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

Nader Tavakoli; Nahid Nafissi; Sima Shokri; Morteza Fallahpour; Sanaz Soleimani; Taghi Riahi; Saeed Kalantari; Azadeh Goodarzi; Rohollah Valizadeh

doi:10.47176/mjiri.37.15

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

Med J Islam Repub Iran. 2023 Mar 1:37:15. doi: 10.47176/mjiri.37.15. eCollection 2023.

Authors

Nader Tavakoli¹, Nahid Nafissi², Sima Shokri³, Morteza Fallahpour³, Sanaz Soleimani^{4

5}, Taghi Riahi⁶, Saeed Kalantari⁷, Azadeh Goodarzi^{8

9}, Rohollah Valizadeh¹⁰

Affiliations

¹ Department of Emergency Medicine, Trauma and Injury Research Center, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
² Department of General Surgery, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
³ Department of Allergy and Clinical Immunology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
⁴ Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
⁵ Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
⁶ Department of Internal Medicine, School of Medicine, Rasool Akram Medical Complex, Iran University of Medical Sciences, Tehran, Iran.
⁷ Antimicrobial Resistance Research Center, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran.
⁸ Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
⁹ Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
¹⁰ Urmia University of Medical Sciences, Urmia, Iran.

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 (P = 0.012). Cardiovascular and hematological side effects showed early-onset (P = 0.006) and delayed improvement of side effects (P = 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 (P = 0.027). Joint-related side effects showed early-onset (P = 0.004) and delayed improvement of side effects (P = 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 (P = 0.013), and dermatological side effects showed early-onset (P = 0.050) and delayed improvement of side effects (P = 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 (P > 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.

Keywords: Adolescent; Adverse Effect; COVID-19; Children; Pediatric; Delayed; Early; Safety; Sinopharm; Soberana; Vaccination.