mRNA Covid-19疫苗的安全性和有效性

2022年07月02日11:53:05 熱門 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.

嚴重急性呼吸綜合征冠狀病毒2型（SARS-CoV-2）感染及其引發的2019冠狀病毒疾病（Covid-19）在全球範圍內大流行，已使數千萬人深受其害。人們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.

在一項正在進行的跨國、安慰劑對照、觀察者盲法、關鍵療效試驗中，我們以1:1的比例隨機分配了16歲或16歲以上的人，間隔21天接受兩劑安慰劑或BNT162b2候選疫苗（每劑30微克）。BNT162b2是一種脂質納米顆粒製劑，經核苷修飾的RNA疫苗，編碼融合前穩定的膜錨定SARS-CoV-2全長刺突蛋白。主要終點是實驗室確認的Covid-19疫苗的有效性和安全性。

RESULTS 結果

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名參與者接受隨機分組，其中43448人接受了注射：21720人接受BNT162b2治療，21728人接受安慰劑治療。在第二次接受BNT162b2治療的受試者中，有8例在第二次給葯後至少7天出現了Covid-19，而在接受安慰劑治療的受試者中有162例；BNT162b2預防Covid-19的有效率為95%（95%可信區間為90.3~97.6）。在按年齡、性別、種族、族群、基線體重指數和共存條件定義的亞組中，觀察到類似的疫苗效力（通常為90%至100%）。在10例首次給葯後發病的嚴重Covid-19病例中，9例發生在安慰劑受試者，1例發生在BNT162b2受試者。BNT162b2的安全性特徵是短期、注射部位輕度至中度疼痛、疲勞和頭痛。嚴重不良事件的發生率較低，疫苗組和安慰劑組相似。

CONCLUSIONS 結論

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的兩劑方案可為16歲或以上的人群提供針對Covid-19的95％保護。平均2個月的安全性與其他病毒疫苗相似。