CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
JAMA Intern Med. 2022 Jul 1;182(7):739-746. doi: 10.1001/jamainternmed.2022.2109.
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.
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.
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.
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 using the Kaplan-Meier estimator.
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 (<40, 40-69, and ≥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.
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.
在随机试验中，接受 BNT162b2（辉瑞-生物科技）和 mRNA-1273（莫德纳公司）疫苗的参与者的不良事件风险被发现较低。然而，我们所知，对于更广泛的潜在不良事件，在更长的随访时间和更大、更多样化的人群中，尚未对头对头比较它们的安全性。
比较美国退伍军人事务部国家医疗保健数据库中 BNT162b2 和 mRNA-1273 疫苗在不良事件风险方面的头对头安全性，该数据库是美国最大的综合性医疗保健系统。
设计、设置和参与者：在这项队列研究中，使用了 2021 年 1 月 4 日至 9 月 20 日期间接受 BNT162b2 或 mRNA-1273 疫苗第一剂的美国退伍军人的电子健康记录。根据他们的风险因素，每种疫苗的接种者以 1:1 的比例进行匹配。
接种 BNT162b2 疫苗，第二剂疫苗在 21 天后接种，或接种 mRNA-1273 疫苗，第二剂疫苗在 28 天后接种。
评估了大量潜在不良事件的面板；该面板包括神经系统事件、血液事件、出血性中风、缺血性中风、心肌梗死、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、肺炎。使用 Kaplan-Meier 估计器估计 38 周内的风险。
在匹配的疫苗组中，433672 人中有 38 周不良事件的估计风险通常较低，中位年龄为 69 岁（IQR，60-74 岁），93%的个体为男性，20%为黑人。与 mRNA-1273 组相比，BNT162b2 组每 10000 人中有 10.9 例（95%CI，1.9-17.4 例）缺血性中风、14.8 例（95%CI，7.9-21.8 例）心肌梗死、11.3 例（95%CI，3.4-17.7 例）其他血栓栓塞事件和 17.1 例（95%CI，8.8-30.2 例）肾损伤。这些估计在年龄（<40、40-69 和≥70 岁）和种族（黑人、白人）定义的亚组中基本相似，但在老年人和白人中缺血性中风的风险差异较大，在老年人中肾损伤的风险较高，在黑人中其他血栓栓塞事件的风险较高。在第一剂后 42 天内，两种疫苗之间存在较小的风险差异，在第一剂后 14 天内差异较小。
这项队列研究的结果表明，在第一剂后 14 天内，两种疫苗的不良事件风险差异较小，第一剂后 42 天内的风险差异较小。两组疫苗的 38 周不良事件风险较低，尽管 mRNA-1273 疫苗接种者的风险低于 BNT162b2 疫苗接种者。虽然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归因于 BNT162b2 疫苗预防 SARS-CoV-2 感染后遗症的有效性低于 mRNA-1273 疫苗的可能性。这些发现可能有助于为未来的疫苗接种活动提供决策依据。
