Post-marketing safety surveillance for both CRM197 and TT carrier proteins PCV13 in Jiangsu, China.
adverse reaction
carrier protein
pneumococcal polysaccharide conjugate vaccine
post-marketing surveillance
safety
vaccine
Journal
Frontiers in public health
ISSN: 2296-2565
Titre abrégé: Front Public Health
Pays: Switzerland
ID NLM: 101616579
Informations de publication
Date de publication:
2023
2023
Historique:
received:
04
08
2023
accepted:
28
09
2023
medline:
2
11
2023
pubmed:
1
11
2023
entrez:
1
11
2023
Statut:
epublish
Résumé
This study is to evaluate the safety of two kinds of PCV13 carriers by monitoring the occurrence of adverse event following immunization (AEFI) after the launch of two kinds of PCV13 carriers in Jiangsu Province, China. The AEFI Information System (CNAEFIS) of mainland China was used to monitor the incidence and classification of adverse reactions of the CRM197-carrier protein PCV13 and TT-carrier protein PCV13 vaccines. There was no statistical difference between the cumulative reported incidence of AEFI between the two vaccines from 2020 to 2022 ( Both vaccines perform well in terms of safety. We did not identify any new/unexpected safety concern from the NAEFISS during a 4 years timespan.
Sections du résumé
Background
This study is to evaluate the safety of two kinds of PCV13 carriers by monitoring the occurrence of adverse event following immunization (AEFI) after the launch of two kinds of PCV13 carriers in Jiangsu Province, China.
Methods
The AEFI Information System (CNAEFIS) of mainland China was used to monitor the incidence and classification of adverse reactions of the CRM197-carrier protein PCV13 and TT-carrier protein PCV13 vaccines.
Results
There was no statistical difference between the cumulative reported incidence of AEFI between the two vaccines from 2020 to 2022 (
Conclusion
Both vaccines perform well in terms of safety. We did not identify any new/unexpected safety concern from the NAEFISS during a 4 years timespan.
Identifiants
pubmed: 37908689
doi: 10.3389/fpubh.2023.1272562
pmc: PMC10613985
doi:
Substances chimiques
CRM197 (non-toxic variant of diphtheria toxin)
08VC9WC084
Bacterial Proteins
0
Carrier Proteins
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1272562Informations de copyright
Copyright © 2023 Hu, Liu, Zhang, Kang, Xu, Li, Yu, Zhu, Guo and Wang.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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