Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
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DOI：
10.1056/nejmoa2116298
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发表时间：
2022-01-06
期刊：
影响因子：
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通讯作者：
C4591007 Clinical Trial Group
中科院分区：
文献类型：
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作者：
Walter EB;Talaat KR;Sabharwal C;Gurtman A;Lockhart S;Paulsen GC;Barnett ED;Muñoz FM;Maldonado Y;Pahud BA;Domachowske JB;Simões EAF;Sarwar UN;Kitchin N;Cunliffe L;Rojo P;Kuchar E;Rämet M;Munjal I;Perez JL;Frenck RW Jr;Lagkadinou E;Swanson KA;Ma H;Xu X;Koury K;Mather S;Belanger TJ;Cooper D;Türeci Ö;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591007 Clinical Trial Group
12岁以下儿童迫切需要安全有效的2019冠状病毒病疫苗。正在进行一项1期剂量探索研究和一项正在进行的2 - 3期随机试验，以研究在6个月至11岁的儿童中间隔21天接种两剂BNT 162 b2疫苗的安全性、免疫原性和有效性。我们目前的结果为5至11岁的儿童。在2 - 3期试验中，受试者以2：1的比例随机分配，接受两剂BNT 162b2疫苗（在开放标签1期研究期间确定的剂量水平）或安慰剂。第二剂BNT162b2后1个月的免疫应答在免疫学上与来自两个30 μ g剂量BNT162b2的关键试验的16至25岁人群的免疫应答桥接。评估了第二剂疫苗接种后7天或更长时间内针对新冠肺炎的疫苗效力。在I期研究期间，共有48名5至11岁的儿童接受了10 μ g、20 μ g或30 μ g的BNT 162b2疫苗（每个剂量水平16名儿童）。根据反应原性和免疫原性，选择10 μ g剂量水平进行进一步研究。在2 - 3期试验中，共有2268名儿童被随机分配接受BNT162b2疫苗（1517名儿童）或安慰剂（751名儿童）。数据截止时，中位随访时间为2.3个月。在5至11岁的儿童中，与其他年龄组一样，BNT162b2疫苗具有良好的安全性。未发现与疫苗相关的严重不良事件。第二剂后一个月，严重急性呼吸综合征冠状病毒2的几何平均比值5至11岁人群中的SARS-CoV-2中和滴度与16至25岁人群中的中和滴度之比为1.04（95%置信区间[CI]，0.93 - 1.18），符合预先规定的免疫原性成功标准的比率（双侧95% CI下限，> 0.67;几何平均值比值点估计值，≥ 0.8）。BNT162b2疫苗接种者3例，安慰剂接种者16例，报告了第二剂接种后7天或更长时间内发生的新冠肺炎（疫苗有效性，90.7%; 95%CI，67.7至98.3）。由两次10 μ g剂量的BNT 162b2组成的Covid-19疫苗接种方案被发现在5至11岁的儿童中是安全的，免疫原性和有效的。（由BioNTech和Pfizer资助; www.example.com编号，NCT 04816643。）
Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. A phase 1, dose-finding study and an ongoing phase 2–3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2–3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2–3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.)