Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study.
Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study.
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DOI：
10.1016/s0140-6736(21)02249-2
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发表时间：
2021-12-04
期刊：
影响因子：
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通讯作者：
Balicer RD
中科院分区：
文献类型：
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作者：
Barda N;Dagan N;Cohen C;Hernán MA;Lipsitch M;Kohane IS;Reis BY;Balicer RD
许多国家正在经历COVID-19的复苏，主要是由SARS-CoV-2的delta（B.1.617.2）变体驱动的。作为回应，这些国家正在考虑接种第三剂mRNA COVID-19疫苗作为加强剂，以解决随着时间的推移免疫力可能减弱以及对delta变体有效性降低的问题。我们的目标是利用以色列最大的卫生保健组织的数据库来评估第三剂BNT 162 b2 mRNA疫苗预防严重COVID-19后果的有效性。Clalit Health Services为超过一半的以色列人口提供强制医疗保健覆盖，使用Clalit Health Services的数据，将2020年7月30日至2021年9月23日期间接受第三剂疫苗的个人与人口统计学和临床相似的人进行匹配（1：1）没有接受第三剂疫苗的对照组。符合条件的参与者在招募日期前至少5个月接受了第二剂疫苗，先前没有记录的SARS-CoV-2感染，并且在招募前3天内没有与卫生保健系统接触。作为卫生保健工作者、居住在长期护理设施中或因医疗原因被限制在家中的个人被排除在外。主要结局为COVID-19相关入院、严重疾病和COVID-19相关死亡。使用Kaplan-Meier估计量将每种结局的第三次给药有效性估计为1-风险比。 1 158 269人有资格被纳入第三剂量组。 匹配后，第三剂量组和对照组各包括728321人。 参与者的中位年龄为52岁（IQR 37-68），51%为女性。两组的中位随访时间为13天（IQR 6-21）。与至少5个月前仅接种两剂相比，在接种第三剂后至少7天评估疫苗有效性，估计为93%（2剂231起事件vs 3剂29起事件; 95% CI 88-97）入院时，92%（157对17起事件; 82-97）为严重疾病，81%（44对7起事件; 59-97）为COVID-19相关死亡。我们的研究结果表明，与至少5个月前仅接受两剂疫苗相比，第三剂BNT 162 b2 mRNA疫苗可有效保护个体免受严重的COVID-19相关后果。Ivan和Francesca Berkowitz家庭生活实验室合作在哈佛医学院和Clalit研究所。
Many countries are experiencing a resurgence of COVID-19, driven predominantly by the delta (B.1.617.2) variant of SARS-CoV-2. In response, these countries are considering the administration of a third dose of mRNA COVID-19 vaccine as a booster dose to address potential waning immunity over time and reduced effectiveness against the delta variant. We aimed to use the data repositories of Israel's largest health-care organisation to evaluate the effectiveness of a third dose of the BNT162b2 mRNA vaccine for preventing severe COVID-19 outcomes. Using data from Clalit Health Services, which provides mandatory health-care coverage for over half of the Israeli population, individuals receiving a third vaccine dose between July 30, 2020, and Sept 23, 2021, were matched (1:1) to demographically and clinically similar controls who did not receive a third dose. Eligible participants had received the second vaccine dose at least 5 months before the recruitment date, had no previous documented SARS-CoV-2 infection, and had no contact with the health-care system in the 3 days before recruitment. Individuals who are health-care workers, live in long-term care facilities, or are medically confined to their homes were excluded. Primary outcomes were COVID-19-related admission to hospital, severe disease, and COVID-19-related death. The third dose effectiveness for each outcome was estimated as 1 – risk ratio using the Kaplan-Meier estimator. 1 158 269 individuals were eligible to be included in the third dose group. Following matching, the third dose and control groups each included 728 321 individuals. Participants had a median age of 52 years (IQR 37–68) and 51% were female. The median follow-up time was 13 days (IQR 6–21) in both groups. Vaccine effectiveness evaluated at least 7 days after receipt of the third dose, compared with receiving only two doses at least 5 months ago, was estimated to be 93% (231 events for two doses vs 29 events for three doses; 95% CI 88–97) for admission to hospital, 92% (157 vs 17 events; 82–97) for severe disease, and 81% (44 vs seven events; 59–97) for COVID-19-related death. Our findings suggest that a third dose of the BNT162b2 mRNA vaccine is effective in protecting individuals against severe COVID-19-related outcomes, compared with receiving only two doses at least 5 months ago. The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.