COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

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...

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Published in:Vaccine 2024-04, Vol.42 (9), p.2200-2211
Main Authors: Faksova, K., Walsh, D., Jiang, Y., Griffin, J., Phillips, A., Gentile, A., Kwong, J.C., Macartney, K., Naus, M., Grange, Z., Escolano, S., Sepulveda, G., Shetty, A., Pillsbury, A., Sullivan, C., Naveed, Z., Janjua, N.Z., Giglio, N., Perälä, J., Nasreen, S., Gidding, H., Hovi, P., Vo, T., Cui, F., Deng, L., Cullen, L., Artama, M., Lu, H., Clothier, H.J., Batty, K., Paynter, J., Petousis-Harris, H., Buttery, J., Black, S., