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. 2022 Jun 1;41(6):507-513.
doi: 10.1097/INF.0000000000003521. Epub 2022 May 6.

Severity of Rotavirus-Vaccine-Associated Intussusception: Prospective Hospital-Based Surveillance, Australia, 2007-2018

Meru Sheel  1   2   3   4 , Nicholas Wood  1   2 , Kristine Macartney  1   2 , Jim Buttery  5   6 , Nicole Dinsmore  1 , Helen Marshall  7 , Elizabeth Elliott  2   8 , Anne Kynaston  9 , Peter Richmond  10   11 , Dan Chateau  3 , Peter McIntyre  1   2 ; PAEDS Network
Affiliations

Severity of Rotavirus-Vaccine-Associated Intussusception: Prospective Hospital-Based Surveillance, Australia, 2007-2018

Meru Sheel et al. Pediatr Infect Dis J. .

Abstract

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.

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Conflict of interest statement

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.

References

    1. Murphy TV, Gargiullo PM, Massoudi MS, et al.; Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344:564–572.
    1. Australian Technical Advisory Group on Immunisation (ATAGI). The Australian immunisation handbook. 10th ed. Australian Government Department of Health and Ageing; 2018.
    1. Carlin JB, Macartney KK, Lee KJ, et al. Intussusception risk and disease prevention associated with rotavirus vaccines in Australia’s National Immunization Program. Clin Infect Dis. 2013;57:1427–1434.
    1. Patel MM, López-Collada VR, Bulhões MM, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl J Med. 2011;364:2283–2292.
    1. Buttery JP, Danchin MH, Lee KJ, et al.; PAEDS/APSU Study Group. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine. 2011;29:3061–3066.

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