3岁及以上人群新型冠状病毒灭活疫苗接种反应临床观察分析

目的 评价贵州省≥3岁人群接种新型冠状病毒（新冠病毒）灭活疫苗的安全性。方法 采用开放式设计，于2021年6月至2022年7月在贵州省沿河县招募符合条件的人群，按照（0，28）d免疫程序接种2剂次新冠病毒灭活疫苗，收集每剂次疫苗接种后30 min内和0~28 d的不良反应，分年龄、剂次、患病情况分析不良反应发生率。结果 总不良反应发生率为1.51%（294/19 458），所有不良反应均发生在接种后7 d内，严重程度为1级或2级，以接种部位疼痛最常见。3~、18~和≥60岁组不良反应发生率分别为1.01%（58/5 721）、2.44%（220/9 017）和0.34%（16/4 720），差异有统计学意义（P<0.001）。第1剂次接种后不良反应发生率（1.20%，233/19 458）高于第2剂次（0.37%，61/16 368），差异有统计学意义（P<0.001）。≥60岁组中健康人群和患基础疾病人群不良反应发生率分别为0.36%（9/2 520）和0.32%（7/2 200），差异无统计学意义（P=0.818）。结论 ≥3岁人群接种新冠病毒灭活疫苗安全性良好，在老年健康人群和患基础疾病人群中接种均具有良好安全性。     

不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种的安全性观察

目的 评价使用不同毒株脊髓灰质炎灭活疫苗（IPV）开展序贯免疫程序在大规模人群中使用的安全性。方法 于2017年3月至2018年5月,采用随机、平行对照设计,以Sabin株脊髓灰质炎灭活疫苗（sIPV）、野毒株脊髓灰质炎灭活疫苗（wIPV）和Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗（bOPV）作为研究疫苗,在上海市选择1 917例2月龄婴儿为研究对象,分为4组：①sIPV+sIPV+bOPV;②sIPV+wIPV+bOPV;③wIPV+sIPV+bOPV;④wIPV+wIPV+bOPV,采用主动观察的方法观察其在2、3、4月龄接种后的不良反应。结果 4组完成3剂基础免疫接种后总的不良事件发生率为16.79%（946/5 633）,各组均未报告严重不良事件,全身和局部反应均以轻度反应为主。常见局部反应为注射部位疼痛、红和硬结等;全身反应为异常哭闹、嗜睡、腹泻和食欲下降等。接种后30 d内,局部反应率为1.65%（93/5 633）,其中轻度、中度和重度反应率分别为1.26%（71/5 633）、0.21%（12/5 633）和0.20%（11/5 633）;全身反应率为15.14%（853/5 633）,其中轻度、中度和重度反应率分别为11.33%（638/5 633）、3.18%（179/5 633）和0.64%（36/5 633）。各组间重度反应率差异无统计学意义（χ²=4.17,P=0.24）。结论 本研究中未观察到使用不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种相关的严重不良事件,多数为轻度的不良反应,所有反应均痊愈。同时或交替使用sIPV和wIPV开展序贯免疫程序对于适龄儿童均具有良好的预防接种安全性。     

中国狂犬病疫苗不良反应发生率Meta分析

目的 对中国地区狂犬病暴露后的普通人群全程接种狂犬病疫苗后不良反应发生率进行Meta分析,为开展狂犬病疫苗接种策略改进提供数据支持。方法 计算机检索中国知网、万方数据知识服务平台、维普期刊资源整合服务平台、中国生物医学文献服务系统、PubMed英文数据库和The Cochrane Library中公开发表的有关狂犬病疫苗接种后不良反应的研究文献,检索时限为2000年1月至2016年7月,根据纳入和排除标准收集资料,采用R软件对狂犬病疫苗不良反应发生率进行Meta分析。结果 共纳入29篇文献,纳入文献无明显发表偏倚,其中总调查人数为94 222人,发生不良反应11 020例,不良反应发生率为1.04%～47.78%。狂犬病疫苗总不良反应的合并发生率为9.82%（95% CI：7.58%～12.72%）,局部不良反应的合并发生率为12.05%（95% CI：9.26%～15.69%）,全身不良反应的合并发生率为9.06%（95% CI：7.07%～11.61%）。液体疫苗接种不良反应合并率为32.39%（95% CI：21.88%～47.94%）,冻干疫苗接种不良反应合并率为8.65%（95% CI：4.54%～16.51%）,两组差异有统计学意义（P<0.05）。结论 狂犬病疫苗接种局部不良反应率高于全身不良反应率。液体狂犬病疫苗不良反应率高于冻干狂犬病疫苗,建议采用安全性较好的冻干狂犬病疫苗,逐步替代液体狂犬病疫苗。     

新型冠状病毒灭活疫苗不同接种间隔的免疫原性和安全性研究

目的 比较公安人员按不同方案（0~14 d、0~21 d、0~28 d）接种新型冠状病毒（新冠病毒）灭活疫苗的免疫原性和安全性。方法 于2021年1-2月以山西省太原市405名公安人员为研究对象,通过随机分组将其分为3组,分别按照0~14 d、0~21 d和0~28 d方案接种2剂新冠病毒灭活疫苗,采用RT-PCR检测新冠病毒核酸,活病毒微量病变法检测新冠病毒中和抗体,分析3组的新冠病毒中和抗体GMT、血清阳转率和安全性。结果 0~14 d、0~21 d和0~28 d方案组新冠病毒中和抗体血清学阳转率均为100%,其中0~21 d组[166.70（95%CI：148.30~185.10）]和0~28 d组[179.50（95%CI：156.50~202.60）]新冠病毒中和抗体水平接近（P>0.05）,均明显高于0~14 d组[86.08（95%CI：72.36~99.80）]（P<0.001）。3个方案组不良反应发生率分别为1.48%（2/135）、0.74%（1/136）和1.49%（2/134）（P=0.750）,均为轻度不良反应。结论 公安人员按不同方案（0~14 d、0~21 d、0~28 d）接种新冠病毒灭活疫苗后均表现出较好的血清阳转率和安全性,0~21 d和0~28 d接种方案组新冠病毒中和抗体GMT高于0~14 d方案组。     

合肥市新型冠状病毒灭活疫苗(Vero细胞)紧急接种期间安全性

  目的  探讨合肥市新型冠状病毒灭活疫苗(Vero细胞)(简称新冠疫苗)在紧急接种期间的安全性,为该疫苗后期在全人群中的推广接种提供参考。  方法  在合肥市抽取19家预防接种门诊作为免疫安全性主动监测点,于2020年12月15日-2021年2月10日对合肥市接种新冠疫苗的18~59岁重点人群进行观察,对疫苗接种后不良反应发生率、不良反应类型及严重程度进行描述性分析。  结果  有效观察18 574人,累积接种新冠疫苗33 433剂次,接种发生一般不良反应713例次,发生率2.13%,第1剂次不良反应发生率为2.57%,高于第2剂次不良反应发生率1.58%(χ2=38.92, P < 0.001),2家公司生产灭活疫苗一般反应发生率的差异无统计学意义(χ2=3.08, P=0.082);在注射部位红肿、注射部位硬结、发热等不良事件中,1、2和3级不良事件发生率分别为0.65%、1.42%和0.06%,未发现≥4级及罕见和极罕见不良事件。  结论  国产新型冠状病毒灭活疫苗(Vero细胞)具有较高的安全性。     

戊型肝炎疫苗和乙型肝炎疫苗联合接种的安全性及免疫原性研究

目的 分析戊型肝炎（戊肝）疫苗和乙型肝炎（乙肝）疫苗联合接种（联合接种）的安全性及免疫原性。方法 2015年9月至2016年12月在北京市朝阳区招募18~60岁健康受试者720人,将符合纳入标准的受试者随机化分为3组：联合接种（联合接种）组、乙肝疫苗接种组和戊肝疫苗接种组。3组均按照0、1、6个月程序接种,比较联合接种与单独接种的安全性及全程免疫1个月后的免疫原性。结果 接种疫苗的受试者共601人（戊肝疫苗接种组150人,乙肝疫苗接种组159人,联合接种组292人）。联合接种组的局部不良反应有疼痛（25.0%,73/292）、红（12.7%,37/292）、瘙痒（9.2%,27/292）、硬结（8.9%,26/292）、肿（8.2%,24/292）,全身不良反应有发热（7.2%,21/292）、头痛（5.8%,17/292）、肌肉痛（5.5%,16/292）、疲倦乏力（3.4%,10/292）。联合接种组除局部疼痛发生率高于单独接种组以外,其余不良反应与单独接种组均无明显差异,3组均无严重不良反应。全程接种1个月后,联合接种组的HBsAb阳转率、抗体几何平均浓度（GMC）非劣效于乙肝疫苗接种组（94.2%比93.8%,611.6 WU/ml比745.1 WU/ml）,HEV IgG抗体阳转率、GMC非劣效于戊肝疫苗接种组（98.8%比100.0%,11.0 WU/ml比18.0 WU/ml）。结论 联合接种具有良好的安全性和免疫原性,建议肝炎易感人群联合接种戊、乙肝疫苗,更好地保护肝脏。     

