Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
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DOI：
10.1056/nejmoa2110345
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发表时间：
2021-11-04
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：
Thomas SJ;Moreira ED Jr;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Polack FP;Zerbini C;Bailey R;Swanson KA;Xu X;Roychoudhury S;Koury K;Bouguermouh S;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Yang Q;Liberator P;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Gruber WC;Jansen KU;C4591001 Clinical Trial Group
BNT 162 b2是一种脂质纳米颗粒配制的核苷修饰的RNA疫苗，编码融合前稳定的膜锚定的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）全长刺突蛋白。BNT 162 b2对2019冠状病毒病（Covid-19）非常有效，目前已在全球范围内获得批准、有条件批准或授权紧急使用。在初始授权时，无法获得疫苗接种后2个月以上的数据。在一项正在进行的安慰剂对照、双盲、多国、关键疗效试验中，我们随机分配了44，165名16岁或以上的参与者和2264名12至15岁的参与者，接受两次30 μg剂量的BNT 162 b2或安慰剂，间隔21天。试验终点是疫苗对实验室确认的Covid-19的有效性和安全性，这两项都是在接种疫苗后6个月进行评估的。BNT 162 b2仍然是安全的，并且具有可接受的不良事件特征。很少有参与者发生导致退出试验的不良事件。在6个月的随访中，在没有既往SARS-CoV-2感染证据的参与者中，疫苗对COVID-19的有效性为91.3%（95%置信区间[CI]，89.0至93.2）。疫苗效力逐渐下降。在不同国家和不同年龄、性别、种族或民族的人群中，以及在没有既往感染SARS-CoV-2证据的参与者中存在Covid-19风险因素的人群中，疫苗的有效性为86%至100%。疫苗对严重疾病的有效性为96.7%（95% CI，80.3至99.9）。在南非，关注的SARS-CoV-2变异体B.1.351（或β）占主导地位，观察到疫苗有效性为100%（95% CI，53.5至100）。通过6个月的随访，尽管疫苗效力逐渐下降，但BNT 162 b2具有良好的安全性，并且在预防Covid-19方面非常有效。（由BioNTech和辉瑞资助; ClinicalTrials.gov编号，NCT 04368728。）
BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)