Pharmacist-directed Sputnik V (GAM-COVID-VAC) surveillance program: a prospective observational study in Southern India
-
Mohammed Salim Karattuthodi
,
Dilip Chandrasekher
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.
-
Research funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
-
Author contribution: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: The authors declare no conflict of interest.
-
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.
-
Informed consent: Informed consent was obtained from all individuals included in this study.
-
Ethical approval: The research work had been verified and approved by the IEC stated by the reference letter No KAS:ADMN:IEC:61:21
References
1. Department of Pharmacology, Government Medical College, Gondia, Maharashtra, India, Jaiswal KM, Dudhgaonkar S, Department of Pharmacology, Government Medical College, Gondia, Maharashtra, India, Raghute L, Department of Pharmacology, Government Medical College, Gondia, Maharashtra, India, et al.. An assessment of AEFI COVID-19 vaccination in health care workers at a tertiary health care centre in central India. Microbiol Res Int. 2021;9:46–50.Suche in Google Scholar
2. Kunal, S, Sakthivel, P, Gupta, N, Ish, P. Mix and match COVID-19 vaccines: potential benefit and perspective from India. Postgrad Med 2021. https://doi.org/10.1136/postgradmedj-2021-140648.Suche in Google Scholar PubMed
3. Kim, M-A, Lee, YW, Kim, SR, Kim, J-H, Min, T k, Park, H-S, et al.. COVID-19 vaccine-associated anaphylaxis and allergic reactions: consensus statements of the KAAACI urticaria/angioedema/anaphylaxis working group. Allergy Asthma Immunol Res. 2021;13:526–44, https://doi.org/10.4168/aair.2021.13.4.526.Suche in Google Scholar PubMed PubMed Central
4. Siddique, S, Ahmed, S. COVID-19 vaccines in Pakistan: efficacy, adverse effects and availability. J Islamabad Med Dent College. 2021;10:125–30, https://doi.org/10.35787/jimdc.v10i2.723.Suche in Google Scholar
5. Ahmad, S, Singh, S, Wasim, S, Rai, S. Adverse event following immunization (AEFI) and COVID-19 vaccination: a review. Int J Curr Microbiol Appl Sci. 2021;10:555–65.10.20546/ijcmas.2021.1006.061Suche in Google Scholar
6. Hasan, T, Beardsley, J, Marais, BJ, Nguyen, TA, Fox, GJ. The implementation of mass-vaccination against SARS-CoV-2: a systematic review of existing strategies and guidelines. Vaccines. 2021;9:326, https://doi.org/10.3390/vaccines9040326.Suche in Google Scholar PubMed PubMed Central
7. Leghari, Q, Chand, SK, Bushra, R, Rizvi, M, Khan, M, Shahnaz, S, et al.. Exploration of perception, need and barriers against pharmacovigilance and adverse drug reactions reporting: healthcare professionals’ insight. J Pharm Res Int 2021;33:78–86. https://doi.org/10.9734/jpri/2021/v33i731204.Suche in Google Scholar
8. World Medical Association. World Medical Association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4, https://doi.org/10.1001/jama.2013.281053.Suche in Google Scholar PubMed
9. National Health Authority. CoWIN [Online]. Available from: https://www.cowin.gov.in/ [cited 2021 Nov 9].Suche in Google Scholar
10. National Health Authority. Aarogya Setu [Online]. Available from: https://aarogyasetu.gov.in/ [cited 2021 Nov 9].Suche in Google Scholar
11. Chauhan, S Pharmacovigilance-A drug safety monitoring tool. J Pharmacovigil Drug Res. 2021;2:15–20, https://doi.org/10.53411/jpadr.2021.2.3.4.Suche in Google Scholar
12. World Health Organisation. Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification, 2nd ed., Geneva: World Health Organisation; 2019 [Online]. Available from: https://www.who.int/publications-detail-redirect/causality-assessment-aefi-user-manual-2019 [cited 2021 Nov 9].Suche in Google Scholar
13. Montalti, M, Soldà, G, Di Valerio, Z, Salussolia, A, Lenzi, J, Forcellini, M, et al.. ROCCA observational study: early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance. EClinicalMedicine. 2021;38:101027, https://doi.org/10.1016/j.eclinm.2021.101027.Suche in Google Scholar PubMed PubMed Central
14. Novelli, G, Colona, VL, Pandolfi, PP. A focus on the spread of the delta variant of SARS-CoV-2 in India. Indian J Med Res. 2021;153:537–41, https://doi.org/10.4103/ijmr.ijmr_1353_21.Suche in Google Scholar PubMed PubMed Central
