Risk of adverse events after Omicron XBB-adapted BNT162b2 COVID-19 vaccination in the United States

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-01-25 DOI:10.1016/j.vaccine.2024.126629

Jenny W. Sun , Laura E. Dodge , Eric J. Kim , Li Zhou , Susan Mather , Henry Goebe , Nicola Charpentier , Kirsten Nespithal , Kofi Asomaning , Florence T. Wang

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引用次数: 0

Abstract

Background

Limited data exists regarding the safety of the COVID-19 2023–2024 vaccine formulations and whether the safety profiles differ from the original formulations. We evaluated the association between the BNT162b2 XBB COVID-19 vaccine and the risk of 20 pre-specified adverse events of special interest (AESIs).

Methods

We identified commercially-insured individuals in the US age ≥ 6 months who received the BNT162b2 XBB COVID-19 vaccine between September 11, 2023 and January 15, 2024 within the Optum pre-adjudicated database. The self-controlled risk interval design was used to compare the incidence of 20 pre-specified AESIs during a risk period following vaccination to a control period. Relative incidence and 95 % confidence intervals (CI) were estimated using exact conditional Poisson regression.

Results

The analysis included 113,459 individuals who received the BNT162b2 XBB COVID-19 vaccine (median [interquartile range] age: 47.1 [33.0–59.1] years). Relative incidence was calculated when ≥1 event occurred in either the risk or control period. For these 10 AESIs, there was no significant association between receipt of the BNT162b2 XBB COVID-19 vaccine and the incidence of any of these AESIs. Point estimates were higher in the risk period compared to the control period for ischemic stroke (relative incidence: 1.52; 95 % CI: 0.44–5.94), myocarditis/pericarditis (relative incidence: 1.50; 95 % CI: 0.22–12.61), immune-mediated myositis (relative incidence: 1.44; 95 % CI: 0.83–2.52), herpes zoster (relative incidence: 1.24; 95 % CI: 0.69–2.28), and non-febrile convulsions/seizures (relative incidence: 1.22; 95 % CI: 0.86–1.73). These estimates were not statistically significant, though most were based on few events. Results were generally similar in subgroup analyses of individuals administered a concomitant seasonal influenza vaccine.

Conclusions

There was no increased risk of 20 pre-specified AESIs following receipt of the BNT162b2 XBB COVID-19 vaccine among US commercially insured individuals aged ≥6 months. Findings are consistent with the current evidence on the safety of BNT162b2 COVID-19 vaccines.

Public registration: EUPAS108135.

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在美国，欧米克隆xbb适应型BNT162b2 COVID-19疫苗接种后不良事件的风险

背景：关于COVID-19 2023-2024疫苗配方的安全性以及安全性是否与原始配方不同的数据有限。我们评估了BNT162b2 XBB COVID-19疫苗与20个预先指定的特殊关注不良事件（AESIs）风险之间的关联。方法：我们在Optum预裁定数据库中筛选年龄≥6个月的美国商业保险个体，这些个体在2023年9月11日至2024年1月15日期间接种了BNT162b2 XBB COVID-19疫苗。采用自我控制风险区间设计，比较接种疫苗后风险期和对照期20例预先指定的AESIs的发病率。使用精确条件泊松回归估计相对发生率和95%置信区间（CI）。结果：分析纳入了113,459例接受BNT162b2 XBB COVID-19疫苗的个体（年龄中位数[四分位数间距]:47.1[33.0-59.1]岁）。当风险期或对照期发生≥1个事件时计算相对发生率。对于这10例AESIs，接种BNT162b2 XBB COVID-19疫苗与任何这些AESIs的发生率之间没有显着关联。缺血性卒中风险期的点估计值高于对照期(相对发病率：1.52；95% CI: 0.44-5.94)，心肌炎/心包炎(相对发病率：1.50；95% CI: 0.22-12.61)，免疫介导的肌炎(相对发病率：1.44；95% CI: 0.83-2.52)，带状疱疹(相对发病率：1.24；95% CI: 0.69-2.28)和非发热性惊厥/癫痫发作(相对发生率：1.22；95% ci: 0.86-1.73)。这些估计在统计上并不显著，尽管大多数是基于少数事件。同时接种季节性流感疫苗的个体亚组分析结果大致相似。结论：在年龄≥6个月的美国商业参保个体中，接种BNT162b2 XBB COVID-19疫苗后，20例预先指定的AESIs风险未增加。研究结果与目前关于BNT162b2 COVID-19疫苗安全性的证据一致。公共注册：EUPAS108135。

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

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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