Immunogenicity and reactogenicity of COVID-19 Pfizer-BioNTech (Bnt162b2) mRNA vaccination in immunocompromised adolescents and young adults: a systematic review and meta-analyses

ABSTRACT

Background

This study aimed to evaluate the safety and effectiveness of the BNT162b2 vaccine in immunocompromised adolescents and young adults.

Research design and methods

The study conducted a meta-analysis of post-marketing studies examining BNT162b2 vaccination efficacy and safety among immunocompromised adolescents and young adults worldwide. The review included nine studies and 513 individuals aged between 12 and 24.3 years. The study used a random effect model to estimate pooled proportions, log relative risk, and mean difference, and assessed heterogeneity using the I2 test. The study also examined publication bias using Egger’s regression and Begg’s rank correlation and assessed bias risk using ROBINS-I.

Results

The pooled proportions of combined local and systemic reactions after the first and second doses were 30% and 32%, respectively. Adverse events following immunization (AEFI) were most frequent in rheumatic diseases (40%) and least frequent in cystic fibrosis (27%), although hospitalizations for AEFIs were rare. The pooled estimations did not show a statistically significant difference between immunocompromised individuals and healthy controls for neutralizing antibodies, measured IgG, or vaccine effectiveness after the primary dose. However, the evidence quality is low to moderate due to a high risk of bias, and no study could rule out the risk of selection bias, ascertainment bias, or selective outcome reporting.

Conclusions

This study provides preliminary evidence that the BNT162b2 vaccine is safe and effective in immunocompromised adolescents and young adults, but with low to moderate evidence quality due to bias risk. The study calls for improved methodological quality in studies involving specific populations.

KEYWORDS:

• SARS-CoV-2
• children
• comorbidity
• immunization
• post marketing

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.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data sharing

All data generated or analyzed during this study are included in this published Article and the appendix.

Author contributions

P Katoto, CS Wiysonge and G Gray conceived the study. P Katoto, L Byamungu and M Kakubu did the literature search. P Katoto and L Byamungu did the study selection. J Tamuzi, L Byamungu, A Brand, and P Katoto extracted the relevant information. P Katoto accessed and verified the data. A Brand supervised the risk of study section. P Katoto and J Tamuzi synthesized the data. P Katoto, M Kakubu, A Ayuk, L Byamungu and A Brand wrote the first draft. CS Wiysonge and G Gray 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 online at https://doi.org/10.1080/14760584.2023.2204154

Additional information

Funding

This paper was not funded.