Authors
Narges Ebrahimi, Philip de Whalley, Nasir Kanji, Maheshi N Ramasamy, Parvinder K Aley, Sagida Bibi, Elizabeth A Clutterbuck, Andrea M Collins, Thomas C Darton, Christopher J A Duncan, Saul N Faust, Elaine Shuo Feng, Anna L Goodman, Christopher A Green, Paul T Heath, Jonathan Kwok, Rajeka Lazarus, Vincenzo Libri, Patrick J Lillie, Alastair McGregor, Yama F Mujadidi, Nelly Owino, Emma Plested, Katrina M Pollock, Hannah Robinson, Rebecca K Sutherland, Emma C Thomson, Mark Toshner, David P J Turner, Christopher J Williams, Ian Hirsch, Tonya L Villafana, Teresa Lambe, Merryn Voysey, Andrew J Pollard
Published in
Vaccine. Volume 88. Pages 128951. Jul 19, 2026. Epub Jul 19, 2026.
Abstract
Follow-up of pre-licensure trial participants potentially informs a vaccine's long-term safety profile.
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.
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.
Although no emergent safety signals were detected, continued post-marketing surveillance remains imperative, particularly for neurological disorders.
2021-003382-36.
PMID:
42472497
Bibliographic data and abstract were imported from PubMed on 20 Jul 2026.
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