Abstract
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. To perform a parallel assessment of trends in HPV vaccine safety concerns and HPV vaccine adverse event (AE) reporting. 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. Secular trends in HPV vaccine safety concerns and spontaneous AE reporting for HPV vaccination from 2015 to 2018. 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. 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.
Highlights
The human papillomavirus (HPV) vaccine is effective for the prevention of up to 6 cancers.[1,2,3,4] Despite being licensed for over a decade, the HPV vaccine coverage remains suboptimal in the US, with 46% of vaccine-eligible adolescents not up-todate in 2019.5 the coverage varied substantially across states.[5]
Citing safety concerns as the primary reason for not initiating the HPV vaccine series increased from 13.0% in 2015 to 23.4% 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
Summary
The human papillomavirus (HPV) vaccine is effective for the prevention of up to 6 cancers (cervical, anal, oropharyngeal, penile, vaginal, and vulvar).[1,2,3,4] Despite being licensed for over a decade, the HPV vaccine coverage remains suboptimal in the US, with 46% of vaccine-eligible adolescents not up-todate in 2019.5 the coverage varied substantially across states (from nearly 80% in Rhode Island to only 30% in Mississippi).[5]. The HPV vaccine was demonstrated to be safe and effective in trials before its licensure.[1,4] Subsequent analyses of the Vaccine Adverse Drug Event Reporting System (VAERS) established postlicensure safety of the vaccine.[7,8,9] exposure to vaccine misinformation through traditional and social media has created a negative perception of HPV vaccine safety in public.[10,11] According to a recent national study, safety concern was the top reason for parental lack of willingness for initiating HPV vaccination.[12] The unfavorable views regarding HPV vaccine safety are contributing to lack in vaccine confidence at an individual level. Legislative bills proposing the HPV vaccine mandate were overturned, citing vaccine safety concerns.[13] Despite these repercussions, data documenting HPV vaccine safety perceptions, nationally and across the 50 states, is currently unavailable. Understanding the trends in reasons for failure to HPV vaccinate can provide insights into the extent to which safety-related concerns prevent individuals from receiving the HPV vaccine, and inform the development of interventions to ameliorate this barrier to vaccination
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