Post-marketing surveillance of intussusception after Rotarix administration in Afghanistan, 2018-2022.

Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE

Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-

Rotavirus Vaccines*/adverse effects ; Intussusception*/chemically induced ; Intussusception*/epidemiology ; Rotavirus Infections*/epidemiology ; Rotavirus Infections*/prevention & control ; Rotavirus Infections*/complications; Infant ; Humans ; Afghanistan/epidemiology ; Prospective Studies ; Vaccines, Attenuated/adverse effects ; Vaccination/adverse effects ; Product Surveillance, Postmarketing

Background: In January 2018, Afghanistan introduced the monovalent oral rotavirus vaccine (Rotarix) nationwide, administered as a 2-dose series at six and ten weeks of age. We describe characteristics of intussusception cases and assess potential intussusception risk associated with Rotarix vaccination in Afghan infants.
Methods: Multi-center prospective active hospital-based surveillance for intussusception was conducted from May 2018 to March 2022 in four sentinel sites in Afghanistan. We applied the Brighton Level 1 criteria for intussusception and verified vaccination status by reviewing vaccine cards. We used the self-controlled case series (SCCS) methodology to compare intussusception incidence in the 1 to 21 days after each dose of Rotarix vaccination against non-risk periods.
Results: A total of 468 intussusception cases were identified in infants under 12 months, with 264 cases aged between 28 and 245 days having confirmed vaccination status contributing to the SCCS analysis. Most case-patients (98 %) required surgery for treatment, and over half (59 %) of those who underwent surgery required intestinal resection. Nineteen (7 %) case-patients died. Eighty-six percent of case-patients received the first dose of Rotarix, and 69 % received the second dose before intussusception symptom onset. There was no increased risk of intussusception in the 1-7 days (relative incidence: 0.9, 95 % CI: 0.1, 7.5), 8-21 days (1.3, 95 % CI: 0.4, 4.2), or 1-21 days (1.1, 95 % CI: 0.4, 3.4) following receipt of the first dose or in the 1-7 days (0.2, 95 % CI: 0.3, 1.8), 8-21 days (0.7, 95 % CI: 0.3, 1.5), or 1-21 days (0.6, 95 % CI: 0.3, 1.2) following the second dose.
Conclusion: Rotarix vaccination was not associated with an increased intussusception risk, supporting its continued use in Afghanistan's immunization program. However, there was a high level of death and resection due to intussusception among Afghan infants.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

PLoS One. 2013 Jul 22;8(7):e68482. (PMID: 23894308)
Vaccine. 2022 Mar 15;40(12):1707-1711. (PMID: 35184924)
Vaccine. 2006 Feb 27;24(9):1483-7. (PMID: 16226829)
N Engl J Med. 2018 Apr 19;378(16):1521-1528. (PMID: 29669224)
Vaccine. 2023 Nov 22;41(48):7220-7225. (PMID: 37884416)
Pediatr Infect Dis J. 2020 Dec;39(12):1127-1130. (PMID: 33060518)
Vaccine. 2004 Jan 26;22(5-6):569-74. (PMID: 14741146)
Vaccine. 2020 Sep 11;38(40):6299-6303. (PMID: 32736940)
JAMA Netw Open. 2019 Oct 2;2(10):e1912458. (PMID: 31584679)
Clin Infect Dis. 2020 Apr 10;70(8):1606-1612. (PMID: 31125061)
Stat Med. 2006 May 30;25(10):1768-97. (PMID: 16220518)
MMWR Morb Mortal Wkly Rep. 1999 Nov 5;48(43):1007. (PMID: 10577495)
J Trop Pediatr. 2017 Jun 1;63(3):221-228. (PMID: 27694631)
MMWR Recomm Rep. 2006 Aug 11;55(RR-12):1-13. (PMID: 16902398)
J Infect Dis. 2003 Apr 15;187(8):1309-13. (PMID: 12696011)
Clin Infect Dis. 2024 Jan 25;78(1):210-216. (PMID: 37596934)
Lancet Glob Health. 2019 Nov;7(11):e1541-e1552. (PMID: 31607466)
Stat Methods Med Res. 2009 Feb;18(1):7-26. (PMID: 18562396)
Pediatrics. 2022 Jun 1;149(6):. (PMID: 35322271)
MMWR Recomm Rep. 2009 Feb 6;58(RR-2):1-25. (PMID: 19194371)
N Engl J Med. 2020 Nov 12;383(20):1932-1940. (PMID: 33176083)
Pediatr Infect Dis J. 2001 Apr;20(4):410-6. (PMID: 11332666)

CC999999 United States ImCDC Intramural CDC HHS

Keywords: Afghanistan; Infant; Intussusception; Rotavirus vaccine; Self-controlled case-series; Vaccine safety

0 (RIX4414 vaccine)
0 (Rotavirus Vaccines)
0 (Vaccines, Attenuated)

Date Created: 20240227 Date Completed: 20240318 Latest Revision: 20240809

20240809

PMC11308983

10.1016/j.vaccine.2024.02.057

38413278