Tolerability and Reactogenicity Profile of mRNA SARS-Cov-2 Vaccines from a Mass Vaccination Campaign in a Tertiary Hospital: Between-Vaccine and Between-Population Prospective Observational Study (VigilVacCOVID Study)

BioDrugs - Tập 36 - Trang 509-520 - 2022
Joaquín Sáez-Peñataro1, Ferran Torres1,2, Joan Bartra3,4,5, Juan Bascuas1, Anna Vilella6, Marta Tortajada7, Sebastiana Quesada7, Elisenda González6, Ester López-Suñé8, Antoni Castells9, Sandra Serrano2, Concepción Camacho10, Antoni Trilla6, Gonzalo Calvo1
1Medicine Division, Department of Clinical Pharmacology, Hospital Clinic, Barcelona, Spain
2IDIBAPS Biostatistics Core Facility, Medicine Division, Department of Clinical Pharmacology, Hospital Clinic, Barcelona, Spain
3Department of Pneumology, Allergy Section, Institut Clínic Respiratori (ICR), Hospital Clinic de Barcelona, Barcelona, Spain
4Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain
5Spanish Network for Allergy-RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain
6Department of Preventive Medicine and Epidemiology, Hospital Clinic, Barcelona, Spain
7Department of Occupational Health Care, Hospital Clinic, Barcelona, Spain
8Medicine Division, Department of Hospital Pharmacy, Hospital Clinic, Barcelona, Spain
9Chair of the Pharmacovigilance Technical Committee (PhVTC), Medical Director, Hospital Clinic of Barcelona, Barcelona, Spain
10Medicine Division, Hospital Clinic, Barcelona, Spain

Tóm tắt

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.

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