Finally! HPV male shot routinely recommended

The Advisory Committee on Immunization Practices (ACIP) has voted to recommend that males be routinely vaccinated against human papillomavirus (HPV), a move many public health officials seeing as a boost for use of the shot.

In June 2006, the ACIP recommended HPV vaccine for 11- to 12–year–old girls and also for teen girls and young women through age 26 who had not already received the vaccine. In October 2009, the quadrivalent HPV vaccine (Gardasil, Merck & Co.) also was approved for use in boys and young men. However, the prior ACIP recommendation for males was a permissive one, and very few boys or young men received the vaccine with the permissive recommendation, says Joseph Bocchini Jr., MD, chairman of the Department of Pediatrics at Louisiana State University Health Sciences Center in Shreveport, LA, and chair of the ACIP Working Group on HPV Vaccines.

By making the male HPV vaccine a routine recommendation, it will enable clinicians and patients, or clinicians and parents of younger males, to be able to talk about the benefits of the vaccine, says Bocchini. The fact that it is routinely recommended will aid in rapid uptake of the vaccine, he notes.

The recommendation becomes official with its publication as a policy note in the Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report (MMWR). The publication date had not been announced by Contraceptive Technology Update's press time.

"ACIP recommendations carry great weight with healthcare providers, who in turn influence parents looking for guidance," said Deborah Arrindell, vice president for health policy with the Research Triangle Park, NC-based American Social Health Association in a press statement following the committee meeting. "This is a public health victory we've long been seeking."

Who should get shot?

ACIP has recommended routine vaccination of males ages 11 or 12 with three doses of the quadrivalent HPV vaccine. The recommendation includes wording that vaccination can begin as young as age 9, and that boys and young men ages 13 to 21 who have not already received the vaccine also should be immunized. The second dose should be administered one to two months after the first dose, and the third dose should be administered six months after the first dose. The quadrivalent vaccine is given to prevent genital warts and anal cancer in males.

The ACIP recommendation came from a careful review of data, much of which became available after the initial permissive recommendation in 2009. The new data included results from clinical trials indicating the effectiveness of the quadrivalent HPV vaccine in males.1 Data indicate the greatest impact can be had when the vaccine is given at ages 11 or 12, where there is a better immune response compared with older ages.2 The vaccine is most effective when it is given before there is exposure to the virus, which occurs through sexual contact; this led to the rationale for recommending routine vaccine use in 11- or 12–year–old males.

Research continues in use of the quadrivalent vaccine in men who have sex with men. A just-published study indicates use of the quadrivalent vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men.3

Vaccine safety affirmed

In looking at routine recommendation of males, ACIP members also reviewed of data on vaccine safety. Through September 2011, nearly 40 million doses of HPV vaccine have been distributed in the United States. Results of clinical trials indicate the quadrivalent HPV vaccine is safe for males as well as for females.4. The most common adverse events or side effects that can occur following HPV vaccination include injection site reaction, headache and fever; those reactions have tended to be mild or moderate in intensity.4

Andrew Bonwit, MD, pediatric infectious disease specialist at Loyola University Health System in Chicago, says that it is important for clinicians to review the most current ACIP information before recommending or administering any vaccinations to be properly informed about the appropriateness, benefits, guidelines, and risks involved. (To review the ACIP recommendations, go to its web site www.cdc.gov/vaccines/recs/acip. Select "ACIP Recommendations.")

"There are very few risks associated with the male HPV vaccine," says Bonwit.

Will there be an increase?

Coverage rates have increased each year since the HPV vaccine was approved in 2006. In 2010, overall coverage among girls ages 13-17 was 48.7% for one or more doses, and overall coverage was 32.0% for three doses.5 However, while rates for three vaccines given during adolescence -— meningococcal conjugate; tetanus, diphtheria, acellular pertussis; and HPV — have grown, rates of HPV vaccine coverage have lagged behind the other two.6

It is still early to determine uptake of the HPV vaccine among males. However, research indicates that men might be more willing to receive vaccination when they learn it can prevent cancer.7

Will price preclude some males from receiving the vaccine? As of July 2011, the CDC reported the retail price of the vaccine at about $130 per dose, or $390 for the full series. The publicly funded Vaccines for Children program provides vaccine at no charge to children ages 18 years or younger who are uninsured or meet eligibility criteria; the quadrivalent vaccine is included in that program. The benefit for Medicaid-eligible children becomes effective 90 days after establishment of the vaccine schedule in the MMWR.

References

  1. Markowitz L. HPV vaccine for males background and review of data. Presented at the Advisory Committee on Immunization Practices (ACIP) meeting. Atlanta; October, 2011.
  2. Dunne E. HPV vaccine considerations for males. Presented at the Advisory Committee on Immunization Practices (ACIP) meeting. Atlanta; October, 2011.
  3. Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. NEJM 2011; 365:1,576-1,585.
  4. Gee J. Safety of quadrivalent human papillomavirus (HPV4) vaccine. Presented at the Advisory Committee on Immunization Practices (ACIP) meeting. Atlanta; October, 2011.
  5. Centers for Disease Control and Prevention. National and state vaccination coverage among adolescents aged 13 through 17 years — United States, 2010.
  6. Centers for Disease Control and Prevention (CDC). National and state vaccination coverage among adolescents aged 13 through 17 years — United States, 2010. MMWR 2011; 60:1,117-1,123.
  7. McRee AL, Reiter PL, Chantala K, et al. Does framing human papillomavirus vaccine as preventing cancer in men increase vaccine acceptability? Cancer Epidemiol Biomarkers Prev 2010; 19:1,937-1,944.