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Lookup NU author(s): Dr Christopher DuncanORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2026 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license. http://creativecommons.org/licenses/by/4.0/Rationale: Follow-up of pre-licensure trial participants potentially informs a vaccine's long-term safety profile. Design: This prospective study enrolled participants from the first clinical trials of ChAdOx1 nCoV-19 vaccine, many of whom subsequently received COVID-19 vaccines in the UK vaccination programme. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were captured. AESI selection was based on Brighton Collaboration definitions. Results: Between September 2021 and April 2022, 4470 participants enrolled (58% female, median age 50 years); 3845/4470 (86.0%) completed the study. Median follow-up was 11.77 months; total follow-up was 48,116 person-months. There were 174 SAEs and 71 AESIs (33 events recorded as both) in 195 participants, including 5 deaths. Immunology data were available for a small subset of participants; total IgG against trimeric SARS-CoV-2 spike protein tended to increase during the study. Conclusions: Although no emergent safety signals were detected, continued post-marketing surveillance remains imperative, particularly for neurological disorders. EudraCT number: 2021-003382-36.
Author(s): Ebrahimi N, de Whalley P, Kanji N, Ramasamy MN, Aley PK, Bibi S, Clutterbuck EA, Collins AM, Darton TC, Duncan CJA, Faust SN, Feng ES, Goodman AL, Green CA, Heath PT, Kwok J, Lazarus R, Libri V, Lillie PJ, McGregor A, Mujadidi YF, Owino N, Plested E, Pollock KM, Robinson H, Sutherland RK, Thomson EC, Toshner M, Turner DPJ, Williams CJ, Hirsch I, Villafana TL, Lambe T, Voysey M, Pollard AJ
Publication type: Article
Publication status: Published
Journal: Vaccine
Year: 2026
Volume: 88
Print publication date: 13/08/2026
Online publication date: 18/07/2026
Acceptance date: 14/07/2026
Date deposited: 04/08/2026
ISSN (print): 0264-410X
ISSN (electronic): 1873-2518
Publisher: Elsevier Ltd
URL: https://doi.org/10.1016/j.vaccine.2026.128951
DOI: 10.1016/j.vaccine.2026.128951
Data Access Statement: Data will be made available on request
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