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)

Abstract

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. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-022-00543-9.

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study

“…In further analysis of our data, we observed that local side effects were more common after MOD compared to BNT, however, only some systemic symptoms were significantly different between BNT and MOD. Previous studies reported a higher side effect rate after MOD compared to BNT [ 26 ]. Both vaccines are mRNA-based and are packed in lipid particles and contain no adjuvants.…”

Effectiveness and safety of immune response to SARS‑CoV‑2 vaccine in patients with chronic kidney disease and dialysis: A systematic review and meta‑analysis

“…In addition, when condition of patients with CKD is stable, COVID-19 vaccine is recommended. Studies have shown that the mRNA-1273 vaccine can induces higher antibody levels than the BNT162b2 vaccine, but the incidence of adverse events is also higher, requiring care in vaccine selection ( 84 , 85 ). Repeated doses of the COVID-19 vaccine improve the antibody levels and serum conversion rate of patients with kidney disease.…”

Association between Reactogenicity and Immunogenicity in a Vaccinated Cohort with Two mRNA SARS-CoV-2 Vaccines at a High-Complexity Reference Hospital: A Post Hoc Analysis on Immunology Aspects of a Prospective Cohort Study

“…This was an observational, unicentric study with real-world data (RWD) that was implemented as a post hoc subanalysis of the VigilVacCOVID study [ 17 ]. The population of the VigilVacCOVID study included HCPs vaccinated with BNT162b2 and mRNA-1273 vaccines and SOTRs vaccinated with mRNA-1273.…”

“…Reactogenicity and tolerability results had been previously obtained during the vaccination campaign in the context of the VigilVacCOVID study. The characteristics of the implemented surveillance program, the methodology of the safety data collection, and the overall reactogenicity profile assessed in the main VigilVacCOVID study are described elsewhere [ 17 ].…”

“…In our prior VigilVacCOVID study, we observed a correlation between reactogenicity and immunogenicity [ 17 ]. This was evidenced by the consistent association of a higher incidence of AR with younger age and prior exposure to SARS-CoV-2, which is also in line with other published reports [ 18 ].…”