Comparison of the Onset and End of Specific and Major Side Effects in Iranian Teenage Participants Vaccinated With COVID-19 Vaccine: Sinopharm and Soberana

Overview

Journal Med J Islam Repub Iran

Specialty General Medicine

Date 2023 May 1

PMID 37123336

Authors

Nader Tavakoli

Nahid Nafissi

Sima Shokri

Morteza Fallahpour

Sanaz Soleimani

Taghi Riahi

Saeed Kalantari

Azadeh Goodarzi

Rohollah Valizadeh

Affiliations

Soon will be listed here.

Abstract

Background: Clinical trials were conducted on children on side effects after vaccination. We tried to assess the frequency and onset of the main symptoms in children who were vaccinated. We aimed to evaluate early and delayed adverse effects after coronavirus disease 2019 (COVID-19) vaccine among Iranian pediatrics and adolescents in a national survey.

Methods: This cross-sectional study included people <18 years who received the Soberana (PastoCoVac) and Sinopharm vaccines since 2021. The basic information was gender, age, type of vaccine, and reaction after vaccination besides the main events that occurred for them. The required data were collected via a predetermined checklist by trained interviewers through phone calls by their parents or legal guardians. The independent t test and Fisher exact test were used. P values less than 0.05 were considered significant.

Results: A total of 11,042 participants (age range, 10-18 years) consisting of 5374 boys (47.8%) and 5768 girls (52.2%) were studied and 88.1% of the children (n = 9727) were vaccinated by Sinopharm and 11.9% (n = 1315) by Soberana. The data of kidney-related side effects had delayed improvement of side effects after the Sinopharm compared with the Soberana vaccines ( = 0.012). Cardiovascular and hematological side effects showed early-onset ( = 0.006) and delayed improvement of side effects ( = 0.002) after the Soberana vaccine compared with the Sinopharm vaccine. Neurological side effects showed delayed improvement of side effects after the Soberana vaccine compared with the Sinopharm vaccine ( = 0.027). Joint-related side effects showed early-onset ( = 0.004) and delayed improvement of side effects ( = 0.023) after the Soberana vaccine compared with the Sinopharm vaccine. Respiratory side effects showed delayed improvement of side effects after the Soberana vaccine compared with the Sinopharm vaccine ( = 0.013), and dermatological side effects showed early-onset ( = 0.050) and delayed improvement of side effects ( = 0.035) after the Soberana vaccine compared with the Sinopharm vaccine. There was not any statistically significant difference regarding gastrointestinal side effects between the 2 vaccines ( > 0.05).

Conclusion: The cardiovascular and hematological, joint-related (non-neurologic musculoskeletal) and dermatological side effects after the Soberana vaccine appear earlier and end later compared with the Sinopharm vaccine. Improvement of renal side effects in the Sinopharm vaccine group and improvement of neurological and respiratory side effects in the Soberana vaccine group occurred with delay compared with other vaccines.

References

Kooranifar S, Sadeghipour A, Riahi T, Goodarzi A, Tabrizi S, Davoody N . Histopathologic survey on lung necropsy specimens of 15 patients who died from COVID-19: A large study from Iran with a high rate of anthracosis. Med J Islam Repub Iran. 2021; 35:63. PMC: 8278026. DOI: 10.47176/mjiri.35.63. View

Najar Nobari N, Seirafianpour F, Dodangeh M, Sadeghzadeh-Bazargan A, Behrangi E, Mozafarpoor S . A systematic review of the histopathologic survey on skin biopsies in patients with Corona Virus Disease 2019 (COVID-19) who developed virus or drug-related mucocutaneous manifestations. Exp Dermatol. 2021; 30(9):1233-1253. PMC: 8239817. DOI: 10.1111/exd.14384. View

Mohammad A, Mashayekhi F, Seirafianpour F, Mesgarha M, Goodarzi A . COVID-19 and COVID-19 vaccine-related dermatological reactions: An interesting case series with a narrative review of the potential critical and non-critical mucocutaneous adverse effects related to virus, therapy, and the vaccination. Clin Case Rep. 2022; 10(4):e05775. PMC: 9040420. DOI: 10.1002/ccr3.5775. View

