Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans.
Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans.
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DOI：
10.1056/nejmoa2115463
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发表时间：
2022-01-13
期刊：
影响因子：
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通讯作者：
Hernán MA
中科院分区：
文献类型：
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作者：
Dickerman BA;Gerlovin H;Madenci AL;Kurgansky KE;Ferolito BR;Figueroa Muñiz MJ;Gagnon DR;Gaziano JM;Cho K;Casas JP;Hernán MA
基于信使RNA （mRNA）的疫苗BNT162b2和mRNA-1273对2019冠状病毒病（Covid-19）的有效性超过90%。然而，它们对不同人群的一系列结果的相对有效性尚不清楚。我们使用美国退伍军人的电子健康记录模拟了一项目标试验，这些退伍军人在2021年1月4日至5月14日期间接受了第一剂BNT162b2或mRNA-1273疫苗，这段时间以SARS-CoV-2 B.1.1.7 （alpha）变体为主。我们根据疫苗接种者的危险因素，将他们按1:1的比例进行匹配。结果包括记录在案的严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）感染、症状性Covid-19、因Covid-19住院、因Covid-19入住重症监护病房（ICU）以及因Covid-19死亡。我们使用Kaplan-Meier估计器估计风险。为了评估B.1.617.2 （delta）变体的影响，我们模拟了第二项目标试验，该试验涉及2021年7月1日至9月20日接种疫苗的退伍军人。每个疫苗组包括219,842人。在以α变异优势为标志的24周随访期间，BNT162b2组记录在案的感染风险估计为每1000人5.75事件（95%置信区间[CI]， 5.39至6.23），mRNA-1273组为每1000人4.52事件（95% CI， 4.17至4.84）。与mRNA-1273相比，BNT162b2每1000人的额外事件数在记录感染中为1.23 (95% CI， 0.72至1.81)，在症状性Covid-19中为0.44 (95% CI， 0.25至0.70)，在Covid-19住院中为0.55 (95% CI， 0.36至0.83)，在Covid-19住院中为0.10 (95% CI， 0.00至0.26)，在Covid-19死亡中为0.02 （95% CI, - 0.06至0.12）。在以δ变异优势为标志的12周随访期间，记录感染的相应超额风险（BNT162b2 vs. mRNA-1273）为每1000人6.54例事件（95% CI, - 2.58至11.82）。接种mRNA-1273或BNT162b2疫苗后，24周发生Covid-19结局的风险较低，尽管mRNA-1273疫苗的风险低于BNT162b2疫苗。这种模式在以α型和δ型变体为主的时期是一致的。（由退伍军人事务部和其他机构资助。）
The messenger RNA (mRNA)–based vaccines BNT162b2 and mRNA-1273 are more than 90% effective against coronavirus disease 2019 (Covid-19). However, their comparative effectiveness for a range of outcomes across diverse populations is unknown. We emulated a target trial using the electronic health records of U.S. veterans who received a first dose of the BNT162b2 or mRNA-1273 vaccine between January 4 and May 14, 2021, during a period marked by predominance of the SARS-CoV-2 B.1.1.7 (alpha) variant. We matched recipients of each vaccine in a 1:1 ratio according to their risk factors. Outcomes included documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptomatic Covid-19, hospitalization for Covid-19, admission to an intensive care unit (ICU) for Covid-19, and death from Covid-19. We estimated risks using the Kaplan–Meier estimator. To assess the influence of the B.1.617.2 (delta) variant, we emulated a second target trial that involved veterans vaccinated between July 1 and September 20, 2021. Each vaccine group included 219,842 persons. Over 24 weeks of follow-up in a period marked by alpha-variant predominance, the estimated risk of documented infection was 5.75 events per 1000 persons (95% confidence interval [CI], 5.39 to 6.23) in the BNT162b2 group and 4.52 events per 1000 persons (95% CI, 4.17 to 4.84) in the mRNA-1273 group. The excess number of events per 1000 persons for BNT162b2 as compared with mRNA-1273 was 1.23 (95% CI, 0.72 to 1.81) for documented infection, 0.44 (95% CI, 0.25 to 0.70) for symptomatic Covid-19, 0.55 (95% CI, 0.36 to 0.83) for hospitalization for Covid-19, 0.10 (95% CI, 0.00 to 0.26) for ICU admission for Covid-19, and 0.02 (95% CI, −0.06 to 0.12) for death from Covid-19. The corresponding excess risk (BNT162b2 vs. mRNA-1273) of documented infection over 12 weeks of follow-up in a period marked by delta-variant predominance was 6.54 events per 1000 persons (95% CI, −2.58 to 11.82). The 24-week risk of Covid-19 outcomes was low after vaccination with mRNA-1273 or BNT162b2, although risks were lower with mRNA-1273 than with BNT162b2. This pattern was consistent across periods marked by alpha- and delta-variant predominance. (Funded by the Department of Veterans Affairs and others.)