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

Key Points

Question

Does public sentiment of human papillomavirus (HPV) vaccine safety align with spontaneous HPV vaccine adverse event reporting data?

Findings

This cross-sectional analysis of the 2015 to 2018 National Immunization Survey indicates a 79.9% increase in the proportion of parents who refused the HPV vaccine for their adolescents due to safety concerns. In contrast, estimates from the national vaccine safety surveillance system found that the HPV vaccine adverse event reporting rate per 100 000 doses distributed decreased from 44.7 in 2015 to 29.4 in 2018.

Meaning

These findings suggest an urgent need to combat safety concerns about the HPV vaccine in the US.

Abstract

This cross-sectional study investigates trends in human papillomavirus (HPV) vaccine adverse event reporting and trends in HPV vaccine safety concerns among caregivers of vaccine-eligible US adolescents from 2015 to 2018.

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 39 364 unvaccinated adolescents with a mean (SD) age of 15.57 (0.08) years (26 996 White adolescents [62.9%], 22 707 male adolescents [56.1%], 11 392 privately insured [62.6%], and 32 674 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 170 046 to 259 157 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, 16 621 AE reports following HPV vaccination were reported to VAERS. The AE reporting rate per 100 000 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.