Pharmacist-directed Sputnik V (GAM-COVID-VAC) surveillance program: a prospective observational study in Southern India.

Abstract

Objectives: The study underwent to evaluate the adverse events, the incidence of COVID-19 and the participant's attitude and perception towards the vaccine following Sputnik V administration through an active surveillance program.

Methods: The prospective observational study was conducted four months in the Sputnik V vaccination center that enrolled 700 participants. Sociodemographic details, medical histories, COVID-19 incidences and adverse events following immunization (AEFI) of each sample were collected through face-to-face interviews and a telephonic feedback system. A self-prepared and validated questionnaire addressed their acceptances and perceptions towards the vaccination drive.

Results: Our study reported 42.1% of AEFIs after the first dose and 9.1% after the second. Fever, pain at the injection site, body pain, headache and fatigue were predominant, while dizziness and diarrhoea were rare. However, AEFIs were not influenced by the presence of comorbidities (p > 0.05). On the other hand, there were limited post immunization (1.8%) COVID-19 patients and that too with minor severity (p < 0.01). Our participants were overall satisfied with the Sputnik V immunization. However, those presented with AEFIs on the consecutive three days depicted slightly declined gratification (p < 0.05).

Conclusions: Our pharmacist-directed surveillance program on Sputnik V showed fewer events of AEFIs and negligible occurrence of COVID19 following immunization. Moreover, the population had appreciable attitude and positive perceptions towards Sputnik V vaccination.