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.
JAMA Netw Open. 2021 Sep 1;4(9):e2124502. doi: 10.1001/jamanetworkopen.2021.24502.
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.
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.
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.
在美国，安全问题被认为是启动人乳头瘤病毒 (HPV) 疫苗的主要障碍。目前尚不清楚公众对 HPV 疫苗安全性的看法是否与上市后疫苗安全性监测数据一致。
平行评估 HPV 疫苗安全性担忧的趋势和 HPV 疫苗不良事件 (AE) 报告。
设计、地点和参与者：这是一项对国家免疫调查 (NIS) 和疫苗不良事件报告系统 (VAERS) 的横断面分析。NIS 的参与者为 13 至 17 岁的青少年。AE 由患者、医疗保健临床医生或其他来源向 VAERS 报告。统计分析于 2020 年 10 月至 2021 年 5 月进行。
2015 年至 2018 年 HPV 疫苗安全性担忧和 HPV 疫苗接种自发 AE 报告的季节性趋势。
39364 名未接种 HPV 疫苗的青少年的照顾者报告了他们未接种 HPV 疫苗系列的原因，这些青少年的平均 (SD) 年龄为 15.57(0.08)岁(26996 名白人青少年[62.9%]、22707 名男性青少年[56.1%]、11392 名私人保险[62.6%]和 32674 名贫困线以上[79.3%])。在 2015 年至 2018 年期间，将安全性问题作为不启动 HPV 疫苗系列的主要原因的比例从 13.0%(95%CI，12.1%-14.0%)增加到 23.4%(95%CI，21.8%-25.0%)(趋势 P<.001)，这相当于美国有 170046 至 259157 名青少年因安全性问题而不接种疫苗。30 个州的父母因安全性问题将其列为 HPV 疫苗犹豫的主要原因的比例有所增加。增幅最大(超过 200%)的是加利福尼亚州、夏威夷州、南达科他州和密西西比州。在 2015 年至 2018 年期间，VAERS 报告了 16621 例 HPV 疫苗接种后的 AE 报告。每 10 万剂分发的 AE 报告率从 2015 年的 44.7 降至 2018 年的 29.4(趋势 P<.001)。严重 AE 报告率，包括导致住院、残疾、危及生命的情况或死亡的报告率没有变化。
在这项描述性横断面研究中，HPV 疫苗犹豫的父母中观察到安全问题的比例上升，与非严重和严重 AE 报告趋势相反。这些发现表明迫切需要解决护理人员对安全问题日益增长的担忧，以增强 HPV 疫苗的信心。
