Comparative Safety of BNT162b2 and mRNA-1273 Vaccines in a Nationwide Cohort of US Veterans
Comparative Safety of BNT162b2 and mRNA-1273 Vaccines in a Nationwide Cohort of US Veterans
复制标题
DOI：
10.1001/jamainternmed.2022.2109
复制
发表时间：
2022-06-13
影响因子：
39
通讯作者：
Hernan, Miguel A.
中科院分区：
文献类型：
--
作者：
Dickerman, Barbra A.;Madenci, Arin L.;Hernan, Miguel A.
在随机试验中，接受BNT 162 b2（Pfizer-BioNTech）和mRNA-1273（Moderna Inc）疫苗的受试者发生不良事件的风险较低。然而，就我们所知，在更长时间的随访中，在更大和更多样化的人群中，缺乏对更广泛的潜在不良事件的安全性的头对头比较。目的在美国退伍军人事务部的国家卫生保健数据库中，在这项队列研究中，使用了在2021年1月4日至9月20日期间接受第一剂BNT 162 b2或mRNA-1273疫苗的美国退伍军人的电子健康记录。每种疫苗的接种者根据其风险因素以1：1的比例匹配。暴露接种BNT 162 b2疫苗，第二次剂量计划在21天后，或mRNA-1273疫苗，第二次剂量计划在28天后。主要结果和测量一个大的潜在不良事件的面板进行了评估;面板包括神经系统事件。血液学事件、出血性卒中、缺血性卒中。心肌梗塞、其他血栓栓塞事件、心肌炎或心包炎、心律失常、肾损伤、阑尾炎、自身免疫事件、带状疱疹或单纯疱疹、关节炎或关节病和肺炎。超过38周的风险估计usingthe Kaplan-Meier estimator.Results在433672人包括在匹配的疫苗组，中位年龄为69岁（IQR，60-74岁），93%的人是男性，20%是黑人。在施用BNT 162 b2或mRNA-1273疫苗后，不良事件的估计38周风险通常较低。与mRNA-1273组相比，BNT 162 b2组每10000人有10.9起事件缺血性卒中（95% CI，1.9-17.4起事件），14.8起事件心肌梗死（95% CI，7.9-21.8起事件），11.3起事件其他血栓栓塞事件（95% CI，3.4-17.7起事件）和肾损伤17.1起事件（95% CI，8.8-30.2起事件）。按年龄（= 7-70岁）和种族（黑人，白色）定义的亚组之间的估计值基本相似，但老年人和白色人之间缺血性卒中、老年人肾损伤和黑人中其他血栓栓塞事件的风险差异幅度更大。在首次接种后42天内观察到两种疫苗之间的微小差异，结论和相关性该队列研究的结果表明，在BNT 162 b2或mRNA-1273疫苗的第一次剂量的14天内，不良事件的风险几乎没有差异，并且小剂量BNT 162 b2或mRNA-1273疫苗的第一次剂量的14天内，不良事件的风险几乎没有差异。首次给药后42天内的幅度差异。在两个疫苗组中，38周的不良事件风险都很低，尽管mRNA-1273疫苗接种者的风险低于BNT 162 b2疫苗接种者。尽管主要分析旨在检测与SARS-CoV-2感染无关的安全性事件，但不能排除这些差异可能部分由BNT 162 b2疫苗预防SARS-CoV-2感染后遗症的有效性低于mRNA-1273疫苗来解释。这些发现可能有助于在未来的疫苗接种活动中做出决策。
IMPORTANCE The risk of adverse events has been found to be low for participants receiving the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna Inc) vaccines in randomized trials. However, a head-to-head comparison of their safety for a broader range of potential adverse events over longer follow-up and in larger and more diverse populations is lacking, to our knowledge.OBJECTIVE To compare the head-to-head safety in terms of risk of adverse events of the BNT162b2 and mRNA-1273 vaccines in the national health care databases of the US Department of Veterans Affairs, the largest integrated health care system in the US.DESIGN, SETTING, AND PARTICIPANTS In this cohort study, the electronic health records of US veterans who received a first dose of the BNT162b2 or mRNA-1273 vaccine between January 4 and September 20, 2021, were used. Recipients of each vaccine were matched in a 1:1 ratio according to their risk factors.EXPOSURES Vaccination with either the BNT162b2 vaccine, with a second dose scheduled 21 days later, or the mRNA-1273 vaccine, with a second dose scheduled 28 days later.MAIN OUTCOMES AND MEASURES A large panel of potential adverse events was evaluated; the panel included neurologic events. hematologic events, hemorrhagic stroke, ischemic stroke. myocardial infarction, other thromboembolic events, myocarditis or pericarditis, arrhythmia, kidney injury, appendicitis, autoimmune events, herpes zoster or simplex, arthritis or arthropathy, and pneumonia. Risks over 38 weeks were estimated usingthe Kaplan-Meier estimator.RESULTS Among 433 672 persons included in the matched vaccine groups, the median age was 69 years (IQR, 60-74 years), 93% of individuals were male, and 20% were Black. Estimated 38-week risks of adverse events were generally low after administration of either the BNT162b2 or the mRNA-1273 vaccine. Compared with the mRNA-1273 group, the BNT162b2 group had an excess per 10 000 persons of 10,9 events (95% CI, 1.9-17.4 events) of ischemic stroke, 14.8 events (95% CI, 7.9-21.8 events) of myocardial infarction, 11.3 events (95% CI, 3.4-17.7 events) of other thromboembolic events, and 17.1 events (95% CI, 8.8-30.2 events) of kidney injury. Estimates were largely similar among subgroups defined by age (= 7-70 years) and race (Black, White), but there were higher magnitudes of risk differences of ischemic stroke among older persons and White persons, kidney injury among older persons, and other thromboembolic events among Black persons. Small-magnitude differences between the 2 vaccines were seen within 42 days of the first dose, and few differences were seen within 14 days of the first dose.CONCLUSIONS AND RELEVANCE The findings of this cohort study suggest that there were few differences in risk of adverse events within 14 days of the first dose of either the BNT162b2 or the mRNA-1273 vaccine and small-magnitude differences within 42 days of the first dose. The 38-week risks of adverse events were low in both vaccine groups, although risks were lower for recipients of the mRNA-1273 vaccine than for recipients of the BNT162b2 vaccine. Although the primary analysis was designed to detect safety events unrelated to SARS-CoV-2 infection, the possibility that these differences may partially be explained by a lower effectiveness of the BNT162b2 vaccine in preventing the sequelae of SARS-CoV-2 infection compared with the mRNA-1273 vaccine could not be ruled out. These findings may help inform decision-making in future vaccination campaigns.