Ashley T Longley, Kashmira Date, Stephen P Luby, Pankaj Bhatnagar, Adwoa D Bentsi-Enchill, Vineet Goyal, Rahul Shimpi, Arun Katkar, Vijay Yewale, Niniya Jayaprasad, Lily Horng, Abhishek Kunwar, Pauline Harvey, Pradeep Haldar, Shanta Dutta, Jane F Gidudu
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2021 Aug 16In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV; Typbar-TCV). While no safety concerns were identified in pre- and postlicensure studies, WHO's Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July-August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world's first public sector TCV introduction. Per administrative reports, 113 420 children 9 months-14 years old received TCV. We evaluated adverse events following immunization (AEFIs) using passive and active surveillance via (1) reports from the passive NMMC AEFI surveillance system, (2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days postvaccination, and (3) chart abstraction for adverse events of special interest (AESIs) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status. We identified 222/113 420 (0.2%) vaccine recipients with AEFIs through the NMMC AEFI surveillance system: 211 (0.19%) experienced minor AEFIs, 2 (0.002%) severe, and 9 serious (0.008%). At 48 hours postvaccination, 1852/5605 (33%) caregivers reported ≥1 AEFI, including injection site pain (n = 1452, 26%), swelling (n = 419, 7.5%), and fever (n = 416, 7.4%). Of the 4728 interviews completed at 7 days postvaccination, the most reported AEFIs included fever (n = 200, 4%), pain (n = 52, 1%), and headache (n = 42, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESIs were causally associated with TCV. No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months-14 years old. © The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.
Ashley T Longley, Kashmira Date, Stephen P Luby, Pankaj Bhatnagar, Adwoa D Bentsi-Enchill, Vineet Goyal, Rahul Shimpi, Arun Katkar, Vijay Yewale, Niniya Jayaprasad, Lily Horng, Abhishek Kunwar, Pauline Harvey, Pradeep Haldar, Shanta Dutta, Jane F Gidudu. Evaluation of Vaccine Safety After the First Public Sector Introduction of Typhoid Conjugate Vaccine-Navi Mumbai, India, 2018. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2021 Aug 16;73(4):e927-e933
PMID: 33502453
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