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BNT162b2 COVID-19疫苗的安全性和有效性

Safety and Efficacy of the BNT162b2 Covid-19 Vaccine

2020年12月31日

朗讀者：Dr. Stephen Morrissey, NEJM執行主編

WHO於2020年3月11日宣布COVID-19構成全球大流行以來，全球已有數千萬人患病。我們亟需安全、有效的疫苗。短視頻中總結了新的研究發現。

BNT162b2 COVID-19 mRNA疫苗的安全性和有效性

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

摘 要

背景

SARS-CoV-2感染及其所致疾病COVID-19已在此次的全球大流行中累及數千萬人。我們迫切需要安全有效的疫苗。

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.

方法

在壹項仍在進行的多國、安慰劑對照、觀察者設盲的關鍵有效性試驗中，我們以1:1比例將≥16歲的參與者隨機分組，兩組分別間隔21天接種兩劑安慰劑或BNT162b2候選疫苗（每劑30 μg）。BNT162b2是壹種脂質納米顆粒制成、核苷修飾RNA疫苗，能夠編碼融合前穩定、膜錨定的SARS-CoV-2全長棘突蛋白。主要終點是疫苗預防COVID-19（需經實驗室證實）的有效性和安全性。

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.

結果

共計43,548例參與者被隨機分組，其中43,448例接受了註射：21,720例註射了BNT162b2，21,728例註射了安慰劑。BNT162b2組8例參與者和安慰劑組162例參與者發生了接種第二劑至少7日後發病的COVID-19；BNT162b2預防COVID-19的有效率為95%（95%可信區間[credible interval]，90.3~97.6）。在根據年齡、性別、人種、族群、基線體質指數和是否患合並癥定義的各亞組中，我們均觀察到了相似的疫苗有效率（壹般為90%~100%）。在接種第壹劑後發生的10例重癥COVID-19中，9例發生於安慰劑組，1例發生於BNT162b2組。BNT162b2的安全性特征包括短期的輕度至中度註射部位疼痛、疲勞和頭痛。疫苗組和安慰劑組的嚴重不良事件發生率均較低且相似。

Result

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.

結論

16歲及以上人群接種兩劑BNT162b2後在預防COVID-19方面達到了95%的有效率。中位2個月期間的安全性與其他病毒疫苗相似。（由BioNTech和輝瑞資助；在ClinicalTrials.gov註冊號為NCT04368728。）

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. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. DOI:10.1056/NEJMoa2034577