A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5-17 Years) Living in Saudi Arabia

Marya Ahsan; Riyaz Ahamed Shaik; Ayaz K Mallick; Saeed S Banawas; Thamer A M Alruwaili; Yousef Abud Alanazi; Hayat Saleh Alzahrani; Ritu Kumar Ahmad; Mohammad Shakil Ahmad; Faisal Holil AlAnazi; Fahad Alfhaid; Mohammed Zaid Aljulifi; Vini Mehta; Abdalah Emad Almhmd; Abdulaziz S D Al Daham; Mutlaq M M Alruwaili

doi:10.3390/vaccines11020207

A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5-17 Years) Living in Saudi Arabia

Vaccines (Basel). 2023 Jan 17;11(2):207. doi: 10.3390/vaccines11020207.

Authors

Marya Ahsan¹, Riyaz Ahamed Shaik², Ayaz K Mallick³, Saeed S Banawas^{4

5}, Thamer A M Alruwaili⁶, Yousef Abud Alanazi⁷, Hayat Saleh Alzahrani⁸, Ritu Kumar Ahmad⁹, Mohammad Shakil Ahmad², Faisal Holil AlAnazi¹⁰, Fahad Alfhaid², Mohammed Zaid Aljulifi², Vini Mehta¹¹, Abdalah Emad Almhmd¹², Abdulaziz S D Al Daham¹³, Mutlaq M M Alruwaili¹³

Affiliations

¹ Department of Pharmacology, College of Medicine, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh 13317, Saudi Arabia.
² Department of Family & Community Medicine, College of Medicine, Majmaah University, Al Majmaah 11952, Saudi Arabia.
³ Department of Clinical Biochemistry, College of Medicine, King Khalid University, Abha 61421, Saudi Arabia.
⁴ Department of Medical Laboratories, College of Applied Medical Science, and Health and Basic Sciences Research Center, Majmaah University, Majmaah 11952, Saudi Arabia.
⁵ Departments of Biomedical Sciences and Microbiology, Oregon State University, Corvallis, OR 97331, USA.
⁶ Department of Pediatrics, College of Medicine, Jouf University, Aljouf 72388, Saudi Arabia.
⁷ Department of Pediatrics, College of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.
⁸ Department of Clinical Science, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh 11671, Saudi Arabia.
⁹ Department of Physiotherapy, College of Applied Medical Science, Buraydah Private Colleges, Buraydah 51418, Saudi Arabia.
¹⁰ Department of Medicine, College of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.
¹¹ Department of Public Health Dentistry, Dr.D.Y.Patil Dental College and Hospital, Dr.D.Y.Patil Vidyapeeth, Pune 411018, India.
¹² College of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.
¹³ College of Medicine, Jouf University, Aljouf 72388, Saudi Arabia.

Abstract

The objective of this study is to assess the frequency and severity of adverse events following immunization (AEFI) in Indian children aged 5-17 years who received the Pfizer-BioNTech mRNA COVID-19 vaccine, as well as to investigate for predictors of AEFI. To examine AEFI following the first and second doses of Pfizer's vaccine, semi-structured questionnaires were distributed as Google forms at Indian schools in Saudi Arabia. The 385 responses included 48.1% male and 51.9% female children, with 136 responses of children aged 5-11 years (group A) and 249 responses from children aged 12-17 years (group B). Overall, 84.4% of children had two shots. The frequency of AEFI was reported to be higher after the first dose than after the second (OR = 2.12, 95% CI = 1.57-2.86). The reported AEFIs included myalgia, rhinitis, local reaction with fever, a temperature of 102 °F or higher, and mild to moderate injection site reactions. While group B frequently reported multiple AEFIs, group A typically reported just one. Local reaction with low grade fever was more frequently reported in group B after the first dose (24.1%) and second dose (15.4%), while local reaction without low grade fever was most frequently observed in group A after the first (36.8%) and second dose (30%). Only prior COVID-19 infection (OR = 2.98, 95% CI = 1.44-6.2) was associated with AEFI after the second dose in the study sample, whereas male gender (OR = 1.71, 95% CI = 1.13-2.6) and prior COVID-19 infection (OR = 2.95, 95% CI = 1.38-6.3) were predictors of AEFI after the first dose. Non-serious myocarditis was reported by only one child. According to the analysis conducted, the Pfizer's mRNA COVID-19 vaccination was found to be safe in Indian children.

Keywords: COVID-19; adverse events following immunization (AEFI); adverse events of special interest (AESI); mRNA vaccine; myocarditis.

Grants and funding

The authors extend their appreciation to the deputyship for Research & Innovation, Ministry of Education in Saudi Arabia for funding this research work through the project number (IFP-2020-134).