Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia

Edrous Alamer; Abdulaziz Alhazmi; Naaif A Qasir; Rahaf Alamer; Halima Areeshi; Gassem Gohal; Marwa Qadri; Anwar M Hashem; Abdullah Algaissi

doi:10.3390/vaccines9111297

Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia

Vaccines (Basel). 2021 Nov 9;9(11):1297. doi: 10.3390/vaccines9111297.

Authors

Edrous Alamer^{1

2}, Abdulaziz Alhazmi^{2

3}, Naaif A Qasir^{1

2}, Rahaf Alamer^{2

4}, Halima Areeshi², Gassem Gohal⁵, Marwa Qadri^{2

6}, Anwar M Hashem^{7

8}, Abdullah Algaissi^{1

2}

Affiliations

¹ Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, Jazan University, Jazan 45142, Saudi Arabia.
² Emerging and Epidemic Infectious Diseases Research Unit, Medical Research Center, Jazan University, Jazan 45142, Saudi Arabia.
³ Microbiology and Parasitology Department, College of Medicine, Jazan University, Jazan 45142, Saudi Arabia.
⁴ College of Medicine, Jazan University, Jazan 45142, Saudi Arabia.
⁵ Department of Pediatrics, College of Medicine, Jazan University, Jazan 45142, Saudi Arabia.
⁶ Department of Pharmacology and Toxicology, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia.
⁷ Department of Medical Microbiology and Parasitology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia.
⁸ Vaccines and Immunotherapy Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah 21589, Saudi Arabia.

Abstract

Background: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is still important. In this study, we aimed to investigate the early side effects of Pfizer-BioNTech (BNT162b2) mRNA vaccine in children between 12-18 years old in Saudi Arabia. Method: To investigate the side effects in children in this age range following the administration of either one or two doses of Pfizer-BioNTech (BNT162b2) mRNA vaccine, we conducted a retrospective, cross-sectional study using a self-administered online survey. General and demographic data were collected, and vaccine-associated side effects following vaccination were evaluated. Results: The study recruited a total of 965 eligible participants. Overall, 571 (60%) of the study participants reported at least one side effect following Pfizer-BioNTech (BNT162b2) mRNA vaccination. The most frequently reported side effects were pain or redness at the site of injection (90%), fatigue (67%), fever (59%), headache (55%), nausea or vomiting (21%), and chest pain and shortness of breath (20%). Joint or bone pain were reported less frequently among our participants (2%). Our data showed that more female participants reported side effects compared to male participants, with 52% and 48%, respectively. Side effects were more common after the second dose compared to the first dose in our study cohort. Conclusions: While 60% of the children (12-18 years old) who received Pfizer-BioNTech (BNT162b2) mRNA vaccine reported side effects, our data showed that these side effects were not different from those that were reported in the clinical trials which lasted only for a few days. Side effects were more common after the second dose. Larger epidemiological and molecular studies are needed to evaluate the safety and the effectiveness of COVID-19 vaccine in protection of children against SARS-CoV-2 reinfections.

Keywords: COVID-19; COVID-19 pandemic; Pfizer-BioNTech; SARS-CoV-2; children; side effects; vaccine.

Grants and funding

ISP20-2/Deputyship for Research & Innovation, Ministry of Education in Saudi Arabia