美国辉瑞制药公司Judith Absalon, M.D.团队研究了BNT162b2 mRNA Covid-19疫苗的安全性和有效性。2020年12月10日，该研究发表在《新英格兰医学杂志》上。

SARS-CoV-2感染和由此产生的Covid-19全球大流行折磨着数千万人。因此迫切需要安全有效的疫苗。

在这项正在进行的跨国、安慰剂对照、观察者盲的关键疗效试验中，研究组招募了43548名年龄在16岁及以上的参与者，将其按1：1随机分配，间隔21天接种两剂安慰剂或BNT162b2候选疫苗（每剂30微克）。

BNT162b2是脂质纳米颗粒配制的，经核苷修饰的RNA疫苗，编码一种融合前稳定的，膜锚定的SARS-CoV-2全长刺突蛋白。主要终点是疫苗针对实验室确诊的Covid-19的保护疗效和安全性。

43548名参与者中有43448名接种，其中21720名接种了BNT162b2，21728名接种了安慰剂。在第二次接种BNT162b2治疗的受试者中，至少有7例在二次接种7天后确诊Covid-19，而在接种安慰剂的受试者中有162例；BNT162b2预防Covid-19的有效性为95％。

在根据年龄、性别、种族、族裔、基线身体质量指数和存在基础疾病而定义的亚组中，研究组观察到相似的疫苗疗效（通常为90％至100％）。接种首剂后共有10例患者发生严重Covid-19，其中安慰剂接种者中有9例，BNT162b2接种者中有1例。BNT162b2的不良反应包括注射部位的短期、轻度至中度疼痛，疲劳和头痛。严重不良事件的发生率较低，在疫苗组和安慰剂组中相差不大。

研究结果表明，BNT162b2的两剂方案可为16岁及以上的人群提供针对Covid-19的95％的保护率。

附：英文原文

Title: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Author: Fernando P. Polack, M.D.,, Stephen J. Thomas, M.D.,, Nicholas Kitchin, M.D.,, Judith Absalon, M.D.,, Alejandra Gurtman, M.D.,, Stephen Lockhart, D.M.,, John L. Perez, M.D.,, Gonzalo Pérez Marc, M.D.,, Edson D. Moreira, M.D.,, Cristiano Zerbini, M.D.,, Ruth Bailey, B.Sc.,, Kena A. Swanson, Ph.D.,, Satrajit Roychoudhury, Ph.D.,, Kenneth Koury, Ph.D.,, Ping Li, Ph.D.,, Warren V. Kalina, Ph.D.,, David Cooper, Ph.D.,, Robert W. Frenck, Jr., M.D.,, Laura L. Hammitt, M.D.,, zlem Türeci, M.D.,, Haylene Nell, M.D.,, Axel Schaefer, M.D.,, Serhat ünal, M.D.,, Dina B. Tresnan, D.V.M., Ph.D.,, Susan Mather, M.D.,, Philip R. Dormitzer, M.D., Ph.D.,, Uur ahin, M.D.,, Kathrin U. Jansen, Ph.D.,, and William C. Gruber, M.D.

Issue&Volume: 2020-12-10

Abstract:

BACKGROUND

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.

METHODS

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 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.

RESULTS

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.

CONCLUSIONS

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.

DOI: 10.1056/NEJMoa2034577

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577