15. Lustig, Y, Zuckerman, N, Nemet, I, Atari, N, Kliker, L, Regev-Yochay, G, et al.. Neutralising capacity against Delta (B.1.617.2) and other variants of concern following Comirnaty (BNT162b2, BioNTech/Pfizer) vaccination in health care workers, Israel. Eurosurveillance. 2021;26:2100557, https://doi.org/10.2807/1560-7917.es.2021.26.26.2100557.Suche in Google Scholar PubMed PubMed Central
16. Parums, DV. Editorial: revised World Health Organization (WHO) terminology for variants of concern and variants of interest of SARS-CoV-2. Med Sci Monit. 2021;27:e933622-1–e933622-2, https://doi.org/10.12659/MSM.933622.Suche in Google Scholar PubMed PubMed Central
17. Singh, UB, Rophina, M, Chaudhry, R, Senthivel, V, Bala, K, Bhoyar, RC, et al.. Variants of concern responsible for SARS-CoV-2 vaccine breakthrough infections from India. J Med Virol [Online]; 1-5. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.27461 [cited 2022 Jan 12].10.31219/osf.io/fgd4xSuche in Google Scholar
18. Logunov, DY, Dolzhikova, IV, Shcheblyakov, DV, Tukhvatulin, AI, Zubkova, OV, Dzharullaeva, AS, et al.. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021;397:671–81, https://doi.org/10.1016/s0140-6736(21)00234-8.Suche in Google Scholar PubMed PubMed Central
19. Cazzola, M, Rogliani, P, Mazzeo, F, Matera, MG. Controversy surrounding the Sputnik V vaccine. Respir Med. 2021;187:106569, https://doi.org/10.1016/j.rmed.2021.106569.Suche in Google Scholar PubMed PubMed Central
20. Deming, ME, Lyke, KE. A ‘mix and match’ approach to SARS-CoV-2 vaccination. Nat Med. 2021;27:1510–1, https://doi.org/10.1038/s41591-021-01463-x.Suche in Google Scholar PubMed
21. Jaiswal, KM, Dudhgaonkar, S, Raghute, L, Uike, P, Kohli, S, Anand, I. An assessment of AEFI COVID-19 vaccination in health care workers at a tertiary health care centre in central India.Microbio. Res Int 2021;9:46–50.10.30918/MRI.92.21.017Suche in Google Scholar
22. Zimmermann, P, Curtis, N. Factors that influence the immune response to vaccination. Clin Microbiol Rev 2019;32. https://doi.org/10.1128/cmr.00084-18.Suche in Google Scholar
23. Kuntal, B, Lakshmi, GN, Deepshikha, M, Shashivadhanan, S. Patterns of antibody response, adverse effects, and knowledge regarding COVID-19 vaccine: findings of a serosurvey among vaccinated individuals in north-western India. 2001 [Online]. Available from: https://www.marinemedicalsociety.in/preprintarticle.asp?id=326739 [cited 2021 Oct 25].Suche in Google Scholar
24. Johansson, MA, Quandelacy, TM, Kada, S, Prasad, PV, Steele, M, Brooks, JT, et al.. SARS-CoV-2 transmission from people without COVID-19 symptoms. JAMA Netw Open. 2021;4:e2035057, https://doi.org/10.1001/jamanetworkopen.2020.35057.Suche in Google Scholar PubMed PubMed Central
25. Hawlader, MDH, Rahman, ML, Nazir, A, Ara, T, Akiful Haque, MM, Saha, S, et al.. Belief, attitude, and intention to take COVID-19 vaccine among South asian population: a multi-country study. Int J Infect Dis. 2021 [Online];114: 1-10 . Available from: https://www.sciencedirect.com/science/article/pii/S1201971221007591 [cited 2021 Oct 23].Suche in Google Scholar
26. Berihun, G, Walle, Z, Berhanu, L, Teshome, D. Acceptance of COVID-19 vaccine and determinant factors among patients with chronic disease visiting dessie comprehensive specialized hospital, northeastern Ethiopia. Patient Prefer Adherence. 2021;15:1795–805, https://doi.org/10.2147/ppa.s324564.Suche in Google Scholar PubMed PubMed Central
27. Pagotto, V, Ferloni, A, Soriano, MM, Díaz, M, Golde, MB, González, MI, et al.. Active surveillance of the Sputnik V vaccine in health workers. 2021. [Online]. Available from: https://www.medrxiv.org/content/10.1101/2021.02.03.21251071v1 [cited 2021 Oct 23] p. 2021.02.03.21251071.Suche in Google Scholar
28. Babamahmoodi, F, Saeedi, M, Alizadeh-Navaei, R, Hedayatizadeh-Omran, A, Mousavi, SA, Ovaise, G, et al.. Side effects and immunogenicity following administration of the Sputnik V COVID-19 vaccine among health care workers; an observational study in Iran. 2021. [Online]. Available from: https://www.researchsquare.com/article/rs-709499/v1 [cited 2021 Oct 23].10.1038/s41598-021-00963-7Suche in Google Scholar PubMed PubMed Central
29. Andrzej, J, Alexander, S, Mikołaj, K, Vitaly, B. Mild adverse events of Sputnik V vaccine extracted from Russian language Telegram posts via BERT deep learning model | medRxiv. [Online]. Available from: https://www.medrxiv.org/content/10.1101/2021.06.14.21258875v1 [cited 2021 Oct 26].Suche in Google Scholar
