Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States

Abstract

Importance: In the US, safety concern has been identified as a primary barrier to initiating the human papillomavirus (HPV) vaccine. It is unclear if the public's sentiment concerning HPV vaccine safety aligns with postmarketing vaccine safety surveillance data. Objective: To perform a parallel assessment of trends in HPV vaccine safety concerns and HPV vaccine adverse event (AE) reporting. Design, Setting, and Participants: This study was a cross-sectional analysis of the National Immunization Survey (NIS) and Vaccine Adverse Event Reporting System (VAERS). Participants in the NIS were adolescents aged 13 to 17 years. AEs were reported to VAERS by patients, health care clinicians, or other sources. Statistical analysis was performed from October 2020 to May 2021. Main Outcomes and Measures: Secular trends in HPV vaccine safety concerns and spontaneous AE reporting for HPV vaccination from 2015 to 2018. Results: Caregivers of 39364 unvaccinated adolescents with a mean (SD) age of 15.57 (0.08) years (26996 White adolescents [62.9%], 22707 male adolescents [56.1%], 11392 privately insured [62.6%], and 32674 above the poverty level [79.3%]) reported their reasons for not initiating the HPV vaccine series in the 2015-2018 NIS. Citing safety concerns as the primary reason for not initiating the HPV vaccine series increased from 13.0% (95% CI, 12.1%-14.0%) in 2015 to 23.4% (95% CI, 21.8%-25.0%) in 2018 (P for trend