Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States.
Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States.
复制标题
美国人乳头瘤病毒疫苗安全问题和不良事件报告的趋势。
DOI：
10.1001/jamanetworkopen.2021.24502
复制
发表时间：
2021-09-01
影响因子：
13.8
通讯作者：
Deshmukh AA
中科院分区：
文献类型：
--
作者：
Sonawane K;Lin YY;Damgacioglu H;Zhu Y;Fernandez ME;Montealegre JR;Cazaban CG;Li R;Lairson DR;Lin Y;Giuliano AR;Deshmukh AA
公众对人乳头瘤病毒（HPV）疫苗安全性的看法与自发性HPV疫苗不良事件报告数据一致吗？对2015年至2018年全国免疫调查的横断面分析表明，出于安全考虑，拒绝为青少年接种HPV疫苗的父母比例增加了79.9%。相比之下，国家疫苗安全监测系统的估计发现，每10万剂分发的HPV疫苗不良事件报告率从2015年的44.7下降到2018年的29.4。这些发现表明，美国迫切需要消除对HPV疫苗的安全担忧。本横断面研究调查了2015年至2018年美国符合疫苗条件的青少年护理人员中人乳头瘤病毒（HPV）疫苗不良事件报告的趋势和HPV疫苗安全问题的趋势。在美国，安全性问题已被确定为启动人乳头瘤病毒（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监测数据相符。对HPV疫苗安全问题和HPV疫苗不良事件（AE）报告的趋势进行平行评估。本研究是对国家免疫调查（NIS）和疫苗不良事件报告系统（VAERS）的横断面分析。NIS的参与者是13至17岁的青少年。ae由患者、卫生保健临床医生或其他来源报告给VAERS。统计分析时间为2020年10月至2021年5月。2015年至2018年HPV疫苗安全问题的长期趋势和HPV疫苗接种的自发性AE报告39 364名未接种疫苗的青少年（平均（SD）年龄为15.57（0.08）岁）（26 996名白人青少年[62.9%]，22 707名男性青少年[56.1%]，11 392名私人保险青少年[62.6%]，32 674名贫困以上青少年[79.3%]）的照顾者报告了他们在2015-2018年NIS中未接种HPV疫苗系列的原因。将安全问题作为不启动HPV疫苗系列的主要原因从2015年的13.0% （95% CI, 12.1%-14.0%）增加到2018年的23.4% (95% CI, 21.8%-25.0%) （P为趋势<）。001)，相当于由于安全考虑而不接种疫苗的美国青少年从170 046人变为259 157人。在30个州，将安全问题作为HPV疫苗犹豫的主要原因的父母比例有所增加。增幅最大的是加州、夏威夷、南达科他州和密西西比州，增幅超过200%。2015年至2018年期间，向VAERS报告了16 621例HPV疫苗接种后的AE报告。AE报告率从2015年的每10万剂44.7下降到2018年的29.4（趋势P < 0.001）。严重AE的报告率，包括导致住院、残疾、危及生命的情况或死亡的发生率没有变化。在这一描述性横断面研究中，在HPV疫苗犹豫的父母中发现了安全问题的增加，这与不严重和严重的AE报告趋势相反。这些发现表明，迫切需要对抗护理人员日益增长的安全担忧情绪，以增加HPV疫苗的信心。
Does public sentiment of human papillomavirus (HPV) vaccine safety align with spontaneous HPV vaccine adverse event reporting data? 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. These findings suggest an urgent need to combat safety concerns about the HPV vaccine in the US. 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. 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.
登录
查看更多内容
DOI：
10.1056/nejmoa0909537
发表时间：
2011-02-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Giuliano AR;Palefsky JM;Goldstone S;Moreira ED Jr;Penny ME;Aranda C;Vardas E;Moi H;Jessen H;Hillman R;Chang YH;Ferris D;Rouleau D;Bryan J;Marshall JB;Vuocolo S;Barr E;Radley D;Haupt RM;Guris D
通讯作者：
Guris D
影响因子：
5.5
作者：
Freed, GL;Clark, SJ;Santoli, JM
通讯作者：
Santoli, JM
影响因子：
4.8
作者：
Lama, Yuki;Quinn, Sandra Crouse;Cruz-Cano, Raul
通讯作者：
Cruz-Cano, Raul
影响因子：
5.5
作者：
Liddon, Nicole C.;Hood, Julia E.;Leichliter, Jami S.
通讯作者：
Leichliter, Jami S.
影响因子：
3.1
作者：
Cummings, Teresa;Kasting, Monica L.;Stupiansky, Nathan W.
通讯作者：
Stupiansky, Nathan W.