2分钟看懂 新冠核酸疫苗BNT162b2的安全性和有效性
以下文章起源于NEJM医学前沿 ，，，作者NEJM医学前沿
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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
朗诵者：：：Dr. Stephen Morrissey, NEJM执行主编
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WHO于2020年3月11日颁发COVID-19构玉成球大盛行以来，，，全球已罕见千万人患病�！Ｎ颐秦叫璋踩�、有效的疫苗�！６淌悠抵凶芙崃诵碌淖暄蟹⑾��！�
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BNT162b2 COVID-19 mRNA疫苗的安全性和有效性
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
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摘 要
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布景
SARS-CoV-2习染及其所致疾病COVID-19已在这次的全球大盛行中累及数千万人�！Ｎ颐腔鸺北匾踩行У囊呙��！�
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.
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步骤
在一项仍在进行的多国、慰藉剂对照、观察者设盲的关键有效性试验中，，，我们以1:1比例将≥16岁的参加者随机分组，，，两组别离距离21天接种两剂慰藉剂或BNT162b2候选疫苗（每剂30 μg）�！NT162b2是一种脂质纳米颗粒制成、核苷修饰RNA疫苗，，，可能编码融合前不变、膜锚定的SARS-CoV-2全长棘突蛋白�！Ｖ匾盏闶且呙缭し繡OVID-19（需经尝试室证实）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.
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了局
共计43,548例参加者被随机分组，，，其中43,448例接受了注射：：：21,720例注射了BNT162b2，，，21,728例注射了慰藉剂�！NT162b2组8例参加者和慰藉剂组162例参加者产生了接种第二剂至少7日后发病的COVID-19；；BNT162b2预防COVID-19的有效率为95%（95%可信区间[credible interval]，，，90.3~97.6）�！Ｔ谄揪荽呵�、性别、人种、族群、基线体质指数和是否患归并症界说的各亚组中，，，我们均观察到了类似的疫苗有效率（通常为90%~100%）�！Ｔ诮又值谝患梁蟛�10例重症COVID-19中，，，9例产生于慰藉剂组，，，1例产生于BNT162b2组�！NT162b2的安全性特点蕴含短期的轻度至中度注射部位疼痛、委顿和头痛�！Ｒ呙缱楹臀拷寮磷榈难现夭涣际挛癫示系颓依嗨��！�
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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.
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结论
16岁及以上人群接种两剂BNT162b2后在预防COVID-19方面达到了95%的有效率�！Ｖ形�2个月期间的安全性与其他病毒疫苗类似�！＃ㄓ葿ioNTech和辉瑞赞助；；在ClinicalTrials.gov注册号为NCT04368728�！＃�
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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.)
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Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. DOI:10.1056/NEJMoa2034577
