high vaccine efficacy against CIN3, the most stringent surrogate endpoint for cervical cancer.
Cancer registries and other health registries have an important role in monitoring the overall population impact of the HPV vaccines.
The first results from the long-term follow-up demonstrate high vaccine efficacy against CIN3+.
CIN3+ endpoint cases accumulate rapidly, and repeat registry linkage efforts will continue.