Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.
Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.
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DOI：
10.1056/nejmoa2107456
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发表时间：
2021-07-15
期刊：
影响因子：
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通讯作者：
C4591001 Clinical Trial Group
中科院分区：
文献类型：
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作者：
Frenck RW Jr;Klein NP;Kitchin N;Gurtman A;Absalon J;Lockhart S;Perez JL;Walter EB;Senders S;Bailey R;Swanson KA;Ma H;Xu X;Koury K;Kalina WV;Cooper D;Jennings T;Brandon DM;Thomas SJ;Türeci Ö;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
直到最近，针对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的疫苗尚未获准在 16 岁以下人群中紧急使用。需要安全、有效的疫苗来保护这一人群，促进面对面学习和社交，并促进群体免疫。在这项正在进行的跨国、安慰剂对照、观察者盲法试验中，我们以 1:1 的比例随机分配参与者接受两次注射，每次注射 30 μg BNT162b2 或安慰剂，间隔 21 天。 12 至 15 岁参与者对 BNT162b2 的免疫反应与 16 至 25 岁参与者相比的非劣效性是免疫原性目标。在 12 至 15 岁队列中评估了针对已确诊的 2019 年冠状病毒病（Covid-19；发病，第 2 剂后≥7 天）的安全性（反应性和不良事件）和疗效。总体而言，2260 名 12 至 15 岁青少年接受了注射； 1131 人接受了 BNT162b2，1129 人接受了安慰剂。正如在其他年龄组中发现的那样，BNT162b2 具有良好的安全性和副作用，主要是短暂的轻度至中度反应原性（主要是注射部位疼痛[79% 至 86% 的参与者]、疲劳[60% 至 66%] 和头痛[55% 至 65%]）；没有发生与疫苗相关的严重不良事件，总体严重不良事件也很少。 12至15岁参与者相对于16至25岁参与者第2剂后SARS-CoV-2 50%中和滴度的几何平均比率为1.76（95%置信区间[CI]，1.47至2.10），符合两侧95%置信区间下限大于0.67的非劣效性标准，表明更大12 至 15 岁群体的反应。在之前没有 SARS-CoV-2 感染证据的参与者中，BNT162b2 接受者中没有发现在第 2 剂给药后 7 天或以上发病的 Covid-19 病例，而安慰剂接受者中出现了 16 例。观察到的疫苗效力为 100%（95% CI，75.3 至 100）。 BNT162b2 疫苗在 12 至 15 岁的接种者中具有良好的安全性，比年轻人产生更强的免疫反应，并且对 Covid-19 非常有效。 （由 BioNTech 和辉瑞资助；C4591001 ClinicalTrials.gov 编号，NCT04368728。）
Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity. In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed. Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100). The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.)