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. 2023 Jan 16;11(1):195.
doi: 10.3390/vaccines11010195.

COVID-19 mRNA Vaccine Tolerance and Immunogenicity in Hematopoietic Stem Cell Transplantation Recipients Aged 5-11 Years Old-Non-Randomized Clinical Trial

Agnieszka Matkowska-Kocjan  1 , Joanna Owoc-Lempach  2 , Kamila Ludwikowska  1 , Filip Szenborn  3 , Natalia Moskwa  1 , Katarzyna Kurek  1 , Krzysztof Kałwak  2 , Leszek Szenborn  1 , Marek Ussowicz  2
Affiliations

COVID-19 mRNA Vaccine Tolerance and Immunogenicity in Hematopoietic Stem Cell Transplantation Recipients Aged 5-11 Years Old-Non-Randomized Clinical Trial

Agnieszka Matkowska-Kocjan et al. Vaccines (Basel). .

Abstract

The SARS-CoV-2 pandemic had a devastating impact on the world’s population in the years 2020−2022. The rapid development of vaccines enabled a reduction in the mortality and morbidity of COVID-19, but there are limited data about their effects on immunocompromised children. The aim of this prospective study was to evaluate the safety and efficacy of the mRNA BNT162b2 (Pfizer/Biontech) vaccine in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Material and methods: Two cohorts of 34 children after allo-HSCT and 35 healthy children aged 5−11 years were vaccinated with two doses of the mRNA BNT162b2 (10 µg) vaccine. All children were evaluated for adverse effects with electronic surveys and the immunogenicity of the vaccine was assessed with anti-SARS-CoV-2 IgG titer measurements. Results: All reported adverse events (AEs) were classified as mild. The most common AE was pain at the injection site. All the other AEs (both local and systemic) were rarely reported (<15% patients). Both groups showed a similar response in anti-SARS-CoV-2 IgG production. Patients after allo-HSCT that were undergoing immunosuppressive treatment presented a poorer immunological response than patients off of treatment. Time since HSCT, patient age, lymphocyte count, and total IgG concentration did not correlate with initial/post-vaccination anti-SARS-CoV-2 IgG titers. Most patients who were eligible for a third dose of the vaccine had an excellent humoral response observed after two vaccine doses. Conclusions: The COVID-19 mRNA BNT162b2 vaccine is very well tolerated and highly immunogenic in 5−11-year-old children after HSCT. Children >2 years of age after HSCT who did not receive immunosuppressive treatment presented excellent antibody production after two doses of the vaccine, but children on immunosuppression may require a more intense vaccination schedule.

Keywords: COVID-19; HSCT; children; vaccinations.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The vaccination scheme.
Figure 2
Figure 2
Flowchart of the study.
Figure 3
Figure 3
Comparison of the concentration of anti-SARS-CoV-2 specific antibodies in (A) HSCT recipients and healthy controls before and after vaccination, (B) patients positive before the first dose (Pre-POSITIVE) versus negative (Pre-NEGATIVE), (C) patients showing vaccination-associated symptoms and those who were asymptomatic, and (D) patients on immunosuppressive treatment (on IS) and those off of treatment (off IS). ns: non-significant.
Figure 4
Figure 4
Linear regression analysis of anti-SARS-CoV-2 IgG concentration and (A) time since HSCT and (B) age of the patient. Trend lines are shown as continuous lines, and dotted lines represent 95% confidence intervals. ns: non-significant.
Figure 5
Figure 5
The time patients in the study were vaccinated versus COVID-19 cases reported in Poland.
See this image and copyright information in PMC

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