30. Rela, M, Jothimani, D, Vij, M, Rajakumar, A, Rammohan, A. Auto-immune hepatitis following COVID vaccination. J Autoimmun. 2021;123:102688, https://doi.org/10.1016/j.jaut.2021.102688.Suche in Google Scholar PubMed
31. Remlabeevi, A, Mathew, T, Nair, GSH, Nair, GLR, Alex, MR. Adverse events and their association with comorbidities after first and second doses of Covishield vaccination among healthcare workers of Government owned medical colleges in Kerala. 2021. [Online]. Available from: https://www.medrxiv.org/content/10.1101/2021.05.19.21257317v1 [cited 2021 Oct 25] p. 2021.05.19.21257317.10.1101/2021.05.19.21257317Suche in Google Scholar
© 2022 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Minireview
- Impact of mental toughness on athlete’s performance and interventions to improve
- Reviews
- A review of the mechanisms of anti-cancer activities of some medicinal plants–biochemical perspectives
- Antimicrobials in COVID-19: strategies for treating a COVID-19 pandemic
- Anxiolytic effects of vestibular stimulation: an update
- Original Articles
- Intermittent exposure to green and white light-at-night activates hepatic glycogenolytic and gluconeogenetic activities in male Wistar rats
- Study of pre-operative neutrophil–lymphocyte ratio in urothelial carcinoma
- The effects of Berberis vulgaris L. root extract on the opiate withdrawal syndrome and psychological factors: a randomized double-blind clinical trial
- Evidence of alterations in the learning and memory in offspring of stress-induced male rats
- The impact of vestibular symptoms and electronystagmography results on recovery from sudden sensorineural hearing loss
- Complementary mechanisms of modulation of spontaneous phasic contractions by the gaseous signalling molecules NO, H2S, HNO and the polysulfide Na2S3 in the rat colon
- Pharmacist-directed Sputnik V (GAM-COVID-VAC) surveillance program: a prospective observational study in Southern India
- Correlation among Poincare plot and traditional heart rate variability indices in adults with different risk levels of metabolic syndrome: a cross-sectional approach from Southern India
- Does etodolac affect TRPA1 functionality in vivo in human?
- Dynamic of irisin secretion change after moderate-intensity chronic physical exercise on obese female
- Letter to the Editor
- The prospective record-breaking obesity drug tirzepatide raises concerns about affordability
Artikel in diesem Heft
- Frontmatter
- Minireview
- Impact of mental toughness on athlete’s performance and interventions to improve
- Reviews
- A review of the mechanisms of anti-cancer activities of some medicinal plants–biochemical perspectives
- Antimicrobials in COVID-19: strategies for treating a COVID-19 pandemic
- Anxiolytic effects of vestibular stimulation: an update
- Original Articles
- Intermittent exposure to green and white light-at-night activates hepatic glycogenolytic and gluconeogenetic activities in male Wistar rats
- Study of pre-operative neutrophil–lymphocyte ratio in urothelial carcinoma
- The effects of Berberis vulgaris L. root extract on the opiate withdrawal syndrome and psychological factors: a randomized double-blind clinical trial
- Evidence of alterations in the learning and memory in offspring of stress-induced male rats
- The impact of vestibular symptoms and electronystagmography results on recovery from sudden sensorineural hearing loss
- Complementary mechanisms of modulation of spontaneous phasic contractions by the gaseous signalling molecules NO, H2S, HNO and the polysulfide Na2S3 in the rat colon
- Pharmacist-directed Sputnik V (GAM-COVID-VAC) surveillance program: a prospective observational study in Southern India
- Correlation among Poincare plot and traditional heart rate variability indices in adults with different risk levels of metabolic syndrome: a cross-sectional approach from Southern India
- Does etodolac affect TRPA1 functionality in vivo in human?
- Dynamic of irisin secretion change after moderate-intensity chronic physical exercise on obese female
- Letter to the Editor
- The prospective record-breaking obesity drug tirzepatide raises concerns about affordability
