ASSESSMENT AND ANALYSIS OF ADVERSE EVENTS FOLLOWING COVID-19 VACCINATION AMONG CHILDREN AGED 15-18 Y AT TERTIARY CARE TEACHING HOSPITAL, TELANGANA: A PROSPECTIVE OBSERVATIONAL STUDY

SWARUPA RANI KASUKURTHI; CHAKRADHAR T.; SRAVANI MARPAKA; N. KARUNASREE

doi:10.22159/ijpps.2023v15i3.47358

Authors

SWARUPA RANI KASUKURTHI Department of Pharmacology, Osmania Medical College, Koti, Hyderabad, Telangana, India 500095 https://orcid.org/0000-0002-5337-6488
CHAKRADHAR T. Department of Pharmacology, Osmania medical College, Koti, Telangana, India 500095 https://orcid.org/0000-0002-3211-2854
SRAVANI MARPAKA Adverse Drug Reaction Monitoring Centre-Osmania Medical College, Koti, Hyderabad, Telangana, India-500095 https://orcid.org/0000-0003-2523-8704
N. KARUNASREE Department of Pharmacology, Osmania Medical College, Koti, Hyderabad, Telangana, India 500095

DOI:

https://doi.org/10.22159/ijpps.2023v15i3.47358

Keywords:

Covid 19, Covaxin, Adolescents

Abstract

Objective: Government of India (GOI) has allowed vaccination for age group of 15-18 y. It is a positive step toward boosting immunization rates across the nation. As per guidelines, BBV152 vaccine, Bharat Biotech's “Covaxin” is approved for adolescents. The study was designed to evaluate adverse events following immunization (AEFI) among adolescents.

Methods: A prospective, observational survey was carried out among the first 315 beneficiaries (adolescents of age 15-18 y) for a period of 5 mo at Osmania medical college and hospitals. Within 24 h, 48-72 h, and two weeks following the first and second doses of Covaxin, active and passive surveillance using telephonic inquiry and documentation relating to adverse events was conducted. The prevalence of AEFI and its association with demographic factors have been identified. Collected data were analyzed using SPSS 25.

Results: The first 315 beneficiaries (Adolescents between the ages of 15 and 18) who received Covaxin were identified. All AEFIs reported were within the first 24-72 h of vaccination. AEFI incidence was higher in 1^st dose (16.6%) when compared to 2^nd dose (3.5%). No AEFIs were noted after 2 w. We found no association of AEFI with sex, age group, and past history of Covid as this finding is not significant (p>0.05).

Conclusion: Overall, Covaxin has a good safety profile in adolescents. Symptoms were transient and of low intensity. There were no documented severe and serious AEFI. It is obligatory for documentation as the AEFI profile will encourage vaccine adoption and lessen reluctance.

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References

Matta S, Chopra KK, Arora VK. Morbidity and mortality trends of covid 19 in top 10 countries. Indian J Tuberc. 2020 Dec;67(4S):S167-72. doi: 10.1016/j.ijtb.2020.09.031. PMID 33308665, PMC7543896.

Weekly epidemiological update on COVID-19-23; Nov 2022. Available from: https://www.who.int/publications/m/item/weekly epidemiological-update-on-covid-19-23 November 2022. [Last accessed on 25 Nov 2022]

ICMR: Indian Council of Medical Research. New Delhi; 2020. Available from: https://vaccine.icmr.org.in/index.php/website-policy. [Last accessed on 25 Nov 2022]

Fact sheet for vaccine recipients and caregivers; Jan 2021. Available from: https://www.bharatbiotech.com/images/covaxin/covaxin-factsheet.pdf. [Last accessed on 25 Nov 2022]

Srivastava RK, Ish P, Covid Vaccination Group S. The initial experience of COVID-19 vaccination from a tertiary care centre of India. Monaldi Arch Chest Dis. 2021 Mar 31;91(4). doi: 10.4081/monaldi.2021.1816, PMID 33794595.

Nath R. Safety profile of COVID-19 vaccination among adolescents in India-an initial experience. EpidemInt 2020;07(2):13-6. doi: 10.24321/2455.7048.202208.

Vadrevu KM, Reddy S, Jogdand H, Ganneru B, Mirza N, Tripathy VN. Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study. Lancet Infect Dis. 2022 Sep;22(9):1303-12. doi: 10.1016/S1473-3099(22)00307-3. PMID 35717995, PMCID PMC9212880.

Mohfw GOI. Covaxin receives approval for emergency use in 12-18 y old children. Available from: https://www.mohfw.gov.in/pdf/GuidelinesforCOVID19VaccinationofChildrenbetween15to18yearsandPrecautionDosetoHCWsFLWsand60populationwithcomorbidities.pdf. [Last accessed on 25 Nov 2022]

Global manual on surveillance of adverse events following immunization; May 2016. Available from: https://www.who.int/publications/i/item/10665206144.WHO. [Last accessed on 25 Nov 2022].

