Important UPDATED Information on the Merck HPV Vaccine Gardasil – From the New England Journal of Medicine
Posted by Catherine Morgan on May 15, 2007
Important UPDATED Information on the HPV Vaccine Gardasil – From the New England Journal of Medicine
The New England Journal of Medicine has a new report out on the Gardasil vaccine. Here are some excerpts from this report…
What can be inferred from these data about the potential effect of vaccination among girls 11 and 12 years of age? The FUTURE trials did not enroll subjects in this age group. Within both trials, subgroups of subjects with no evidence of previous exposure to relevant vaccine HPV types were evaluated separately for vaccine efficacy. In these subgroups, efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types was reported in both trials. However, it would be important to know the overall rates of grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ regardless of HPV types. Without these data, it is difficult to infer both the effectiveness of vaccination and the role of nonvaccine HPV types in overall rates of preinvasive lesions.
What do these results mean for cervical-cancer screening? Screening should continue in all vaccinated women, given the cumulative lifetime risk of exposure to other oncogenic HPV types and the unknown duration of anti-HPV immunity. The effect of vaccination on cervical cytologic findings was not reported in either trial, but if vaccination reduces the rates of abnormal findings, this benefit would be important. Of note, a trial of a monovalent HPV-16 vaccine reported no effect on cytologic abnormalities.12
Policymakers, clinicians, and parents have a keen sense of urgency about HPV vaccination. On one hand, the vaccine has high efficacy against certain HPV types that cause life-threatening disease, and it appears to be safe; delaying vaccination may mean that many women will miss an opportunity for long-lasting protection. On the other hand, a cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time. HPV vaccination has the potential for profound public health benefit if the most optimistic scenario of effectiveness is realized.