Background

The comparative safety profile of SARS-Cov2 vaccines requires further characterization in real-world settings.

Objectives

The aim of the VigilVacCOVID study was to assess the short-term safety of BNT162b2 and mRNA-1273 during the vaccination campaign of healthcare professionals (HCPs) and solid-organ transplant recipients (SOTRs) at a hospital clinic.

Methods

We conducted an observational, prospective, single-center, post-authorization study to characterize short-term adverse reactions (ARs) after vaccination. The primary endpoint was to assess between-vaccine differences (HCPs receiving BNT162b2 or mRNA-1273) and between-population differences (HCPs and SOTRs, both receiving mRNA-1273) in the risk of any ARs. Propensity score and covariate-adjusted multivariate models were used. The key secondary endpoint was to provide a descriptive assessment of the frequencies and intensity distribution of ARs.

Results

We included 5088 HCPs and 1289 patients. mRNA-1273 showed greater reactogenicity than BNT162b2, with an odds ratio (OR) for any AR of 3.04 (95% confidence interval (CI) 2.48–3.73; p value: < 0.001) and a higher frequency and intensity of reported ARs. Compared with HCPs vaccinated with mRNA-1273, SOTRs showed a lower risk of ARs (OR = 0.36; 95% CI 0.25–0.50), with fewer and less severe ARs. Age, sex, and previous SARS-CoV-2 infection were statistically significant covariates for the risk of any AR. A history of drug allergy was significant in the comparison between vaccines (BNT162b2 vs. mRNA-1273), but not in that between SOTRs and HCPs.

Conclusions

Our study shows that mRNA-1273 had greater reactogenicity than BNT162b2. Overall, both vaccines had an adequate tolerability profile. mRNA-1273 vaccination caused fewer ARs with milder severity in SOTRs.

中文翻译：

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三级医院大规模疫苗接种运动中 mRNA SARS-Cov-2 疫苗的耐受性和反应原性：疫苗间和人群间前瞻性观察研究（VigilVacCOVID 研究）

背景

SARS-Cov2 疫苗的比较安全性需要在现实环境中进一步表征。

目标

VigilVacCOVID 研究的目的是评估 BNT162b2 和 mRNA-1273 在医院诊所的医疗保健专业人员 (HCP) 和实体器官移植受者 (SOTR) 的疫苗接种活动中的短期安全性。

方法

我们进行了一项观察性、前瞻性、单中心、授权后研究，以描述疫苗接种后的短期不良反应 (AR)。主要终点是评估任何 AR 风险的疫苗间差异（接受 BNT162b2 或 mRNA-1273 的 HCP）和人群间差异（HCP 和 SOTR，均接受 mRNA-1273）。使用倾向评分和协变量调整的多变量模型。关键的次要终点是对 AR 的频率和强度分布进行描述性评估。

结果

我们纳入了 5088 名 HCP 和 1289 名患者。mRNA-1273 表现出比 BNT162b2 更高的反应原性，任何 AR 的优势比 (OR) 为 3.04（95% 置信区间 (CI) 2.48-3.73；p值：< 0.001），报告的 AR 频率和强度更高。与接种 mRNA-1273 的 HCP 相比，SOTR 的 AR 风险较低（OR = 0.36；95% CI 0.25-0.50），AR 越来越少。年龄、性别和以前的 SARS-CoV-2 感染是任何 AR 风险的具有统计学意义的协变量。药物过敏史在疫苗之间（BNT162b2 与 mRNA-1273）的比较中很重要，但在 SOTR 和 HCP 之间的比较中没有。

结论

我们的研究表明，mRNA-1273 的反应原性高于 BNT162b2。总体而言，两种疫苗都具有足够的耐受性。mRNA-1273 疫苗接种在 SOTR 中引起的 AR 较少，严重程度较轻。