Zhu Z K, Lu X, Tang W Q, Sun J W, Shen L, Chen Q L, Liu H X, Yu Y, Gu W, Zhao Y W, Xie Y
Taizhou Center for Disease Control and Prevention, Taizhou 225300, China.
Sinovac Biotech Co., Ltd., Beijing 100085, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Sep 6;57(9):1412-1417. doi: 10.3760/cma.j.cn112150-20230417-00295.
To evaluate the safety of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older. From November 2021 to May 2022, eligible participants aged 60 years and older were recruited in Taizhou City, Jiangsu Province, China, and a total of 2 461 participants were ultimately enrolled in this study. Each participant simultaneously received one dose of quadrivalent influenza split virion vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine. The safety was observed within 28 days after vaccination. Safety information was collected through voluntary reporting and regular follow-ups. All 2 461 participants completed the simultaneous administration of both vaccines and the safety follow-ups for 28 days after vaccination. The mean age of the participants was (70.66±6.18) years, with 54.61% (1 344) being male, and all participants were Han Chinese residents. About 22.51% (554) of the participants had underlying medical conditions. The overall incidence of adverse reactions within 0-28 days after simultaneous vaccination was 2.07% (51/2 461), mainly consisting of Grade 1 adverse reactions [1.83% (45/2 461)], with no reports of Grade 4 or higher adverse reactions or vaccine-related serious adverse events. The incidence of local adverse reactions was 0.98% (24/2 461), primarily presenting as pain at the injection site [0.93% (23/2 461)]. The incidence of systemic adverse reactions was 1.42% (35/2 461), with fever [0.85% (21/2 461)] being the main symptom. In the group with underlying medical conditions and the healthy group, their overall incidence of adverse reactions was 2.53% (14/554) and 1.94% (37/1 907), respectively. The incidence of local adverse reactions in the two groups was 1.62% (9/554) and 0.79% (15/1 907), respectively, and the incidence of systemic adverse reactions was 1.44% (8/554) and 1.42% (27/1 907), respectively, with no statistically significant differences between them (all >0.05). It is safe for adults aged 60 years and older to receive quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine at the same time.
评估60岁及以上成年人同时接种四价流感裂解病毒疫苗和23价肺炎球菌多糖疫苗的安全性。2021年11月至2022年5月，在中国江苏省泰州市招募了符合条件的60岁及以上参与者，最终共有2461名参与者纳入本研究。每位参与者同时接种一剂四价流感裂解病毒疫苗和一剂23价肺炎球菌多糖疫苗。在接种疫苗后28天内观察安全性。通过自愿报告和定期随访收集安全信息。所有2461名参与者均完成了两种疫苗的同时接种及接种后28天的安全性随访。参与者的平均年龄为（70.66±6.18）岁，男性占54.61%（1344名），所有参与者均为汉族居民。约22.51%（554名）的参与者有基础疾病。同时接种疫苗后0至28天内不良反应的总体发生率为2.07%（51/2461），主要为1级不良反应[1.83%（45/2461）]，无4级及以上不良反应或疫苗相关严重不良事件报告。局部不良反应发生率为0.98%（24/2461），主要表现为注射部位疼痛[0.93%（23/2461）]。全身不良反应发生率为1.42%（35/2461），主要症状为发热[0.85%（21/2461）]。有基础疾病组和健康组的不良反应总体发生率分别为2.53%（14/554）和1.94%（37/1907）。两组局部不良反应发生率分别为1.62%（9/554）和0.79%（15/1907），全身不良反应发生率分别为1.44%（8/554）和1.42%（27/1907），差异均无统计学意义（均>0.05）。60岁及以上成年人同时接种四价流感裂解病毒疫苗和23价肺炎球菌多糖疫苗是安全的。
