mRNA Covid-19疫苗的安全性和有效性

2022年07月02日11:53:05 热门 1785

13 January 2021

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine （IF: NEJM, 70.670）

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615.

The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Absalon at Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, or at Judith .absalon@ Pfizer .com.

BACKGROUND 背景

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.

严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）感染及其引发的2019冠状病毒疾病（Covid-19）在全球范围内大流行，已使数千万人深受其害。人们迫切需要安全有效的疫苗。

METHODS 措施

In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 fulllength spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.

在一项正在进行的跨国、安慰剂对照、观察者盲法、关键疗效试验中，我们以1:1的比例随机分配了16岁或16岁以上的人，间隔21天接受两剂安慰剂或BNT162b2候选疫苗（每剂30微克）。BNT162b2是一种脂质纳米颗粒制剂，经核苷修饰的RNA疫苗，编码融合前稳定的膜锚定SARS-CoV-2全长刺突蛋白。主要终点是实验室确认的Covid-19疫苗的有效性和安全性。

RESULTS 结果

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

共有43548名参与者接受随机分组，其中43448人接受了注射：21720人接受BNT162b2治疗，21728人接受安慰剂治疗。在第二次接受BNT162b2治疗的受试者中，有8例在第二次给药后至少7天出现了Covid-19，而在接受安慰剂治疗的受试者中有162例；BNT162b2预防Covid-19的有效率为95%（95%可信区间为90.3~97.6）。在按年龄、性别、种族、族群、基线体重指数和共存条件定义的亚组中，观察到类似的疫苗效力（通常为90%至100%）。在10例首次给药后发病的严重Covid-19病例中，9例发生在安慰剂受试者，1例发生在BNT162b2受试者。BNT162b2的安全性特征是短期、注射部位轻度至中度疼痛、疲劳和头痛。严重不良事件的发生率较低，疫苗组和安慰剂组相似。

CONCLUSIONS 结论

A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.

BNT162b2的两剂方案可为16岁或以上的人群提供针对Covid-19的95％保护。平均2个月的安全性与其他病毒疫苗相似。