Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States.
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 < .001), equating to a change from 170046 to 259157 US adolescents not initiating the vaccine because of safety concerns. The proportion of parents citing safety concerns as the main reason for HPV vaccine hesitancy increased in 30 states. The largest increases (more than 200%) were observed in California, Hawaii, South Dakota, and Mississippi. During 2015 to 2018, 16621 AE reports following HPV vaccination were reported to VAERS. The AE reporting rate per 100000 doses distributed decreased from 44.7 in 2015 to 29.4 in 2018 (P for trend < .001). The serious AE reporting rate, including those leading to hospitalizations, disability, life-threatening condition, or death did not change.
Conclusions and Relevance: In this descriptive cross-sectional study, a rise in citing safety concerns was observed among parents with HPV vaccine hesitancy, contrary to the nonserious and serious AE reporting trends. These findings suggest an urgent need to combat the rising sentiment of safety concerns among caregivers to increase HPV vaccine confidence.
|投稿者||Sonawane, Kalyani; Lin, Yueh-Yun; Damgacioglu, Haluk; Zhu, Yenan; Fernandez, Maria E; Montealegre, Jane R; Cazaban, Cecilia Ganduglia; Li, Ruosha; Lairson, David R; Lin, Ying; Giuliano, Anna R; Deshmukh, Ashish A|
|ジャーナル名||JAMA network open|
|組織名||Center for Healthcare Data, Department of Management, Policy, and Community;Health, UTHealth School of Public Health, Houston, Texas.;Center for Health Services Research, Department of Management, Policy, and;Community Health, UTHealth School of Public Health, Houston, Texas.;Center for Health Promotion and Prevention Research, UTHealth School of Public;Health, Houston, Texas.;Department of Pediatrics, Baylor College of Medicine, Houston, Texas.;Department of Biostatistics and Data Science, School of Public Health, UT Health;Science Center at Houston, Houston, Texas.;Department of Industrial Engineering, University of Houston, Houston, Texas.;Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center,;Tampa, Florida.|