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Licensed Unlicensed Requires Authentication Published online by De Gruyter February 16, 2022

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

  • Mohammed Salim Karattuthodi EMAIL logo , Dilip Chandrasekher , Linu Mohan Panakkal , Shinu C , Mohammed Salman , Megha , Muhammad Swabeeh E , Mohamed Fasil , Mohammad A M and Monika Reji

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.


Corresponding author: Mohammed Salim Karattuthodi, Department of Pharmacy Practice, Al Shifa College of Pharmacy, Kizhattoor, 679325, Kerala, India, Phone: 00919656790871, E-mail:

  1. Research funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

  2. Author contribution: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: The authors declare no conflict of interest.

  4. Institution ethics committee approval: The research work had been verified and approved by the IEC stated by the reference letter No KAS:ADMN:IEC:61:21.

  5. Informed consent: Informed consent was obtained from all individuals included in this study.

  6. Ethical approval: The research work had been verified and approved by the IEC stated by the reference letter No KAS:ADMN:IEC:61:21

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Received: 2021-11-10
Revised: 2022-01-13
Accepted: 2022-01-26
Published Online: 2022-02-16

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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