Document Detail

FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP).
MedLine Citation:
PMID:  20508594     Owner:  NLM     Status:  MEDLINE    
On October 16, 2009, the Food and Drug Administration licensed quadrivalent human papillomavirus vaccine (HPV4; Gardasil, Merck & Co. Inc.) for use in males aged 9 through 26 years for prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. HPV4 had been licensed previously for use in females aged 9 through 26 years for prevention of HPV 6, 11, 16, and 18-related outcomes (i.e., vaginal, vulvar, and cervical precancers and cancers and genital warts). The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of females at age 11 or 12 years and catch-up vaccination for females aged 13 through 26 years. On October 21, 2009, ACIP provided guidance that HPV4 may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts; ACIP does not recommend HPV4 for routine use among males. This report presents the ACIP policy statement and summarizes background data. Issues reviewed by ACIP included efficacy, immunogenicity, and safety of the HPV4 vaccine in males, epidemiology of HPV and burden of HPV-associated diseases and cancers in males, cost-effectiveness of male vaccination, and programmatic considerations.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  MMWR. Morbidity and mortality weekly report     Volume:  59     ISSN:  1545-861X     ISO Abbreviation:  MMWR Morb. Mortal. Wkly. Rep.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-28     Completed Date:  2010-06-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7802429     Medline TA:  MMWR Morb Mortal Wkly Rep     Country:  United States    
Other Details:
Languages:  eng     Pagination:  630-2     Citation Subset:  IM    
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MeSH Terms
Advisory Committees
Clinical Trials as Topic
Condylomata Acuminata / prevention & control*
Human papillomavirus 11*
Human papillomavirus 6*
Immunization Schedule
Papillomavirus Infections / prevention & control*
Papillomavirus Vaccines / administration & dosage*,  adverse effects,  contraindications,  immunology
United States
United States Food and Drug Administration
Young Adult
Reg. No./Substance:
0/Papillomavirus Vaccines; 0/human papillomavirus vaccine L1, type 6,11,16,18

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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