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

• Published in: Vaccines (Basel) Vol. 9; no. 11; p. 1297
• Main Authors: Alamer, Edrous, Alhazmi, Abdulaziz, Qasir, Naaif A., Alamer, Rahaf, Areeshi, Halima, Gohal, Gassem, Qadri, Marwa, Hashem, Anwar M., Algaissi, Abdullah
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 09.11.2021; MDPI
• Subjects: Age groups; Children; Chronic illnesses; Clinical trials; Coronaviruses; COVID-19; COVID-19 pandemic; COVID-19 vaccines; Disease transmission; Epidemiology; Ethics; Fever; Headache; Immunization; Infectious diseases; mRNA; mRNA vaccines; Nausea; Pain; Pandemics; Pfizer-BioNTech; Polyethylene glycol; Population; Proteins; Questionnaires; Safety; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Side effects; vaccine; Vaccines; Viral diseases; Vomiting; Womens health; Saudi Arabia
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines9111297

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.