In June 2006 the US Food and Drug Administration is expected to approve a human papilloma virus (HPV) vaccine which is over 90% effective in preventing new infections and precancerous cervical lesions caused by the HPV types that it covers.1,2 The vaccine prevents cancer through preventing sexual transmission of HPV types that cause cervical cancer.3 This link to a sexually transmitted infection raises ethical concerns that must be resolved if the benefits of preventing cancer are to be realised.
The vaccine must be given before HPV infection is acquired. It is most likely to be recommended for 11-12 year olds, because by the ninth grade (age 14-15) 28% of girls in the US are sexually active. This has prompted some advocates of premarital abstinence to charge that HPV vaccination will condone or promote sexual promiscuity. However, its impact will probably be small because multiple factors are associated with initiation of sexual activity; fear of sexually transmitted infections is not a major reason for abstinence, and condom availability programmes have not been associated with behavioural disinhibition.4
For adolescents aged under 18 medical interventions, including vaccinations, generally require informed consent from both the parents and the adolescent.5 Thus several possible combinations of decisions about HPV vaccination exist. If both parent and adolescent agree to the vaccine there are no ethical problems. In surveys, about 75% of well informed parents say they would accept the vaccine.6 Some parents would refuse because they believe the child is not sexually active; if they were to agree at a later age, cumulative uptake would be even higher. Little is known about adolescents' attitudes to the vaccine. If both parent and adolescent refuse the vaccine, the physician can try to educate and persuade them. Coerced vaccination is not justified because there is no public health emergency. Similarly, forcing an intervention over an adolescent's objections is not justified because it fails to respect the adolescent as a maturing individual.7
The most controversial situation is when an adolescent seeks the vaccine without parental permission. The parents might have refused, or the adolescent might not want to discuss her sexual activity with her parents. Furthermore, some parents do not act in the child's best interests, as in cases of abuse. In most US states adolescents may obtain treatment on their own for sexually transmitted infections, contraception, and pregnancy because requiring parental permission might deter them from seeking treatment for these important health problems.8 In these conditions, the adolescent's wellbeing and growing self determination are considered to outweigh the right of parents to make decisions on behalf of children and to shape their values.9
Proponents of HPV vaccine might advocate public health policies that increase its uptake, such as requiring vaccination as a condition of entry into middle school. However, the rationale for mandatory vaccination is weaker for HPV than for childhood infections because HPV is not contagious; it is transmitted only by unprotected intercourse. Moreover, because of parental opposition to other vaccines, most states allow exceptions to required childhood vaccinations before school enrolment.10 Another approach is making HPV vaccine “routine” for adolescents—that is, giving it without extensive discussion or affirmative consent unless the parent or child objects. Such a policy, which effectively ignores the concerns about HPV vaccine, may be short sighted and could increase opposition.
Conservative “pro-family” organisations and others who are concerned about the vaccine's potential impact on sexual behavior seek parental choice regarding HPV vaccine. Although HPV vaccine raises some similar issues as abortion, it need not be as contentious. Unlike abortion, HPV vaccine cannot be considered morally wrong per se: its long term goal is cancer prevention, an undisputable benefit. The point of the vaccine is to give it before sexual activity starts. Objections might be addressed by linking administration of HPV vaccine without parental permission to programmes that facilitate parent-adolescent communication and counsel adolescents about risky behaviour.
The HPV vaccine is most needed in resource poor countries, where cervical cancer takes a particularly heavy toll and where cancer screening is lacking.11 In these countries, the projected US price of $300 (£171; €246) or more is unaffordable, and a series of three injections (as proposed in the US regimen), may not be feasible. Thus a global programme will require research to develop single dose vaccines, international assistance for vaccine financing and delivery, and negotiations on two tier pricing.
HPV vaccine is not a magic technological bullet. Decisions about HPV vaccine will be made in the context of organised opposition to childhood vaccines, allegations that vaccine risks are downplayed, mistrust towards physicians and drug manufacturers, disagreements over childrearing and sexuality, and inaccurate information on the internet. Transparent policies that acknowledge disagreements and uncertainties regarding HPV vaccine will build trust and support for it as well as for other programmes to promote adolescent health.
BL is supported by the Greenwall Foundation and by NIH grants P30 MH062246, K12 HD049077, and U01 AI46749.
Competing interests: BL is a member of a data and safety monitoring board for a clinical trial of an HIV vaccine, sponsored jointly by the National Institutes of Health and by Merck.
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