Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study.
Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study.
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DOI：
10.1016/s0140-6736(21)02183-8
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发表时间：
2021-10-16
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影响因子：
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通讯作者：
McLaughlin JM
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作者：
Tartof SY;Slezak JM;Fischer H;Hong V;Ackerson BK;Ranasinghe ON;Frankland TB;Ogun OA;Zamparo JM;Gray S;Valluri SR;Pan K;Angulo FJ;Jodar L;McLaughlin JM
疫苗有效性研究尚未区分delta（B.1.617.2）变体和潜在免疫力减弱对观察到的SARS-CoV-2感染有效性降低的影响。我们的目的是评估BNT 162 b2（tozinameran，Pfizer-BioNTech）对SARS-CoV-2感染和COVID-19相关住院的总体和变体特异性有效性，自美国大型医疗保健系统的成员接种疫苗以来。在这项回顾性队列研究中，我们分析了医疗保健组织Kaiser Permanente Southern加州（CA，USA）成员的个人（≥12岁）的电子健康记录，以评估BNT 162 b2疫苗对SARS-CoV-2感染和COVID-19相关住院治疗长达6个月的有效性。参与者必须是该组织的成员或一年以上。结果包括SARS-CoV-2 PCR阳性检测和COVID-19相关住院。有效性计算基于校正的考克斯模型的风险比。本研究注册于ClinicalTrials.gov，NCT 04848584。在2020年12月14日至2021年8月8日期间，在4920549名接受资格评估的个人中，我们纳入了3436957人（中位年龄45岁[IQR 29-61]; 1799395 [52.4%]女性和1637394 [47.6%]男性）。 对于完全接种疫苗的个体，对SARS-CoV-2感染的有效性为73%（95%CI 72-74），对COVID-19相关住院的有效性为90%（89-92）。对感染的有效性从完全接种后第一个月的88%（95%CI 86-89）下降到5个月后的47%（43-51）。在测序的感染中，在完全接种后的第一个月内，针对delta变体感染的疫苗有效性较高（93% [95%CI 85-97]），但在4个月后下降至53% [39-65]。完全接种后第一个月对其他（非δ）变体的有效性也高达97%（95%CI 95-99），但在4-5个月时降至67%（4 - 5 -80）。在所有年龄段中，针对因感染δ变异体而住院的疫苗有效性总体较高（93% [95%CI 84-96]），最长达6个月。我们的研究结果支持BNT 162 b2在完全接种疫苗后约6个月内对住院治疗的高有效性，即使面对δ变体的广泛传播。随着时间的推移，疫苗对SARS-CoV-2感染的有效性降低可能主要是由于免疫力随着时间的推移而减弱，而不是δ变体逃避疫苗保护。辉瑞制药
Vaccine effectiveness studies have not differentiated the effect of the delta (B.1.617.2) variant and potential waning immunity in observed reductions in effectiveness against SARS-CoV-2 infections. We aimed to evaluate overall and variant-specific effectiveness of BNT162b2 (tozinameran, Pfizer–BioNTech) against SARS-CoV-2 infections and COVID-19-related hospital admissions by time since vaccination among members of a large US health-care system. In this retrospective cohort study, we analysed electronic health records of individuals (≥12 years) who were members of the health-care organisation Kaiser Permanente Southern California (CA, USA), to assess BNT162b2 vaccine effectiveness against SARS-CoV-2 infections and COVID-19-related hospital admissions for up to 6 months. Participants were required to have 1 year or more previous membership of the organisation. Outcomes comprised SARS-CoV-2 PCR-positive tests and COVID-19-related hospital admissions. Effectiveness calculations were based on hazard ratios from adjusted Cox models. This study was registered with ClinicalTrials.gov, NCT04848584. Between Dec 14, 2020, and Aug 8, 2021, of 4 920 549 individuals assessed for eligibility, we included 3 436 957 (median age 45 years [IQR 29–61]; 1 799 395 [52·4%] female and 1 637 394 [47·6%] male). For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95% CI 72–74) and against COVID-19-related hospital admissions was 90% (89–92). Effectiveness against infections declined from 88% (95% CI 86–89) during the first month after full vaccination to 47% (43–51) after 5 months. Among sequenced infections, vaccine effectiveness against infections of the delta variant was high during the first month after full vaccination (93% [95% CI 85–97]) but declined to 53% [39–65] after 4 months. Effectiveness against other (non-delta) variants the first month after full vaccination was also high at 97% (95% CI 95–99), but waned to 67% (45–80) at 4–5 months. Vaccine effectiveness against hospital admissions for infections with the delta variant for all ages was high overall (93% [95% CI 84–96]) up to 6 months. Our results provide support for high effectiveness of BNT162b2 against hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant. Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection. Pfizer.