宁波市新型冠状病毒肺炎密切接触者感染流行病学特征分析

目的 估算新型冠状病毒肺炎病例密切接触者的感染率,评估不同暴露状况下新型冠状病毒肺炎的发病风险。方法 采用前瞻性研究的方法,对新型冠状病毒肺炎病例和无症状感染者的密切接触者进行持续隔离医学观察,收集流行病学、临床表现和实验室检测资料,估算不同暴露下的密切接触者感染率。结果 宁波市新型冠状病毒肺炎发病流行曲线呈现持续的人传人特征。共追踪调查了2 147名密切接触者,总感染率为6.15%,确诊病例、无症状感染者的密切接触者感染率分别为6.30%和4.11%,差异无统计学意义（P>0.05）。不同关系的密切接触者中,以朋友/香客（22.31%）、家庭成员（18.01%）、亲戚（4.73%）感染较高率,医务人员密切接触者未发生感染,各密切接触者人群感染率差异有统计学意义（P<0.005）。与病例同住（13.26%）、乘坐同一个交通工具（11.91%）、聚餐娱乐（7.18%）均是感染高危因素。医院诊疗环境下的交叉感染也不容忽视（1.94%）。潜伏期中位数为5 d。结论 新型冠状病毒肺炎病例密切接触者的感染率高,需严格按照密切接触者管理方案实施隔离医学观察措施。     

四价流感病毒灭活疫苗在18~64岁人群免疫原性和安全性的系统综述和Meta分析

目的 用Meta分析的方法评价四价流感病毒灭活疫苗在18~64岁人群的免疫原性（抗体保护率和抗体阳转率）。方法 检索Medline、Cochrane Library、Science Direct数据库,将近10年内发表的比较18~64岁人群接种四价流感病毒灭活疫苗和三价流感病毒灭活疫苗免疫原性的临床随机对照试验纳入分析。采用Revman 5.3软件对纳入文献数据进行Meta分析。结果 共纳入8篇文献,针对甲型流感株（A/H1N1、A/H3N2）的抗体保护率和抗体阳转率,两种疫苗的反应差异无统计学意义;针对不含乙型流感株B/Victoria的三价流感病毒灭活疫苗,四价流感病毒灭活疫苗抗体保护率的合并RR值为1.28（95% CI：1.08~1.51,P<0.05）,抗体阳转率的合并RR值为1.94（95% CI：1.50~2.50,P<0.05）;针对不含乙型流感株B/Yamagata的三价流感病毒灭活疫苗,四价流感病毒疫苗抗体保护率的合并RR值为1.10（95% CI：1.02~1.18,P<0.05）,抗体阳转率的合并RR值为1.99（95% CI：1.34~2.97,P<0.05）,差异有统计学意义。结论 18~64岁人群中,四价流感病毒灭活疫苗与三价流感病毒灭活疫苗对于相同的疫苗株产生的免疫原性无差异,对于三价流感病毒灭活疫苗中不含的乙型疫苗株能产生良好的免疫效果。     

