TY - JOUR
T1 - Severity of Rotavirus-Vaccine-Associated Intussusception
T2 - Prospective Hospital-Based Surveillance, Australia, 2007-2018
AU - Sheel, Meru
AU - Wood, Nicholas
AU - Macartney, Kristine
AU - Buttery, Jim
AU - Dinsmore, Nicole
AU - Marshall, Helen
AU - Elliott, Elizabeth
AU - Kynaston, Anne
AU - Richmond, Peter
AU - Chateau, Dan
AU - McIntyre, Peter
N1 - Funding Information:
H.M. and P.R. are investigators on clinical vaccine trials supported by industry. Employing institution for H.M. receives funding from GSK, Pfizer, and Sanofi-Pasteur for investigator-led research. Employing institution for P.R. receives funding from GSK, Pfizer, Sanofi-Pasteur, and Merck for investigator-led research and participation in scientific advisory boards. P.R. has previously chaired the data safety monitoring boards for the RV3-BB rotavirus vaccine. H.M. and P.R. receive no personal payments from the industry. For the remaining authors, there are no conflicts of interest.
Funding Information:
PAEDS is supported by the Australian Government Department of Health and Departments of Health in New South Wales, Victoria, Queensland, South Australia, Western Australia, and the Northern Territory. This work was supported by the Australian National Health and Medical Research Council (NHMRC) including; PAEDS which is funded by an NHMRC Partnership Grant (GNT1113851), NW is funded by the NHMRC Career Development Fellowship (GNT1063629), HM is supported by NHMRC Practitioner Fellowships (APP1155066) and EE by a Medical Research Futures Fund Next Generation Fellowship (MRF1135959). We acknowledge the support of the Australian Government Department of Health and Departments of Health in New South Wales, Victoria, Queensland, South Australia, Western Australia, and the Northern Territory. MS is supported by a fellowship from the Westpac Scholars Trust. This study was supported by funding from all these entities.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - Background: Multiple studies have shown an association between intussusception (IS) and receipt of monovalent or pentavalent rotavirus vaccine (RV) in the previous 21 days. Disease severity is an important consideration for risk-benefit evaluations of RV, but no studies have compared the severity of IS within 21 days of vaccination (vaccine-associated, VA) and later (not temporally-associated, VNA). Methods: We used active hospital-based surveillance in the Australian Paediatric Active Enhanced Disease Surveillance (PAEDS) network (July 2007 to February 2018) to identify infants ≤9 months of age meeting Brighton level 1 criteria for IS. We used five severity levels: (1) no surgery and length of stay (LOS) ≤1 day, (2) no surgery and LOS ≥2 days, (3) surgery, no bowel resection, (4) bowel resection, and (5) ICU admission. Results: Of 323 eligible cases, 87 (26.9%) were VA and 236 (73.1%) VNA. VA-IS cases (median 21 weeks; 24.1% ≤14 weeks) were significantly younger than VNA-IS cases (median 28 weeks, 7.2% ≤14 weeks). Cases 0-≤14 weeks of age were significantly more likely than cases ≥25 weeks to require bowel resection (relative risk ratio 4.6, 95% CI, 1.48-14.3). This effect was not associated with RV. After adjustment for age and sex, VA-IS was not significantly overrepresented in severity levels 2-5; adjusted RRR of 1.37 (95% CI: 0.61-3.11) for bowel resection in cases 0-≤14 weeks of age. Conclusions: IS was uncommon but significantly more severe under 14 weeks of age. After adjustment for age and sex, IS severity was not related to RV.
AB - Background: Multiple studies have shown an association between intussusception (IS) and receipt of monovalent or pentavalent rotavirus vaccine (RV) in the previous 21 days. Disease severity is an important consideration for risk-benefit evaluations of RV, but no studies have compared the severity of IS within 21 days of vaccination (vaccine-associated, VA) and later (not temporally-associated, VNA). Methods: We used active hospital-based surveillance in the Australian Paediatric Active Enhanced Disease Surveillance (PAEDS) network (July 2007 to February 2018) to identify infants ≤9 months of age meeting Brighton level 1 criteria for IS. We used five severity levels: (1) no surgery and length of stay (LOS) ≤1 day, (2) no surgery and LOS ≥2 days, (3) surgery, no bowel resection, (4) bowel resection, and (5) ICU admission. Results: Of 323 eligible cases, 87 (26.9%) were VA and 236 (73.1%) VNA. VA-IS cases (median 21 weeks; 24.1% ≤14 weeks) were significantly younger than VNA-IS cases (median 28 weeks, 7.2% ≤14 weeks). Cases 0-≤14 weeks of age were significantly more likely than cases ≥25 weeks to require bowel resection (relative risk ratio 4.6, 95% CI, 1.48-14.3). This effect was not associated with RV. After adjustment for age and sex, VA-IS was not significantly overrepresented in severity levels 2-5; adjusted RRR of 1.37 (95% CI: 0.61-3.11) for bowel resection in cases 0-≤14 weeks of age. Conclusions: IS was uncommon but significantly more severe under 14 weeks of age. After adjustment for age and sex, IS severity was not related to RV.
KW - immunization
KW - intussusception
KW - morbidity
KW - postmarketing surveillance
KW - rotavirus vaccine
KW - RV1
KW - RV5
KW - severity
UR - http://www.scopus.com/inward/record.url?scp=85130004327&partnerID=8YFLogxK
U2 - 10.1097/INF.0000000000003521
DO - 10.1097/INF.0000000000003521
M3 - Article
C2 - 35363642
AN - SCOPUS:85130004327
SN - 0021-9355
VL - 41
SP - 507
EP - 513
JO - The Journal of Bone & Joint Surgery
JF - The Journal of Bone & Joint Surgery
IS - 6
ER -
