Safety and Side Effect Profile of Inactivated Sars-Cov-2 Vaccine, BBIBP-Corv in Pakistani Population
DOI:
https://doi.org/10.51253/pafmj.v75iSUPPL-6.9629Keywords:
COVID 19; Safety; VaccineAbstract
Objective: To evaluate the short-term safety & side effect profile of inactivated SARS-CoV-2 vaccine, BBIBP-CorV in Pakistani population.
Study Design: Prospective longitudinal study
Place and Duration of Study: Combined Military Hospital, Malir Pakistan, from Feb 2021 to May 2021.
Methodology: In this study, a total of 5428 individuals aged between 18 to 60 years were vaccinated with 0.5ml of inactivated SARS-CoV-2 vaccine, BBIBP-CorV two doses each 21 days apart. The study participants were observed in vaccination center for 30 minutes post vaccination and then followed up for the next 5 days after each dose. Patients were observed for local & systemic side effects after the vaccine at the spot and on follow up.
Results: A total of 5428 individuals were vaccinated out of which 252(4.46%) experienced local side effects which include 236 (4.34%) with pain at injection site and 16(0.002%) individuals with local induration at site of injection. 258(4.75%) participants experienced systemic side effects which include 103(1.9%) individuals with nausea within 30 mins, 29(0.53%) individuals with fever in first 2 hours and 126(2.32%) individuals reported fatigue.
Conclusion: SinoPharm VeroCell vaccine has a relatively good safety profile as far as the short-term side effects are concerned. Most of the individuals who got vaccinated did not develop any side effects. Even those who did develop local or systemic adverse effects, they were mild and short lived.
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References
1. Ahmad S, Lucero-Prisno DE, Essar MY, Khan H, Ahmadi A. Pakistan and COVID-19: The mystery of the flattened curve. J Glob Health 2021; 11: 03013.
https://doi.org/10.7189/jogh.11.03013
2. Aburto JM, Kashyap R, Schöley J, Angus C, Ermisch J, Mills MC et al. Estimating the burden of the COVID-19 pandemic on mortality, life expectancy and lifespan inequality in England and Wales: A population-level analysis. Journal of Epidemiology and Community Health. 2021 janv. 1.
https://doi.org/10.1136/jech-2020-215505
3. Umair M, Ikram A, Salman M, Khurshid A, Alam M, Badar N et al. Whole-genome sequencing of SARS-CoV-2 reveals the detection of G614 variant in Pakistan. PLoS One 2021; 16(3): e0248371. https://doi.org/10.1371/journal.pone.0248371
4. Tregoning, J.S., Brown, E.S., Cheeseman, H.M., Flight, K.E., Higham, S.L., Lemm, N.-M., Pierce, B.F., Stirling, D.C., Wang, Z. and Pollock, K.M. (2020), Vaccines for COVID-19. Clin. Exp. Immunol 202: 162-192. https://doi.org/10.1111/cei.13517
5. Perdue, Samuel Scott and Humphrey, John H.. "Immune system". Encyclopedia Britannica, 20 Aug. 2020, https://www.britannica.com/science/immune-system
6. Orenstein WA, Ahmed R. Simply put: Vaccination saves lives. Proc Natl Acad Sci U S A 2017; 114(16): 4031-4033.
https://doi.org/10.1073/pnas.1704507114
7. Heinz FX, Stiasny K. Profiles of current COVID-19 vaccines. Wien Klin Wochenschr 202; 133(7-8): 271-283.
https://doi.org/10.1007/s00508-021-01835-w
8. Pullan S, Dey M. Vaccine hesitancy and anti-vaccination in the time of COVID-19: A Google Trends analysis. Vaccine 2021; 39(14): 1877-1881. https://doi.org/10.1016/j.vaccine.2021.03.019
9. Torjesen I. Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination. BMJ 2021; 372: n149.
https://doi.org/10.1136/bmj.n149
10. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. https://doi.org/10.1016/S1473-3099(20)30831-8
11. Niesen MJM, Pawlowski C, O'Horo JC, Challener DW, Silvert E, Donadio G et al. Surveillance of Safety of 3 Doses of COVID-19 mRNA Vaccination Using Electronic Health Records. JAMA Netw Open 2022; 5(4): e227038.
https://doi.org/10.1001/jamanetworkopen.2022.7038
12. Haralambieva IH, Salk HM, Lambert ND, Ovsyannikova IG, Kennedy RB, Warner ND et al. Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine 2014; 32(17): 1946-53.
https://doi.org/10.1016/j.vaccine.2014.01.090
13. Hsu LC, Lin SR, Hsu HM, Chao WH, Hsieh JT, Wang MC et al. Ethnic differences in immune responses to hepatitis B vaccine. Am J Epidemiol 1996; 143(7): 718-24.
https://doi.org/10.1093/oxfordjournals.aje.a008805
14. Shimabukuro T, Nair N. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine. JAMA 2021; 325(8): 780–781.
https://doi.org/10.1001/jama.2021.0600
15. Leung, J., Siegel, S., Jones, J. F., Schulte, C., Blog, D., Schmid, D. S et al. (2014). Fatal varicella due to the vaccine-strain varicella-zoster virus. Human vaccines & immunotherapeutics, 10(1), 146–149. https://doi.org/10.4161/hv.26200
16. Committee to Review Adverse Effects of Vaccines; Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Stratton K, Ford A, Rusch E, Clayton EW, editors. Washington (DC): National Academies Press (US); 2011 Aug 25. PMID: 24624471.
17. Ammirati E, Cavalotti C, Milazzo A, Pedrotti P, Soriano F, Schroeder JW et al.Temporal relation between second dose BNT162b2 mRNA Covid-19 vaccine and cardiac involvement in a patient with previous SARS-COV-2 infection. Int J Cardiol Heart Vasc 2021; 34:100774.
https://doi.org/10.1016/j.ijcha.2021.100774
18. BMJ 2021;373:n1046 http://dx.doi.org/10.1136/bmj.n1046 Published: 21 April 2021.
19. Long B, Bridwell R, Gottlieb M. Thrombosis with thrombocytopenia syndrome associated with COVID-19 vaccines. Am J Emerg Med 2021; 49: 58-61.
https://doi.org/10.1016/j.ajem.2021.05.054
20. Huang J, Du J, Duan R, Zhang X, Tao C, Chen Y et al. Characterization of the Differential Adverse Event Rates by Race/Ethnicity Groups for HPV Vaccine by Integrating Data From Different Sources. Front Pharmacol 2018; 9:539.
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