Studies Find Cancer-preventing HPV Vaccine Gardasil®Safe

​Human papillomavirus (HPV) is extremely common, with 14 million new infections every year in the U.S., and while most infections do not cause any symptoms, some can progress to cancer later in life. Each year in the United States, there are approximately 34,800 cancers caused by HPV, including 20,700 in women and 14,100 in men, which is why pediatricians recommend all young people get the HPV vaccine. In a new study, "Safety of the 9-Valent Human Papillomavirus Vaccine," in the December 2019 Pediatrics (online Nov. 18), investigators analyzed data from CDC's Vaccine Adverse Event Reporting System (VAERS) and did not identify any new or unexpected safety problems for the 9-valent human papillomavirus vaccine (Gardasil®9). Investigators reviewed reports to VAERS of Gardasil®9, which was licensed by the FDA in December 2014, during a three-year period when approximately 28 million vaccine doses were distributed in the U.S. VAERS received 7,244 reports, of which 97.4% were classified as non-serious: headache, dizziness, fainting, and irritation at the injection site. The authors conclude that healthcare providers, parents, and patients should be reassured about the safety of Gardasil®9. These data add to the body of evidence that supports the safety of the vaccine, which also includes the pre-licensure clinical trial involving 15,000 study subjects and another large epidemiologic study of approximately 839,000 doses of the vaccine (also in this issue of Pediatrics).

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit www.aap.org and follow us on Twitter @AmerAcadPeds