ABSTRACT
INTRODUCTION: Few data are available on adverse events (AE) associated to vaccines in persons with multiple sclerosis (pwMS). AIMS: to study the incidence of acute phase AE (AP-AE) related to SARS-CoV-2 mRNA vaccines in pwMS compared to a control group, and to analyze the association between AP-AE and disease modifying treatments (DMT). METHODS: This was a cross-sectional study on 438 PwMS and 481 age- and sex-matched subjects not affected by dysimmune diseases that underwent two doses of SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer/BioNtech). RESULTS: Two hundred and twenty five (51.4%) pwMS complained of ≥1 AP-AE after the first dose, 269 (61.4%) after the second dose. A logistic regression analysis revealed that only pwMS on Fingolimod and Ocrelizumab did not show a higher risk of developing AP-AE. The likelihood to present with ≥1 AP-AE, after correcting for age and sex, was significantly higher in pwMS than controls. CONCLUSIONS: This study reports qualitative and quantitative features of AP-AE associated with the first and second doses of SARS-CoV-2 vaccine in a large sample of pwMS. The only risk factor identified for developing AP-AE is female gender. AntiCD-20 monoclonal antibodies and S1P inhibitors are associated with a lower risk of AP-AE occurrence.
ABSTRACT
Objective: A prospective observational study aimed at monitoring adverse drug reactions (ADR) in healthcare workers after a SARS-CoV-2 vaccination campaign was started in January 2021. We report preliminary results obtained from the pilot study. Methods: The first 300 Sars-CoV-2 vaccinated subjects (2 Comirnaty® (BioNTech, Pfizer) doses administrated 21 days apart) that signed informed consent were enrolled in the pilot study. For each patient, age, sex, body-mass-index (BMI), ADRs after vaccination and SARS-Cov-2-antibodies titer (quantitative evaluation of the neutralizing S1-RBD-IgG using Anti-SARS-CoV-2 QuantiVac ELISA (IgG)® Euroimmun diagnostic assay) were collected. The evaluation of SARS-Cov-2-antibodies was performed at the time of first dose administration (T0) and followed by four subsequent evaluations at different time-points. ADR developed within the first 8 days after the first and second dose were recorded. Exclusion criterion were cases with incomplete data. ADRs were divided into local (at injection site) and systemic, and their occurrence was correlated to sex, BMI and presence of SARS-Cov-2-IgG at T0. Fisher's exact test, Wilcoxon-Mann-Whitney test and multivariate logistic regression models were used for statistical analyses;p < 0.05 was considered significant. Results: In total 297 subjects (72.4% females;98.9% Caucasians, mean age 47 years) were included. Fifty (16.5%) subjects were positive for SARS-CoV-2-antibodies at T0. ADRs were reported in 67% and 74.1% of subjects after the first and second dose, respectively. Systemic ADRs were more common after the second dose (59.1% of subjects) compared to the first dose (31.4%). Systemic ADRs were reported in 44% of subjects positive for SARS-CoV-2 antibodies (22/50) and in only 28.9% of negative subjects (71/246) (p=0.044);this correlation was significant for fever (p=0.017) and lymphadenopathy (p=0.008). Systemic ADRs after the first dose occurred in 36.7% (79/215) of females and in 17.1% (14/82) of males (p=0.0012), while they occured in 63.7% (137/215) and 46.34% (38/82) after the second dose, respectively (p=0.0082). No correlation was found between ADR and BMI after both doses. Conclusion: These preliminary results demonstrate higher prevalence of systemic ADRs after a second dose and a positive correlation between female and ADRs after both the first and second doses. Moreover, there was a positive correlation between the presence of SARS-CoV-2-antibodies and systemic ADRs after the first dose. These data support the hypotheses that systemic reactions (fever, lymphadenopathy) could be a clinical expression of immune system reactivity to vaccination, which is greater in subjects with SARS-CoV-2-antibodies at the time of the first administration. These results will require confirmation from a greater sample size.