In describing an ethical evaluation of Australia's human papillomavirus vaccination program (HPVVP), Rae and Kerridge1 make a number of negative claims: that the program is associated with “highly selective framing and simplistic or emotional messages”, exaggerating risk perception; that it was introduced with unnecessary haste using a “prototype” vaccine; that many questions remain about HPV vaccine effectiveness; and that the need to respond to HPV infection and cervical cancer lacks urgency or necessity, and does not meet the condition of public justification.
We support exploring the ethical construct of immunisation programs, particularly if such assessments can assist in maximising public good. However, such evaluations should also avoid using selective language, and must give appropriate attention to all ethical issues. This HPVVP evaluation achieves neither.
The two HPV vaccines, registered for use in Australia by the Therapeutic Goods Administration, could not be reasonably described as ‘prototype’. The Australian Technical Advisory Group on Immunisation assessed both as suitable for inclusion on the National Immunisation Program. The initial rejection of CSL's application by the Pharmaceutical Benefits Advisory Committee (PBAC) is not, as the authors claim, noteworthy; this is common for eventually funded vaccines.2–5 After undertaking a cost-effectiveness assessment, PBAC advised, and the Commonwealth accepted, that the program be funded. If the authors have evidence that these systems lack integrity or are corrupt, they should provide it.
The authors highlight that most HPV infections are self-limiting with cancer resulting only from persistent high-risk strain infections – but this is the case regardless of the prevention strategy, including cervical screening. A majority of abnormalities detected by cervical smear resulting in treatment are similarly self-limiting and, even without treatment, will not develop into cervical cancer. This would not be a reasonable argument to use for the dismantling of population-based screening. Early Victorian data show that the HPVVP will reduce the burden of interventions required to respond to abnormalities detected via cervical screening.6
All vaccines have lower efficacy values in intention-to-treat analyses, as they include women HPV-16/18 positive at baseline, who have received even just a single dose of vaccine, and who may have presented for just one follow-up visit. Despite these features, the efficacy for preventing pre-cancer/cancer in the reference provided was still 44%.7 The lack of efficacy for already infected women has been clearly recognised, and formed part of the rationale for implementing a schoolgirl program in Australia, aiming to vaccinate the majority of females before sexual debut, thereby maximising effectiveness and coverage.
Rae and Kerridge state that HPV vaccination will provide only a small benefit to already screened women by reducing the absolute lifetime risk of cervical cancer from 0.86% to 0.30–0.47%, but this actually represents a 45–65% relative risk reduction. The risk reduction will be substantially higher in women who do not or cannot currently access cervical screening, including geographically remote and socioeconomically disadvantaged women,8 who are known to have a higher pre-vaccination era risk of cervical cancer.9 Early use of pneumococcal vaccine in Australian Indigenous children reduced globally-high disease rates so they matched non-Indigenous children within a few years,10 with this improvement persisting for vaccine-type disease. We would argue the HPVVP is the best public health tool to promote equity in cervical cancer prevention for all women.
Gender inequity is a pre-existing issue in cervical cancer epidemiology: men don't get it. Since HPVVP introduction there has been a 28% reduction in genital warts in heterosexual men who attend sexual health services,11 and modelling suggests that up to three-quarters of the maximum possible vaccination-conferred benefit to males will be achieved by the existing female-only program.12 Until males have HPV-related cancer rates similar to women, it is unlikely a male program would be cost-effective without a significant drop in the vaccine price.
National estimates for 2009 show that three-dose coverage for HPV vaccine in girls aged 15 years was 70.8%.13 This is a fantastic achievement, but leaves nearly one-third of girls with suboptimal protection. In 10, 20 or 30 years, there will be women with vaccine-type cervical cancer who, for whatever reason, did not receive HPV vaccine in adolescence. Any ethical evaluation should give due consideration to the devastating impact such missed opportunities will have.