Seirafianpour F, Pourriyahi H, Mesgarha M, Mohammad A, Shaka Z, Goodarzi A . A systematic review on mucocutaneous presentations after COVID-19 vaccination and expert recommendations about vaccination of important immune-mediated dermatologic disorders. Dermatol Ther. 2022; 35(6):e15461. PMC: 9111423. DOI: 10.1111/dth.15461. View

Olson S, Newhams M, Halasa N, Price A, Boom J, Sahni L . Effectiveness of Pfizer-BioNTech mRNA Vaccination Against COVID-19 Hospitalization Among Persons Aged 12-18 Years - United States, June-September 2021. MMWR Morb Mortal Wkly Rep. 2021; 70(42):1483-1488. PMC: 9361838. DOI: 10.15585/mmwr.mm7042e1. View

Ghajari H, Nouhjah S, Shahbazian H, Valizadeh R, Tahery N . Postpartum glucose testing, related factors and progression to abnormal glucose tolerance in a rural population with a known history of gestational diabetes. Diabetes Metab Syndr. 2017; 11 Suppl 1:S455-S458. DOI: 10.1016/j.dsx.2017.03.035. View

Walter E, Talaat K, Sabharwal C, Gurtman A, Lockhart S, Paulsen G . Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021; 386(1):35-46. PMC: 8609605. DOI: 10.1056/NEJMoa2116298. View

Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M . Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021; 385(24):2241-2251. PMC: 8385554. DOI: 10.1056/NEJMoa2109522. View

Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z . Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21(12):1645-1653. PMC: 8238449. DOI: 10.1016/S1473-3099(21)00319-4. View

10.

Aiano F, Campbell C, Saliba V, Ramsay M, Ladhani S . COVID-19 vaccine given to children with comorbidities in England, December 2020-June 2021. Arch Dis Child. 2021; 107(3):e16. PMC: 8862071. DOI: 10.1136/archdischild-2021-323162. View

11.

Hodgson S, Mansatta K, Mallett G, Harris V, Emary K, Pollard A . What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2020; 21(2):e26-e35. PMC: 7837315. DOI: 10.1016/S1473-3099(20)30773-8. View

12.

Sadeghzadeh-Bazargan A, Rezai M, Najar Nobari N, Mozafarpoor S, Goodarzi A . Skin manifestations as potential symptoms of diffuse vascular injury in critical COVID-19 patients. J Cutan Pathol. 2021; 48(10):1266-1276. PMC: 8239514. DOI: 10.1111/cup.14059. View

13.

Kuehn B . COVID-19 Vaccine Highly Effective Against Adolescent Hospitalizations. JAMA. 2021; 326(20):2002. DOI: 10.1001/jama.2021.20143. View

14.

Beatty A, Peyser N, Butcher X, Cocohoba J, Lin F, Olgin J . Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination. JAMA Netw Open. 2021; 4(12):e2140364. PMC: 8696570. DOI: 10.1001/jamanetworkopen.2021.40364. View

15.

Cui X, Zhao Z, Zhang T, Guo W, Guo W, Zheng J . A systematic review and meta-analysis of children with coronavirus disease 2019 (COVID-19). J Med Virol. 2020; 93(2):1057-1069. PMC: 7436402. DOI: 10.1002/jmv.26398. View

16.

Schleiss M, John C, Permar S . Children are the key to the Endgame: A case for routine pediatric COVID vaccination. Vaccine. 2021; 39(38):5333-5336. PMC: 8358829. DOI: 10.1016/j.vaccine.2021.08.005. View

17.

Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R . Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021; 385(12):1078-1090. PMC: 8427535. DOI: 10.1056/NEJMoa2110475. View

18.

Bozkurt B, Kamat I, Hotez P . Myocarditis With COVID-19 mRNA Vaccines. Circulation. 2021; 144(6):471-484. PMC: 8340726. DOI: 10.1161/CIRCULATIONAHA.121.056135. View

19.

Tavakoli N, Nafissi N, Shokri S, Fallahpour M, Soleimani S, Riahi T . Pediatric and adolescent COVID-19 vaccination side effects: A retrospective cohort study of the Iranian teenage group in 2021. J Med Virol. 2022; 94(10):4890-4900. PMC: 9349687. DOI: 10.1002/jmv.27962. View

20.

Barbari A . COVID-19 Vaccine Concerns: Fact or Fiction?. Exp Clin Transplant. 2021; 19(7):627-634. DOI: 10.6002/ect.2021.0056. View