TITLE

FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (ACIP)

PUB. DATE
May 2010
SOURCE
MMWR: Morbidity & Mortality Weekly Report;5/28/2010, Vol. 59 Issue 20, p630
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article provides information on the licensure of quadrivalent human papillomavirus vaccine (HPV4), Gardasil from Merck & Co. Inc. by the U.S. Food and Drug Administration (FDA) for use in males to prevent genital warts caused by HPV 6 and HPV 11. The Advisory Committee on Immunization Practices (ACIP) provided guidance on the efficacy, immunogenicity, and safety of the HPV4 vaccine in males, among others. In the clinical trials for men, injection-site reactions were found to be the most common adverse events.
ACCESSION #
51310418

 

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