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| ISV Paper of the Month |
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February 2011 |
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Efficacy of quadrivalent HPV vaccine against HPV
infection and disease in males |
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Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone,
Edson D. Moreira, Jr., Mary E. Penny, Carlos Aranda, Eftyhia Vardas, Harald Moi,
Heiko Jessen, Richard Hillman, Yen-Hwa Chang, Daron Ferris, Danielle Rouleau, Janine
Bryan, J. Brooke Marshall, Scott Vuocolo, Eliav Barr, David Radley, Richard M. Haupt
and Dalya Guris |
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The New England Journal of Medicine, Feb 3, 2011, 364(5):401-411 |
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Related “Perspective” from Dr. Jane J. Kim |
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Weighing the benefits and costs of HPV vaccination of young men |
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The New England Journal of Medicine, Feb. 3, 2011, 364(5):393-395 |
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“Though the evidence regarding the efficacy of the HPV
vaccines to this point has centered on the prevention of HPV infection and diseases
in girls and women, the data presented by Giuliano et al. in this issue of the Journal
(pages 401–411) affirm the potential for HPV vaccines to prevent related disease
in boys and men. The investigators report the efficacy of the quadrivalent HPV vaccine
in preventing infections with the HPV types included in the vaccine, as well as
external genital lesions, primarily genital warts, in young men 16 to 26 years of
age.” |
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“These data informed the 2009 approval by the Food and Drug Administration (FDA)
of the quadrivalent HPV vaccine for the prevention of genital warts in young men
in the United States and the subsequent recommendation from the Advisory Committee
on Immunization Practices (ACIP), which advises the Centers for Disease Control
and Prevention (CDC), for the permissive use of the vaccine in boys and young men
9 to 26 years of age. The ACIP stopped short of supporting routine HPV vaccination
of adolescent boys, even though routine vaccination of girls between the ages of
11 and 12 years (and as early as 9 years) has been recommended since 2007. However,
the committee did recommend financial coverage by the CDC Vaccines for Children
program for eligible boys 18 years of age or younger. Since these decisions were
made, newer data have shown that the quadrivalent HPV vaccine is effective in preventing
anal intraepithelial neoplasia, a precursor to anal cancer, in men, particularly
in men who have sex with men. Q, the basis of this new evidence, the FDA recently
approved the expanded use of the quadrivalent vaccine to include the prevention
of anal lesions and cancer in people of both sexes, a decision that has reignited
the debate over routine HPV vaccination of young men.” |
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“The report by Giuliano et al. undoubtedly gives us cause to celebrate the extraordinary
potential for HPV vaccination to improve health in both women and men. And although
enthusiasm for universal vaccination may initially be tempered by uncertainties
about the vaccine’s safety, efficacy, and duration of protection (as well as its
uptake, acceptability, and cost), many of these factors could very well change in
the future. For example, the cost effectiveness profile of routine vaccination of
young men will improve if the evidence of efficacy continues to mount, the vaccine
price declines, or coverage among girls and women remains low.” |
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