3~11岁儿童接种新型冠状病毒灭活疫苗的免疫原性研究

目的 评价3~11岁儿童完成新型冠状病毒（新冠病毒）疫苗基础免疫28~42 d后对原始株的免疫原性及与新冠病毒变异株的交叉免疫反应。方法 于2022年1-7月在山东省乳山市招募3~11岁已按照（0,28）d免疫程序完成2剂新冠病毒灭活疫苗基础免疫的受试者,基础免疫后28~42 d采集静脉血3 ml,检测原始株、Beta、Gamma和Delta变异株的中和抗体水平,计算中和抗体阳性率和GMT。结果 纳入免疫原性分析共395人,其中3~5岁组212人,6~11岁组183人。受试者完成基础免疫后28~42 d,血清中对原始株、Beta、Gamma和Delta变异株的中和抗体阳性率分别为100.00%、74.68%、99.24%和97.22%,年龄组间差异无统计学意义（P>0.05）。受试者完成基础疫苗后28~42 d,血清中对原始株、Beta、Gamma和Delta变异株的中和抗体GMT分别为168.19、10.51、53.65和31.10,年龄组间差异无统计学意义（P>0.05）。结论 在3~11岁儿童中接种2剂新冠病毒灭活疫苗的免疫原性良好,可对新冠病毒变异株产生一定的交叉保护。     

构建大规模人群新型冠状病毒核酸筛查指标体系研究

目的 建立适用于大规模人群新型冠状病毒（新冠病毒）核酸筛查时,科学确定筛查范围的指标体系。方法 采用文献检索和头脑风暴法,拟定大规模人群新冠病毒核酸筛查指标体系初始框架和指标,通过层次分析法及Delphi法结合的方式,对全国21名专家进行两轮咨询,确定大规模人群新冠病毒核酸筛查指标体系及权重。结果 两轮咨询的专家积极指数均为100%,权威系数（Cr）分别为0.88±0.08、0.89±0.07,变异系数（CV）范围（0.08,0.24）、（0.09,0.25）;Kendall''s W协调系数分别为0.34、0.22,差异有统计学意义（χ²=97.02、249.90,P<0.05）。最终确立了包括4个一级指标、11个二级指标、58个三级指标的大规模人群新冠病毒核酸筛查指标体系,并确定了各指标权重。结论 初步建立了大规模人群新冠病毒核酸筛查指标体系,对卫生行政部门科学和精准地确定大规模人群筛查范围时提供参考依据。     

HIV感染者新型冠状病毒疫苗序贯加强免疫1例并文献复习

 人类免疫缺陷病毒(HIV)感染者存在不同程度的免疫缺陷,可能导致新型冠状病毒疫苗接种的有效性低于正常人群。HIV感染者应是新型冠状病毒疫苗加强针的优先群体,然而目前国内外尚未检索到HIV感染者接种新型冠状病毒灭活疫苗后使用腺病毒载体疫苗序贯加强免疫的报道。故本文报告1例HIV感染者,通过抗逆转录病毒治疗(ART)后,HIV得到良好抑制,CD4⁺T细胞计数正常,接种两剂新型冠状病毒灭活疫苗(国药集团中国生物北京生物制品研究所有限责任公司)后使用腺病毒载体疫苗(康希诺生物股份公司)序贯加强免疫,安全且具有高度免疫原性,为指导该人群新型冠状病毒疫苗接种提供参考依据。     

上海市浦东新区18岁及以上人群接种新型冠状病毒灭活疫苗疑似预防接种异常反应监测结果分析

目的 评价上海市浦东新区18岁及以上人群接种新型冠状病毒灭活疫苗（简称新冠灭活疫苗）的安全性,为人群接种提供科学依据。方法 收集中国疾病预防控制信息系统中2020年12月—2021年6月浦东新区新冠灭活疫苗疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测数据进行统计分析。结果 浦东新区共报告新冠灭活疫苗AEFI病例2430例,其中一般反应1240例（51.03%）、异常反应260例（10.70%）、心因性反应699例（28.76%）、偶合症231例（9.51%）,不良反应报告发生率为20.63 /10万剂次,其中一般反应和异常反应报告发生率分别为17.06 /10万剂次和3.58/10万剂次。女性不良反应报告发生率（27.71/10万剂次）高于男性（14.72/10万剂次）,第1剂次（28.08/10万剂次）高于第2剂次（12.12/10万剂次）。结论 浦东新区接种的新冠灭活疫苗在安全性范围内。     

Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021–June 30, 2022

BackgroundCOVID-19 vaccines may be co-administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.ObjectiveTo describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of mRNA COVID-19 and seasonal influenza vaccines.MethodsWe searched the VAERS database for reports of adverse events (AEs) following co-administration of mRNA COVID-19 and seasonal influenza vaccines and following a first booster dose mRNA COVID-19 vaccine alone, during July 1, 2021–June 30, 2022. We assessed the characteristics of these reports and described the most frequently reported MedDRA preferred terms (PTs). Clinicians reviewed available medical records for serious reports and reports of adverse events of special interest (AESI) and categorized the main diagnosis by system organ class.ResultsFrom July 1, 2021 through June 30, 2022, VAERS received 2,449 reports of adverse events following co-administration of mRNA COVID-19 and seasonal influenza vaccines. Median age of vaccinees was 48 years (IQR: 31, 66); 387 (15.8%) were classified as serious. Most reports (1,713; 69.3%) described co-administration of a first booster dose of an mRNA COVID-19 vaccine with seasonal influenza vaccine. The most common AEs among non-serious reports were injection site reactions (193; 14.5%), headache (181; 13.6%), and pain (171; 12.8%). The most common AEs among reports classified as serious were dyspnea (38; 14.9%), COVID-19 infection (32; 12.6%), and chest pain (27; 10.6%).DiscussionThis review of reports to VAERS following co-administration of mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19 disease) was expected. CDC will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines, including co-administration involving bivalent mRNA COVID-19 booster vaccines that have been recommended for people ages ≥ 6 months in the United States.     

A phase III,observer-blind,randomized, placebo-controlled study of the efficacy,safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: An interim analysis in Indonesia

BackgroundThe WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine.MethodsWe conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18–59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose.ResultsMost of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%.ConclusionsFrom the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.     

狂犬病疫苗接种者的免疫效果分析

[目的]了解狂犬病暴露者接种狂犬病疫苗后的免疫效果,探讨预防策略。[方法]观察疫苗使用者的反应情况,随机抽取624例狂犬病暴露者接种狂犬病疫苗5针(0、3、7、14、28d)后10～20d采集静脉血,采用间接酶联免疫吸附试验(ELISA)测定狂犬病毒(RV)IgG抗体。[结果]报告接种反应发生率为9.35/万,无严重不良反应;624例暴露者接种疫苗后RV-IgG抗体阳性594人,平均阳性率95.19%;男、女暴露者RV-IgG抗体阳性率差异无统计学意义(χ2=0.719,P﹥0.05);﹤15岁人群抗体阳性率最高100%,﹥65岁率最低为90.48%,随年龄增大抗体阳性率呈下降趋势,各年龄组间抗体阳性率差异有统计学意义(χ2=19.146,P﹤0.01);大连金港安迪、辽宁依生、辽宁成大、宁波荣安、武汉5家生物所的疫苗抗体阳性率之间差异无统计学意义(χ2=8.638,P﹥0.01),但均高于长春生物所χ2=95.446,P﹤0.01);大连金港安迪、辽宁成大、宁波荣安3所各批号疫苗抗体阳性率差异无统计学意义(χ2=1.02、1.26、0.22,P均﹥0.05)。[结论]国产狂犬病疫苗免疫效果好;年龄小者免疫效果优于年长者;除个别外多数厂家疫苗免疫效果差异不大;暴露后使用国产疫苗能够起到预防狂犬病作用。     

Acute reactions after a homologous primary COVID-19 vaccination series: Analysis of Taiwan V-Watch data

IntroductionThe ChAdOx1 nCoV-19 (ChAd), mRNA-1273 (m1273), MVC-COV1901 (MVC), and BNT162b2 (BNT) COVID-19 vaccines received authorization for emergency use in Taiwan beginning in February 2021. We investigated acute reactions to homologous primary COVID-19 vaccination series in adults aged ≥ 18 years.MethodsIn this prospective observational study based on smartphone data (Taiwan V-Watch), we calculated the frequencies of self-reported local and systemic acute reactions within 7 days of a COVID-19 vaccination, and the health effects up to 3 weeks after each dose. Those who reported adverse reactions after both doses were assessed by the McNemar test.ResultsDuring 22 March 2021–13 December 2021, 77,468 adults were enrolled; 59.0 % were female and 77.8 % were aged 18–49 years. For both doses of all four vaccines, the local and systemic reactions were minor in severity and highest on days 1 and 2 after vaccination, and declined markedly until day 7. For 65,367 participants who provided data after the first and second doses, systemic reactions were more frequent after dose 2 of the BNT and m1273 vaccines (McNemar tests: both p < 0.001), while local reactions were more frequent after dose 2 of the m1273 and MVC vaccines (both p < 0.001), compared with dose 1 of the homologous vaccine. Among the participants aged 18–49 years, the percentage who missed work on the day after vaccination was slightly higher among women (9.3 %) than among men (7.0 %).ConclusionsAcute reactogenicity and impact of work absenteeism for the four COVID vaccines in the V-Watch survey were mild and of short duration.     

