In men, some human papillomaviruses (HPVs) cause anal, oropharyngeal and penile cancers. Anal cancers are more common in men who have sex with men, particularly if they are HIV seropositive. In France, HPV vaccination is recommended for all males aged 11 to 19 years and for those under 27 years of age who have sex with men. What is the harm-benefit balance of this vaccination strategy, at both the individual and population level? To answer this question, we reviewed the available evidence using the standard Prescrire methodology. In a randomised trial in about 4000 young men, about 15% of whom had sex with men, those who had received at least one injection of human papillomavirus vaccine 6,11,16,18 had a lower incidence of certain types of anogenital warts: 1.6% versus 4.3% among the men in the placebo group, after a follow-up of about 3 years. In this trial, among the 602 participants not infected with HIV who stated they had sex with men and agreed to be screened for anal cancer, no cases of anal cancer were reported, as would be expected with such a short observation period. There were 18 cases of high-grade dysplasia in the vaccine group, versus 39 in the placebo group. In a trial in men over 26 years of age who had sex with men and were infected with HIV, the vaccine had no preventive effect against high-grade anal dysplasia. Our literature search identified no comparative trials that evaluated HPV vaccines in the prevention of oropharyngeal cancer. The epidemiological data amassed over approximately 15 years of use of HPV vaccines in young women suggest that it reduces the incidence of cervical cancer in vaccinees. In countries that have chosen to extend HPV vaccination to men, longer-term data will be required to determine the effect of this strategy on HPV transmission and the incidence of premalignant lesions and cervical cancer in women. Like other vaccines, HPV vaccines can cause injection site reactions and pain, syncope and, very rarely, anaphylactic reactions. An increased risk of Guillain-Barré syndrome has not been ruled out; the incidence could be somewhere between one case in 100 000 and one in 1 million vaccinees. Based on the data available in early 2021, the 9-valent HPV vaccine probably has a favourable harm-benefit balance in men who are at highest risk of developing HPV-related cancer, mainly men who are starting to or might have sex with men. Vaccinating all 11- to 19-year-old males is a reasonable gamble, though its harm-benefit balance is less well established than a strategy targeting men at high risk.
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