ABSTRACT
The COVID-19 pandemic has severely affected adolescents. Safe and effective vaccines are pivotal tools in controlling this pandemic. We reviewed the safety profile of the BNT162b2 COVID-19 vaccine in adolescents using mostly real-world data to assist decision-making. We used random-effects model meta-analysis to derive pooled rates of single or grouped adverse events following immunization (AEFI) after each primary and booster dose, as well as after combining all doses. Reporting on over one million participants with safety data were included. The most-reported local and systemic AEFIs were pain/swelling/erythema/redness and fatigue/headache/myalgia, respectively. AESIs were rarely reported but were more frequent after the second dose than they were after the first and the booster doses. Health impact was less common among adolescents after receiving BNT162b2 vaccine. Rare life-threatening AEFIs were reported across all doses in real-world studies. Our findings highlight the significance of enhancing national and regional vaccination programs to ensure public confidence.
Acknowledgments
We acknowledge the South African Medical Research Council for supporting the work of some of the authors and for providing funding for open access publication of this study. AB is partly supported by the Research, Evidence and Development Initiative (READ-It). READ-It (project number 300342-104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s official policies
Data sharing
All data generated or analyzed during this study are included in this published article and the appendix.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Author contributions
PK, CSW and GG conceived the study. PK and TM did the literature search. PK and LB did the study selection. AB, LB, MK, and PK extracted the relevant information. PK accessed and verified the data. PK and JT synthesized the data. PK wrote the first draft of the paper. CSW and GG supervised the overall work. All authors critically revised successive drafts of the paper. All authors had full access to all the data in the study, read, and approved the final manuscript, and had final responsibility for the decision to submit for publication
Supplementary material
Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2022.2144039.