Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson's Disease and Multiple Sclerosis: A Longitudinal Study

Abstract

The Republic of San Marino COVID-19 vaccination campaign used Gam-COVID-Vac and Pfizer-BioNTech vaccines. To assess adverse events following immunization (AEFIs), approximately 6000 vaccine recipients were monitored by the ROCCA study, including subgroups with Parkinson's Disease (PD) and Multiple Sclerosis (MS). The purpose of this study is to evaluate short-term AEFIs through a 1-month follow-up. We conducted a longitudinal study, using active surveillance to evaluate the safety profiles of COVID-19 vaccines in PD and MS patients. Participants were actively administered a standardized online questionnaire to collect information on AEFIs. Among all PD and MS assisted by the San Marino hospital, a total of 82 patients completed the questionnaires. One week after administration of the first dose, vaccine recipients reported AEFIs in 26% of cases in the PD group, 67% in the MS group, and 68% in the control group. Participants reported slightly higher rates of AEFIs after dose 2 compared with dose 1, being 29%, 75%, and 78% for PD, MS, control group, respectively. Most of the reported symptoms were mild. Patients with PD and MS reported few AEFIs after administration of the COVID-19 vaccines. The frequency of AEFIs in the PD population was significantly lower than in the control group.

Keywords: AEFI; Gam-COVID-Vac; Multiple Sclerosis; Parkinson’s disease; Pfizer-BioNTech; adverse event; vaccination.