Safety and adverse effects of the coronavirus disease 2019 vaccine among the general Japanese adult population

ObjectivesWe aimed to identify and explore the association between the characteristics of coronavirus disease 2019 (COVID-19) vaccine recipients and the types of vaccine-related adverse effects in the general Japanese adult population.MethodsAn anonymous self-report questionnaire was distributed to 4393 students and 1657 white and blue-collar workers (N = 6050). Data on vaccine-related adverse effects were collected twice, once after each vaccination. The data collection was performed daily from the day of injection (D0) until the sixth day after injection (D6). The list of adverse effects comprised local reactions at the injection site (pain, redness, and swelling) and systemic symptoms (fever, fatigue, headache, myalgia, joint pain, chills, and nausea or vomiting). The Student's t-test and Mann–Whitney U test were used to analyze parametric and non-parametric data, respectively.ResultsThe incidence of adverse reactions to the COVID-19 vaccination was higher after the second dose (e.g., redness: 47.1%; swelling: 60.6%; fever: 80.6%) of vaccination than after the first dose (e.g., redness: 16.4%; swelling: 37.2%; fever: 11.9%). Women reported adverse reactions to the vaccination more frequently. Some adverse reactions included more symptoms in younger participants, and participants with a lower body mass index were more at risk for these symptoms.ConclusionsSome adverse reactions to the COVID-19 vaccination are a greater risk of symptoms in the younger group, women, and participants with lower BMI. Care should be taken to monitor women, younger people, and individuals with a low body mass index for adverse effects after receiving the COVID-19 vaccination.     

Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (CoronaVac) co-administered with an inactivated quadrivalent influenza vaccine: A randomized,open-label,controlled study in healthy adults aged 18 to 59 years in China

BackgroundStudies are needed for evidence of inactivated COVID-19 vaccine co-administered with influenza vaccine.MethodsA randomized, open-label, controlled study was conducted in Zhejiang Province, China. Eligible healthy adults aged 18–59 years underwent randomization at a ratio of 1:1:2 to receive inactivated quadrivalent influenza vaccine (IIV4) either concomitantly with the first (C1 subgroup) or the second (C2 subgroup) dose of CoronaVac, or 14 days after the first dose of CoronaVac (S group). The primary purpose of the study was to prove the non-inferiority in seroconversion rate of antibody against SARS-CoV-2.ResultsOverall, 480 participants were enrolled, with 120, 120, and 240 randomly assigned to the C1, C2, and S groups, respectively. As lower bound of the two-sided 95% confidence interval (CI) of the difference for the seroconversion rate of antibodies against SARS-CoV-2 was over ?10%, the immune response for CoronaVac in the C group (93.1% [89.0, 96.0]) was non-inferior to that in the S group (95.2% [91.5, 97.6]) in the per-protocol set. A lower GMT of antibody against SARS-CoV-2 was observed in the C group as compared to the S group (27.5 vs. 38.1, P = 0.0001). Decrease of immune response to CoronaVac was mainly observed in participants received IIV4 concomitantly with their second dose of CoronaVac (C2 subgroup), with a seroconversion rate of 89.7% (95CI: 82.6%-94.5%) and a GMT of 23.3. The occurrences of vaccine related adverse reactions were no more than 20% and comparable among different groups. Most of the adverse reactions were mild and moderate.ConclusionCo-administration of inactivated COVID-19 vaccine and seasonal influenza vaccine, especially the administration regimen that the seasonal influenza vaccine co-administered with the first dose of the inactivated COVID-19 vaccine, would be feasible.     

Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review

ObjectivesEmergence of severe acute respiratory syndrome coronavirus 2 infections and the resultant disease, COVID-19 led the world into 238 million cases and 4.8 million deaths over the first 22 months of the pandemic. While numerous vaccines have been developed to combat this pandemic, limited literature is available regarding the comparison of these vaccines. This study aims to systematically review and evaluate the immunogenicity and safety of COVID-19 vaccines compared with control arms in the healthy adult population.MethodsA literature search was conducted in PubMed, MEDLINE, Embase, and Cochrane up to July 4, 2021. Randomized controlled trials assessing the immunogenicity of any dose of COVID-19 vaccine in adults by anti–severe acute respiratory syndrome coronavirus 2 immunoglobulin G antibodies geometric mean titers (GMTs) and neutralizing antibodies GMT response at 28 days postimmunization compared with the control groups in the healthy adults were considered for inclusion. Groups at day 28 with the highest GMT were further examined for their adverse events.ResultsOf the 341 citations retrieved, 19 were included. This covered a total of 16 vaccines involving 8342 subjects aged between 30.8 and 69.7 years, comprising 52.13% females. All studies reported GMT at or close to 28 days postvaccination compared with placebo and comparator, and 13 of 19 studies reported seroconversion rates. While 15 of 16 vaccines reported adverse events that ranged from mild to severe, 1 of 16 (AD26.COV2.S) noted 1 case of a vaccine-related serious adverse event—high fever 6 hours after vaccination. Local reactions (such as redness, pain, and swelling) and systematic reactions (such as fatigue, fever, and headache) were commonly noted. Safety between vaccines was similar; however, higher rates of severe adverse events were noted in Ad5-vectored COVID-19, AD26.COV2.S, ChAdOx nCoV-19, and mRNA-1273. No all-cause mortality was documented in any vaccines.ConclusionsAll 16 vaccines elicited an immune response substantially higher than the control groups while maintaining tolerable safety profiles.     

Effectiveness of adenovirus type 5 vectored and inactivated COVID-19 vaccines against symptomatic COVID-19, COVID-19 pneumonia,and severe COVID-19 caused by the B.1.617.2 (Delta) variant: Evidence from an outbreak in Yunnan,China, 2021

BackgroundIn partial response to the coronavirus disease 2019 (COVID-19) pandemic, countries around the world are conducting large-scale vaccination campaigns. Real-world estimates of vaccine effectiveness (VE) against the B.1.617.2 (Delta) variant are still limited. An outbreak in Ruili city of China provided an opportunity to evaluate VE against the Delta variant of two types of COVID-19 vaccines in use in China and globally – inactivated (CoronaVac and BBIBP-CorV) and adenovirus type 5 vectored (Convidecia) vaccines.MethodsWe estimated VE using a retrospective cohort study two months after the Ruili vaccination campaign (median: 63 days). Close contacts of infected people (Chinese nationality, 18 years and above) were included to assess VE against symptomatic Covid-19, COVID-19 pneumonia, and severe COVID-19. We calculated the relative risks (RR) of the outcomes for unvaccinated compared with fully vaccinated individuals. We used logistic regression analyses to estimate adjusted VEs, controlling for gender and age group (18–59 years and 60 years and over).We compared unvaccinated and fully vaccinated individuals on duration of RT-PCR positivity and Ct value.FindingsThere were 686 close contacts eligible for VE estimates. Adjusted VE of ad5-vectored vaccine was 61.5% (95% CI, 9.5–83.6) against symptomatic COVID-19, 67.9% (95%CI: 1.7–89.9) against pneumonia, and 100% (95%CI: 36.6–100) against severe/critical illness. For the two inactivated vaccines, combined VE was 74.6% (95% CI, 36.0–90.0) against symptomatic COVID-19, 76.7% (95% CI: 19.3–93.3) against pneumonia, and 100% (95% CI: 47.6–100) against severe/critical COVID-19. There were no statistically significant differences in VE between two inactivated vaccines for symptomatic COVID-19 and for pneumonia, nor were there statistically significant differences between inactivated and ad5-vectored VE in any of the three outcomes. The median durations of RT-PCR positivity were 17 days for fifteen people vaccinated with an inactivated vaccine, 18 days for forty-four people vaccinated with the Ad5 vectored vaccine, and 26 days for eleven unvaccinated individuals. InterpretationThese results provide reassuring evidence that the three vaccines are effective at preventing Delta-variant COVID-19 in short term following vaccination campaign, and are most effective at preventing more serious illness. The findings of reduced duration of RT-PCR positivity and length of hospital stay associated with full vaccination suggests potential saving of health-care system resources.