PMID- 36680039
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 11
IP  - 1
DP  - 2023 Jan 16
TI  - COVID-19 mRNA Vaccine Tolerance and Immunogenicity in Hematopoietic Stem Cell 
      Transplantation Recipients Aged 5-11 Years Old-Non-Randomized Clinical Trial.
LID - 10.3390/vaccines11010195 [doi]
LID - 195
AB  - 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 
      microg) 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.
FAU - Matkowska-Kocjan, Agnieszka
AU  - Matkowska-Kocjan A
AD  - Department and Clinic of Pediatric Infectious Diseases, Wroclaw Medical 
      University, 50-368 Wroclaw, Poland.
FAU - Owoc-Lempach, Joanna
AU  - Owoc-Lempach J
AD  - Department and Clinic of Paediatric Oncology, Haematology and Bone Marrow 
      Transplantation, Wroclaw Medical University, 50-556 Wroclaw, Poland.
FAU - Ludwikowska, Kamila
AU  - Ludwikowska K
AUID- ORCID: 0000-0002-4128-3401
AD  - Department and Clinic of Pediatric Infectious Diseases, Wroclaw Medical 
      University, 50-368 Wroclaw, Poland.
FAU - Szenborn, Filip
AU  - Szenborn F
AD  - Faculty of Electronics, Wroclaw University of Science and Technology, 50-370 
      Wroclaw, Poland.
FAU - Moskwa, Natalia
AU  - Moskwa N
AD  - Department and Clinic of Pediatric Infectious Diseases, Wroclaw Medical 
      University, 50-368 Wroclaw, Poland.
FAU - Kurek, Katarzyna
AU  - Kurek K
AD  - Department and Clinic of Pediatric Infectious Diseases, Wroclaw Medical 
      University, 50-368 Wroclaw, Poland.
FAU - Kalwak, Krzysztof
AU  - Kalwak K
AD  - Department and Clinic of Paediatric Oncology, Haematology and Bone Marrow 
      Transplantation, Wroclaw Medical University, 50-556 Wroclaw, Poland.
FAU - Szenborn, Leszek
AU  - Szenborn L
AD  - Department and Clinic of Pediatric Infectious Diseases, Wroclaw Medical 
      University, 50-368 Wroclaw, Poland.
FAU - Ussowicz, Marek
AU  - Ussowicz M
AUID- ORCID: 0000-0001-5725-4835
AD  - Department and Clinic of Paediatric Oncology, Haematology and Bone Marrow 
      Transplantation, Wroclaw Medical University, 50-556 Wroclaw, Poland.
LA  - eng
GR  - SUBZ.C200.22.067 and SUB.C180.21.080/Wroclaw Medical University statutory grant/
PT  - Journal Article
DEP - 20230116
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC9866698
OTO - NOTNLM
OT  - COVID-19
OT  - HSCT
OT  - children
OT  - vaccinations
COIS- The authors declare no conflict of interest.
EDAT- 2023/01/22 06:00
MHDA- 2023/01/22 06:01
PMCR- 2023/01/16
CRDT- 2023/01/21 01:57
PHST- 2022/11/28 00:00 [received]
PHST- 2022/12/28 00:00 [revised]
PHST- 2023/01/06 00:00 [accepted]
PHST- 2023/01/21 01:57 [entrez]
PHST- 2023/01/22 06:00 [pubmed]
PHST- 2023/01/22 06:01 [medline]
PHST- 2023/01/16 00:00 [pmc-release]
AID - vaccines11010195 [pii]
AID - vaccines-11-00195 [pii]
AID - 10.3390/vaccines11010195 [doi]
PST - epublish
SO  - Vaccines (Basel). 2023 Jan 16;11(1):195. doi: 10.3390/vaccines11010195.