Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis.
Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis.
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DOI：
10.1186/s40249-021-00915-3
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发表时间：
2021-11-14
影响因子：
8.1
通讯作者：
Liu J
中科院分区：
文献类型：
--
作者：
Liu Q;Qin C;Liu M;Liu J
到目前为止，由于变种的出现，2019冠状病毒病（COVID-19）变得越来越激烈。需要通过疫苗接种快速群体免疫来阻断突变并防止出现可以完全逃脱免疫监视的变体。我们旨在系统评估COVID-19疫苗在真实的世界中的有效性和安全性，并为COVID-19疫苗的实际保护效果建立可靠的循证基础，特别是在随后以变异株为主的感染浪潮中。我们检索了PubMed，Embase和Web of Science，从开始到2021年7月22日。包括观察性研究，检查SARS-CoV-2疫苗接种人群的有效性和安全性。使用随机效应或固定效应模型估计疫苗有效性（VE）和接种后不良事件的发生率及其95%置信区间（CI）。共纳入58项研究（32项疫苗有效性研究和26项疫苗安全性研究）。单剂疫苗接种率为41%（95% CI：28-54%）有效预防SARS-CoV-2感染，52%（31-73%）有效预防症状性COVID-19，66%（50-81%）有效预防住院，45%（42-49%）有效预防重症监护室（ICU）入院，53%（15-91%）有效预防COVID-19相关死亡;两剂预防SARS-CoV-2感染的有效性分别为85%（81-89%），预防症状性COVID-19的有效性为97%（97-98%），预防住院的有效性为93%（89-96%），预防ICU入院的有效性为96%（93-98%），预防COVID-19相关死亡的有效性为95%（92-98%）。对于预防SARS-CoV-2感染的α变体，合并VE为85%（80-91%），β变体为75%（71-79%），γ变体为54%（35-74%），Delta变体为74%（62-85%）。不良事件的总体汇总发生率为1.5%（1.4-1.6%），严重不良事件为0.4/10000（0.2-0.5），接种后死亡为0.1/10000（0.1-0.2）。SARS-CoV-2疫苗具有令人放心的安全性，可以有效减少全球SARS-CoV-2导致的死亡、重症病例、症状性病例和感染。在全球大流行、SARS-CoV-2变异株不断出现的背景下，加快疫苗接种、提高疫苗接种覆盖率仍是最重要、最紧迫的事情，也是结束大流行的最终手段。在线版本包含补充材料，可通过10.1186/s40249-021-00915-3获得。
To date, coronavirus disease 2019 (COVID-19) becomes increasingly fierce due to the emergence of variants. Rapid herd immunity through vaccination is needed to block the mutation and prevent the emergence of variants that can completely escape the immune surveillance. We aimed to systematically evaluate the effectiveness and safety of COVID-19 vaccines in the real world and to establish a reliable evidence-based basis for the actual protective effect of the COVID-19 vaccines, especially in the ensuing waves of infections dominated by variants. We searched PubMed, Embase and Web of Science from inception to July 22, 2021. Observational studies that examined the effectiveness and safety of SARS-CoV-2 vaccines among people vaccinated were included. Random-effects or fixed-effects models were used to estimate the pooled vaccine effectiveness (VE) and incidence rate of adverse events after vaccination, and their 95% confidence intervals (CI). A total of 58 studies (32 studies for vaccine effectiveness and 26 studies for vaccine safety) were included. A single dose of vaccines was 41% (95% CI: 28–54%) effective at preventing SARS-CoV-2 infections, 52% (31–73%) for symptomatic COVID-19, 66% (50–81%) for hospitalization, 45% (42–49%) for Intensive Care Unit (ICU) admissions, and 53% (15–91%) for COVID-19-related death; and two doses were 85% (81–89%) effective at preventing SARS-CoV-2 infections, 97% (97–98%) for symptomatic COVID-19, 93% (89–96%) for hospitalization, 96% (93–98%) for ICU admissions, and 95% (92–98%) effective for COVID-19-related death, respectively. The pooled VE was 85% (80–91%) for the prevention of Alpha variant of SARS-CoV-2 infections, 75% (71–79%) for the Beta variant, 54% (35–74%) for the Gamma variant, and 74% (62–85%) for the Delta variant. The overall pooled incidence rate was 1.5% (1.4–1.6%) for adverse events, 0.4 (0.2–0.5) per 10 000 for severe adverse events, and 0.1 (0.1–0.2) per 10 000 for death after vaccination. SARS-CoV-2 vaccines have reassuring safety and could effectively reduce the death, severe cases, symptomatic cases, and infections resulting from SARS-CoV-2 across the world. In the context of global pandemic and the continuous emergence of SARS-CoV-2 variants, accelerating vaccination and improving vaccination coverage is still the most important and urgent matter, and it is also the final means to end the pandemic. The online version contains supplementary material available at 10.1186/s40249-021-00915-3.
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影响因子：
16.6
作者：
Azamgarhi T;Hodgkinson M;Shah A;Skinner JA;Hauptmannova I;Briggs TWR;Warren S
通讯作者：
Warren S
DOI：
10.1056/nejmoa2109072
发表时间：
2021-10-14
期刊：
The New England journal of medicine
影响因子：
--
作者：
Bergwerk M;Gonen T;Lustig Y;Amit S;Lipsitch M;Cohen C;Mandelboim M;Levin EG;Rubin C;Indenbaum V;Tal I;Zavitan M;Zuckerman N;Bar-Chaim A;Kreiss Y;Regev-Yochay G
通讯作者：
Regev-Yochay G
影响因子：
82.9
作者：
Chemaitelly, Hiam;Yassine, Hadi M.;Abu-Raddad, Laith J.
通讯作者：
Abu-Raddad, Laith J.
影响因子：
13.8
作者：
Chodick G;Tene L;Patalon T;Gazit S;Ben Tov A;Cohen D;Muhsen K
通讯作者：
Muhsen K
影响因子：
6.4
作者：
Bianchi, Francesco Paolo;Germinario, Cinzia Annatea;Stefanizzi, Pasquale
通讯作者：
Stefanizzi, Pasquale