MOHFW-GOI Universal Immunization Program (UIP) Revised AEFI guidelines: Executive summary. Available from: https://main.mohfw.gov.in/sites/default/files/Revised%20AEFI%20Guidelines%20Execute%20Summary.pdf. [Last accessed on 27 Nov 2022]

Frenck RW, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S. Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents. N Engl J Med. 2021 Jul 15;385(3):239-50. doi: 10.1056/NEJMoa2107456. PMID 34043894, PMCID PMC8174030.

Covaxin SMPC. Fact Sheet for Vaccine Recipient Approved for Restricted Use in Emergency by CDSCO. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/en/COVAXIN-SMPC_-BBIL.pdf and https://www.bharatbiotech.com/images/covaxin/covaxin-factsheet.pdf. [Last accessed on 27 Nov 2022]

Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomized, phase 1 trial. Lancet Infect Dis. 2021 May;21(5):637-46. doi: 10.1016/S1473-3099(20)30942-7. PMID 33485468, PMC7825810.

Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173-84. doi: 10.1016/S0140-6736(21)02000-6. PMID 34774196, PMCID PMC8584828.

Gupta S, Malhotra N, Gupta N, Agrawal S, Ish P. The curious case of coronavirus disease 2019 (COVID-19) in children. J Pediatr. 2020 Jul;222:258-9. doi: 10.1016/j.jpeds.2020.04.062. PMID 32360416, PMCID PMC7189853.

Parida SP, Sahu DP, Singh AK, Alekhya G, Subba SH, Mishra A. Adverse events following immunization of COVID‐19 (Covaxin) vaccine at a tertiary care center of India. J Med Virol. 2022;94(6):2453-9. doi: 10.1002/jmv.27655. PMID 35149993, PMCID PMC9088522.

Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID symptom study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939-49. doi: 10.1016/S1473-3099(21)00224-3. PMID 33930320, PMCID PMC8078878.

Kamal D, Thakur V, Nath N, Malhotra T, Gupta A, Batlish R. Adverse events following ChAdOx1 nCoV-19 Vaccine (COVISHIELD) amongst health care workers: a prospective observational study. Med J Armed Forces India. 2021;77(Suppl 2):S283-8. doi: 10.1016/j.mjafi.2021.06.014. PMID 34334895.

Dutta S, Kaur RJ, Charan J, Ambwani S, Besi PS, Odontology F. Serious adverse events reported from the COVID‐19 vaccines: a descriptive study based on WHO database. medRxiv Prepr Published online March 24; 2021. doi: 10.1101/2021.03.23.21253433.

Kaur U, Ojha B, Pathak BK, Singh A, Giri KR, Singh A. A prospective observational safety study on ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) use in healthcare workers-first results from India. E Clinical Medicine. 2021;38:101038. doi: 10.1016/j.eclinm.2021.101038. PMID 34505032.

Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S. Safety and immunogenicity of an inactivated SARS‐CoV‐2 vaccine, BBV152: interim results from a double‐blind, randomised, multicentre, phase 2 trial, and 3 mo follow-ups of a double‐blind, randomised phase 1 trial. Lancet Infect Dis. 2021;21(7):950-61. doi: 10.1016/S1473-3099(21)00070-0. PMID 33705727, PMC8221739.

Joshi RK, Muralidharan CG, Gulati DS, Mopagar V, Dev JK, Kuthe S. Higher incidence of reported adverse events following immunization (AEFI) after first dose of COVID-19 vaccine among previously infected health care workers. Med J Armed Forces India. 2021 Jul;77Suppl 2:S505-7. doi: 10.1016/j.mjafi.2021.05.011. PMID 34334920, PMC8313055.

Mathioudakis AG, Ghrew M, Ustianowski A, Ahmad S, Borrow R, Papavasileiou LP. Self-reported real-world safety and reactogenicity of COVID-19 vaccines: a vaccine recipient survey. Life (Basel). 2021 Mar 17;11(3):249. doi: 10.3390/life11030249, PMID 33803014, PMC8002738.

Iyengar KP, Singh B, Vaishya R, Jain VK, Ish P. Should COVID-19 vaccination be made mandatory? Lung India. 2021 Jul-Aug;38(4):379-81. doi: 10.4103/lungindia.lungindia_181_21. PMCID PMC8272417, PMID 34259181.

Kunal S, Aditi, Gupta K, Ish P. COVID-19 variants in India: potential role in second wave and impact on vaccination. Heart Lung. 2021;50(6):784-7. doi: 10.1016/j.hrtlng.2021.05.008. PMID 34217989.