Practice Alert

HPV vaccine is now routinely indicated for males

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References

TABLE 2
A look at the human papillomavirus vaccines
3

Quadrivalent (Gardasil)Bivalent (Cervarix)
Manufacturer/VLP typesMerck/6, 11, 16, 18GlaxoSmithKline/16, 18
Date of US licensure2006, females
2009, males
2009, females
Dose of protein20/40/40/20 μg20/20 μg
Producer cellsSaccharomyces cerevisiae (yeast)Baculovirus-infected Trichoplusia ni (insect cell line)
AdjuvantAAHS: 225 μg amorphous aluminum hydroxyphosphate sulfateAS04: 500 μg aluminum hydroxide; 50 μg 3-O-desacyl-4’-monophosphoryl lipid A
Schedule (IM)3-dose series3-dose series
VLP, virus-like particle; IM, intramuscular.

HPV vaccine is effective, but costly

A major consideration with HPV vaccines is their cost. With 3 doses required and each dose costing about $130,9 cost effectiveness is poor when preventing uncommon diseases such as cervical and anal cancer, and a relatively benign disease such as genital warts. Male vaccination at age 12 years, when added to a female vaccination program, costs about $20,000 to $40,000 per quality-adjusted life year (QALY) if all potential HPV morbidity is included, not just that which has been proven to be prevented by the vaccine (assuming oral and penile cancer will also be prevented). Counting only HPV disease demonstrated to be prevented by the vaccine, the result is $75,000 to $250,000+ per QALY.6 Vaccinating males older than 21 years results in a cost per QALY 2 to 4 times that of vaccinating males younger than 18 years.10

A final decision. After considering these factors, ACIP approved a set of recommendations at its October 2011 meeting that will become official once they are published in the Morbidity and Mortality Weekly Report. (See “ACIP recommendations for HPV vaccine use in males”.)

ACIP recommendations: HPV vaccine use in males
  1. Routinely vaccinate males ages 11 to 12 years with 3 doses of HPV4. The vaccination series can be started at 9 years of age. (A recommendation)
  2. Vaccinate males, ages 13 to 21 years, who have not been vaccinated previously or who have not completed the 3-dose series. (A recommendation)
  3. Consider vaccinating males ages 22 to 26 years. (B recommendation)
  4. Vaccinate men ages 22 to 26 years of age who have sex with men and those in this age group who are HIV positive, if they have not been previously vaccinated. (A recommendation)

Levels of recommendation

A: Applies to all individuals in an age- or risk factor-based group.
B: Defers to clinician judgment in determining benefit for individuals.

Source: ACIP meeting; October 25, 2011; Atlanta, Ga.

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