Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in Five Countries in Africa.
Africa
Rotavirus
intussusception
rotavirus vaccine
vaccine safety
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
19 Aug 2023
19 Aug 2023
Historique:
received:
15
06
2023
revised:
07
08
2023
accepted:
16
08
2023
medline:
19
8
2023
pubmed:
19
8
2023
entrez:
19
8
2023
Statut:
aheadofprint
Résumé
A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from five African countries that introduced RotaTeq into their national immunization program. Active surveillance was conducted in 20 sentinel sites to identify intussusception cases. A standard case report form was completed for each enrolled child and vaccination status was determined by review of the child's vaccination card or clinic record. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants 28 to 245 days of age. Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared to the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence=2.71, 95% confidence interval (CI)=0.47-8.03) or the 8-21 day window (relative incidence=0.77, 95%CI=0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or dose 3. RotaTeq vaccination was not associated with an increased risk of intussusception in this pooled analysis from five African countries. This finding mirrors what was reported in similar analyses with other rotavirus vaccines in low-income settings and highlights need for vaccine-specific and setting-specific risk monitoring.
Sections du résumé
BACKGROUND
BACKGROUND
A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from five African countries that introduced RotaTeq into their national immunization program.
METHODS
METHODS
Active surveillance was conducted in 20 sentinel sites to identify intussusception cases. A standard case report form was completed for each enrolled child and vaccination status was determined by review of the child's vaccination card or clinic record. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants 28 to 245 days of age.
RESULTS
RESULTS
Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared to the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence=2.71, 95% confidence interval (CI)=0.47-8.03) or the 8-21 day window (relative incidence=0.77, 95%CI=0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or dose 3.
CONCLUSIONS
CONCLUSIONS
RotaTeq vaccination was not associated with an increased risk of intussusception in this pooled analysis from five African countries. This finding mirrors what was reported in similar analyses with other rotavirus vaccines in low-income settings and highlights need for vaccine-specific and setting-specific risk monitoring.
Identifiants
pubmed: 37596934
pii: 7246285
doi: 10.1093/cid/ciad492
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.