Pediatr Infect Dis J. 2015 Jun 22.
Abstract
Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD(R)) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and pre-cancers, 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, 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 8 years since licensure, including more than 15 studies in more than one million pre-adolescents, adolescents, and adults from various countries. Most have been performed in the general population though there have been some in special populations (pregnant women, human immunodeficiency virus infected individuals, and those with Systemic Lupus Erythematosus).
Results: We present a summary of the published, post-licensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the post-licensure 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 pre-licensure 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.