dc.contributor.author |
Faksova, K |
|
dc.contributor.author |
Walsh, D |
|
dc.contributor.author |
Jiang, Y |
|
dc.contributor.author |
Griffin, J |
|
dc.contributor.author |
Phillips, A |
|
dc.contributor.author |
Gentile, A |
|
dc.contributor.author |
Kwong, JC |
|
dc.contributor.author |
Macartney, K |
|
dc.contributor.author |
Naus, M |
|
dc.contributor.author |
Grange, Z |
|
dc.contributor.author |
Escolano, S |
|
dc.contributor.author |
Sepulveda, G |
|
dc.contributor.author |
Shetty, A |
|
dc.contributor.author |
Pillsbury, A |
|
dc.contributor.author |
Sullivan, C |
|
dc.contributor.author |
Naveed, Z |
|
dc.contributor.author |
Janjua, NZ |
|
dc.contributor.author |
Giglio, N |
|
dc.contributor.author |
Perälä, J |
|
dc.contributor.author |
Nasreen, S |
|
dc.contributor.author |
Gidding, H |
|
dc.contributor.author |
Hovi, P |
|
dc.contributor.author |
Vo, T |
|
dc.contributor.author |
Cui, F |
|
dc.contributor.author |
Deng, L |
|
dc.contributor.author |
Cullen, L |
|
dc.contributor.author |
Artama, M |
|
dc.contributor.author |
Lu, H |
|
dc.contributor.author |
Clothier, HJ |
|
dc.contributor.author |
Batty, K |
|
dc.contributor.author |
Paynter, J |
|
dc.contributor.author |
Petousis-Harris, H |
|
dc.contributor.author |
Buttery, J |
|
dc.contributor.author |
Black, S |
|
dc.contributor.author |
Hviid, A |
|
dc.coverage.spatial |
Netherlands |
|
dc.date.accessioned |
2024-05-08T03:09:03Z |
|
dc.date.available |
2024-05-08T03:09:03Z |
|
dc.date.issued |
2024-04 |
|
dc.identifier.citation |
(2024). Vaccine, 42(9), 2200-2211. |
|
dc.identifier.issn |
0264-410X |
|
dc.identifier.uri |
https://hdl.handle.net/2292/68298 |
|
dc.description.abstract |
<h4>Background</h4>The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.<h4>Methods</h4>Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.<h4>Results</h4>Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.<h4>Conclusion</h4>This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified. |
|
dc.format.medium |
Print-Electronic |
|
dc.language |
eng |
|
dc.publisher |
Elsevier |
|
dc.relation.ispartofseries |
Vaccine |
|
dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
|
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
|
dc.rights.uri |
https://creativecommons.org/licenses/by/4.0/ |
|
dc.subject |
Humans |
|
dc.subject |
Guillain-Barre Syndrome |
|
dc.subject |
Sinus Thrombosis, Intracranial |
|
dc.subject |
Myocarditis |
|
dc.subject |
Pericarditis |
|
dc.subject |
Vaccination |
|
dc.subject |
Cohort Studies |
|
dc.subject |
Female |
|
dc.subject |
Male |
|
dc.subject |
COVID-19 |
|
dc.subject |
COVID-19 Vaccines |
|
dc.subject |
mRNA Vaccines |
|
dc.subject |
BNT162 Vaccine |
|
dc.subject |
2019-nCoV Vaccine mRNA-1273 |
|
dc.subject |
Adverse events following immunization |
|
dc.subject |
Adverse events of special interest |
|
dc.subject |
Observed vs. expected analysis |
|
dc.subject |
Pharmacovigilance |
|
dc.subject |
Vaccine safety surveillance |
|
dc.subject |
4203 Health Services and Systems |
|
dc.subject |
32 Biomedical and Clinical Sciences |
|
dc.subject |
42 Health Sciences |
|
dc.subject |
Immunization |
|
dc.subject |
Prevention |
|
dc.subject |
Vaccine Related |
|
dc.subject |
3 Prevention of disease and conditions, and promotion of well-being |
|
dc.subject |
3.4 Vaccines |
|
dc.subject |
3 Good Health and Well Being |
|
dc.subject |
06 Biological Sciences |
|
dc.subject |
07 Agricultural and Veterinary Sciences |
|
dc.subject |
11 Medical and Health Sciences |
|
dc.title |
COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals. |
|
dc.type |
Journal Article |
|
dc.identifier.doi |
10.1016/j.vaccine.2024.01.100 |
|
pubs.issue |
9 |
|
pubs.begin-page |
2200 |
|
pubs.volume |
42 |
|
dc.date.updated |
2024-04-30T23:07:49Z |
|
dc.rights.holder |
Copyright: The authors |
en |
dc.identifier.pmid |
38350768 (pubmed) |
|
pubs.author-url |
https://www.ncbi.nlm.nih.gov/pubmed/38350768 |
|
pubs.end-page |
2211 |
|
pubs.publication-status |
Published |
|
dc.rights.accessrights |
http://purl.org/eprint/accessRights/OpenAccess |
en |
pubs.subtype |
Journal Article |
|
pubs.subtype |
Observational Study |
|
pubs.elements-id |
1012111 |
|
pubs.org-id |
Medical and Health Sciences |
|
pubs.org-id |
Science |
|
pubs.org-id |
Statistics |
|
pubs.org-id |
Population Health |
|
pubs.org-id |
Gen.Practice& Primary Hlthcare |
|
dc.identifier.eissn |
1873-2518 |
|
dc.identifier.pii |
S0264-410X(24)00127-0 |
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pubs.record-created-at-source-date |
2024-05-01 |
|
pubs.online-publication-date |
2024-02-12 |
|