Safety of BNT162b2 mRNA COVID-19 Vaccine Batches: A Nationwide Cohort Study.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-09-01 DOI:10.1002/pds.70207

Anders Hviid, Ingrid Bech Svalgaard

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Abstract

Objectives: The safety of the BNT162b2 mRNA COVID-19 vaccine has been extensively evaluated since the global rollout began. While serious adverse events are rare, safety issues continue to arise. This study evaluates the claim that earlier small vaccine batches were associated with higher rates of serious adverse events compared to later batches.

Design, participants, setting: A nationwide cohort study was conducted in Denmark, comprising individuals vaccinated with the BNT162b2 vaccine from 52 pre-defined batches classified into three pre-defined groups. Vaccinated individuals were matched 1:1 between batch groups on age, sex, and vaccination priority group. The study outcomes included 27 serious adverse events, two negative control outcomes, and all-cause mortality. Cox regression was used to estimate hazard ratios (HRs) comparing rates between batch groups in the 28 days following vaccination. We conducted two comparisons of the early small batches to two groups of larger batches used later in the pandemic.

Results: In the study period, 9 983 728 vaccinations were administered from batches in the three pre-defined groups. Slightly increased rates of arrhythmia were observed in both study comparisons, HRs 1.25 (95% CI, 1.05-1.50) and 1.15 (1.00-1.31), respectively, but sensitivity analyses did not robustly support these associations. For the remaining outcomes, increased rates in both study comparisons were not observed.

Conclusion: This nationwide cohort study provides reassurance regarding the safety of the BNT162b2 vaccine across different batches used in Denmark. The findings support the overall safety of the vaccine, with no clinically relevant variations in serious adverse event rates between batches.

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BNT162b2 mRNA新冠病毒疫苗批次的安全性：一项全国队列研究

目的：自全球推广以来，BNT162b2 mRNA COVID-19疫苗的安全性已得到广泛评估。虽然严重的不良事件很少发生，但安全问题不断出现。本研究评估了较早的小批次疫苗与较晚批次疫苗相比，严重不良事件发生率较高的说法。设计，参与者，环境：在丹麦进行了一项全国性队列研究，包括从52个预先确定的批次中接种了BNT162b2疫苗的个体，分为三个预先确定的组。接种个体按年龄、性别和接种优先组在批组之间按1:1匹配。研究结果包括27例严重不良事件，2例阴性对照结果和全因死亡率。采用Cox回归估计接种后28天批次组间的风险比（hr）比较率。我们对早期小批次与大流行后期使用的两组较大批次进行了两次比较。结果：在研究期间，三个预先确定的组中分批次接种了9983 728次疫苗。两项研究比较均观察到心律失常发生率略有增加，hr分别为1.25 （95% CI, 1.05-1.50）和1.15(1.00-1.31)，但敏感性分析并未有力支持这些关联。对于其余的结果，没有观察到两项研究比较中发生率的增加。结论：这项全国性队列研究为丹麦不同批次使用的BNT162b2疫苗的安全性提供了保证。研究结果支持疫苗的总体安全性，批次之间的严重不良事件发生率没有临床相关差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.