A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD.
GARDASIL has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. It is therefore essential to assess its impact and safety through post-licensure surveillance programs. Here, we present a summary of 16 post-licensure safety and impact studies across 20 countries. These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al.
Bonanni
Paolo
P
University of Florence, Florence, Italy.
Cohet
Catherine
C
Kjaer
Susanne K
SK
Latham
Nina B
NB
Lambert
Paul-Henri
PH
Reisinger
Keith
K
Haupt
Richard M
RM
D000293:Adolescent; D000328:Adult; D001291:Attitude of Health Personnel; D002648:Child; D002986:Clinical Trials as Topic; D003218:Condylomata Acuminata / Q000453:epidemiology / Q000517:prevention & control; D004345:Drug Industry; D005060:Europe; D005260:Female; D005602:France; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008004:Licensure; D008329:Managed Care Programs; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D010342:Patient Acceptance of Health Care; D011358:Product Surveillance, Postmarketing; D012042:Registries; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control; D055815:Young Adult
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines