Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data.
Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data.
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DOI：
10.1016/s0140-6736(21)00947-8
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发表时间：
2021-05-15
期刊：
影响因子：
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通讯作者：
Alroy-Preis S
中科院分区：
文献类型：
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作者：
Haas EJ;Angulo FJ;McLaughlin JM;Anis E;Singer SR;Khan F;Brooks N;Smaja M;Mircus G;Pan K;Southern J;Swerdlow DL;Jodar L;Levy Y;Alroy-Preis S
辉瑞BioNTech mRNA COVID-19疫苗BNT 162 b2（国际非专利名称tozinameran）在以色列获得紧急使用许可后，以色列卫生部（MoH）发起了一项运动，为650万16岁及以上的以色列居民进行免疫接种。我们估计了两剂BNT 162 b2对一系列SARS-CoV-2结果的实际有效性，并评估了广泛引入疫苗后全国范围内的公共卫生影响。我们使用全国疫苗接种运动前4个月的国家监测数据，以确定实验室确认的SARS-CoV-2感染事件和结果，以及以色列16岁及以上居民的疫苗接种情况。针对SARS-CoV-2结果的疫苗有效性（无症状感染者、有症状感染者、与COVID-19相关的住院治疗、重症或危重住院治疗，和死亡）的发病率计算的基础上，在完全接种疫苗的个人（定义为自接种第二剂疫苗以来已过去7天的人）与未接种疫苗的人相比（未接受任何剂量疫苗），使用针对年龄组（16-24、25-34、35-44、45-54、55-64、65-74、75-84和≥85岁）、性别和日历周调整的负二项回归模型。在全国范围内SARS-CoV-2阳性标本的毒力样本中，PCR检测中刺突基因靶点失败的比例被用来估计B.1.1.7变体的流行。在分析期间（2021年1月24日至4月3日），16岁或以上人群中有232，268例SARS-CoV-2感染、7，694例COVID-19住院治疗、4，481例重度或危重COVID-19住院治疗以及1，113例COVID-19死亡。截至2021年4月3日，在6538911名16岁及以上人群中，有4714932人（72.1%）接种了两剂BNT 162 b2疫苗。第二次接种后7天或更长时间的疫苗有效性校正估计值为95.3%（95% CI 94.9 - 95.7;未接种疫苗的发病率为91.5/10万人天，而完全接种疫苗的个体为3.1/10万人天），对SARS-CoV-2感染的91.5%（90·7-92·2; 40·9 vs 1·8/10万人日），对无症状SARS-CoV-2感染者，97·0%（96·7-97·2; 32·5 vs 0·8/10万人日），针对有症状的COVID-19，97·2%（96.8 - 97.5; 4.6 vs 0.3/10万人日），预防COVID-19相关住院，97.5%（97.1 - 97.8; 2.7 vs 0.2/10万人日），96.7%（96·0-97·3; 0·6 vs 0·1/10万人日）。在所有年龄组中，随着疫苗覆盖率的增加，SARS-CoV-2结局的发生率下降。在8472份检测样本中，有8006份显示出刺突基因靶点失败，估计SARS-CoV-2感染者中B.1.1.7变异体的患病率为94.5%。两剂BNT 162 b2在所有年龄组（≥16岁，包括≥85岁的老年人）中均高度有效，可预防症状性和无症状性SARS-CoV-2感染以及COVID-19相关住院、严重疾病和死亡，包括由B.1.1.7 SARS-CoV-2变体引起的疾病。SARS-CoV-2的发病率随着疫苗覆盖率的提高而显著和持续下降。这些发现表明，COVID-19疫苗接种有助于控制疫情。没有。
Following the emergency use authorisation of the Pfizer–BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6·5 million residents of Israel aged 16 years and older. We estimated the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine. We used national surveillance data from the first 4 months of the nationwide vaccination campaign to ascertain incident cases of laboratory-confirmed SARS-CoV-2 infections and outcomes, as well as vaccine uptake in residents of Israel aged 16 years and older. Vaccine effectiveness against SARS-CoV-2 outcomes (asymptomatic infection, symptomatic infection, and COVID-19-related hospitalisation, severe or critical hospitalisation, and death) was calculated on the basis of incidence rates in fully vaccinated individuals (defined as those for whom 7 days had passed since receiving the second dose of vaccine) compared with rates in unvaccinated individuals (who had not received any doses of the vaccine), with use of a negative binomial regression model adjusted for age group (16–24, 25–34, 35–44, 45–54, 55–64, 65–74, 75–84, and ≥85 years), sex, and calendar week. The proportion of spike gene target failures on PCR test among a nationwide convenience-sample of SARS-CoV-2-positive specimens was used to estimate the prevelance of the B.1.1.7 variant. During the analysis period (Jan 24 to April 3, 2021), there were 232 268 SARS-CoV-2 infections, 7694 COVID-19 hospitalisations, 4481 severe or critical COVID-19 hospitalisations, and 1113 COVID-19 deaths in people aged 16 years or older. By April 3, 2021, 4 714 932 (72·1%) of 6 538 911 people aged 16 years and older were fully vaccinated with two doses of BNT162b2. Adjusted estimates of vaccine effectiveness at 7 days or longer after the second dose were 95·3% (95% CI 94·9–95·7; incidence rate 91·5 per 100 000 person-days in unvaccinated vs 3·1 per 100 000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91·5% (90·7–92·2; 40·9 vs 1·8 per 100 000 person-days) against asymptomatic SARS-CoV-2 infection, 97·0% (96·7–97·2; 32·5 vs 0·8 per 100 000 person-days) against symptomatic COVID-19, 97·2% (96·8–97·5; 4·6 vs 0·3 per 100 000 person-days) against COVID-19-related hospitalisation, 97·5% (97·1–97·8; 2·7 vs 0·2 per 100 000 person-days) against severe or critical COVID-19-related hospitalisation, and 96·7% (96·0–97·3; 0·6 vs 0·1 per 100 000 person-days) against COVID-19-related death. In all age groups, as vaccine coverage increased, the incidence of SARS-CoV-2 outcomes declined. 8006 of 8472 samples tested showed a spike gene target failure, giving an estimated prevalence of the B.1.1.7 variant of 94·5% among SARS-CoV-2 infections. Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic. None.