Medicine Division, Department of Clinical Pharmacology, Hospital Clinic, Carrer Villarroel, 170, 08036, Barcelona, Spain.
IDIBAPS Biostatistics Core Facility, Medicine Division, Department of Clinical Pharmacology, Hospital Clinic, Barcelona, Spain.
BioDrugs. 2022 Jul;36(4):509-520. doi: 10.1007/s40259-022-00543-9. Epub 2022 Jun 28.
The comparative safety profile of SARS-Cov2 vaccines requires further characterization in real-world settings.
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.
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.
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.
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.
SARS-CoV-2 疫苗的比较安全性概况需要在真实环境中进一步描述。
VigilVacCOVID 研究的目的是评估在医院诊所进行医护人员（HCPs）和实体器官移植受者（SOTRs）疫苗接种期间，BNT162b2 和 mRNA-1273 的短期安全性。
我们进行了一项观察性、前瞻性、单中心、上市后研究，以描述接种疫苗后的短期不良反应（ARs）。主要终点是评估疫苗之间（接受 BNT162b2 或 mRNA-1273 的 HCPs）和人群之间（均接受 mRNA-1273 的 HCPs 和 SOTRs）任何 AR 风险的差异。使用倾向评分和协变量调整的多变量模型。关键次要终点是提供 AR 频率和强度分布的描述性评估。
我们纳入了 5088 名 HCPs 和 1289 名患者。mRNA-1273 的反应原性大于 BNT162b2，任何 AR 的比值比（OR）为 3.04（95%置信区间（CI）2.48-3.73；p 值：<0.001），且报告的 AR 频率和强度更高。与接受 mRNA-1273 疫苗接种的 HCPs 相比，SOTRs 的 AR 风险较低（OR=0.36；95%CI 0.25-0.50），AR 较少且较轻。年龄、性别和既往 SARS-CoV-2 感染是任何 AR 风险的统计学显著协变量。药物过敏史在疫苗之间的比较（BNT162b2 与 mRNA-1273）中具有统计学意义，但在 SOTRs 与 HCPs 之间的比较中没有意义。
我们的研究表明，mRNA-1273 的反应原性大于 BNT162b2。总体而言，两种疫苗均具有良好的耐受性。mRNA-1273 疫苗接种在 SOTRs 中引起的 AR 较少，严重程度较轻。
