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An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015

Título de la revista
Vichnin, Michelle
Bonanni, Paolo
Klein, Nicola P.
Garland, Suzanne M.
Block, Stan L.
Kjaer, Susanne K.
Sings, Heather L.
Perez, Gonzalo
Haupt, Richard M.
Saah, Alfred J.



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Lippincott Williams and Wilkins


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Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. Methods: Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus). Results: We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates. Conclusions: These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination. Copyright © 2015 Wolters Kluwer Health, Inc.
Palabras clave
Wart virus vaccine , Postmarketing , Anaphylaxis , Anus cancer , Autoimmune disease , Cerebrovascular accident , Clinical protocol , Clinical trial (topic) , Drug safety , Drug surveillance program , Faintness , Genital system , Guillain Barre syndrome , Human , Human immunodeficiency virus infected patient , Incidence , Licensing , Pharmacoepidemiology , Precancer , Pregnant woman , Priority journal , Public health , Review , Skin infection , Systemic lupus erythematosus , Uterine cervix cancer , Vaccination , Vagina cancer , Venous thromboembolism , Verruca vulgaris , Vulva cancer , Adolescent , Adult , Child , Drug-Related Side Effects and Adverse Reactions , Female , Male , Middle aged , Papillomavirus Infections , Pathology , Postmarketing surveillance , Pregnancy , Young adult , Adolescent , Adult , Child , Drug-Related Side Effects and Adverse Reactions , Female , Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 , Humans , Male , Middle Aged , Papillomavirus Infections , Pregnancy , Product Surveillance , Young Adult , Gardasil , Human papillomavirus , Safety , Surveillance , Vaccine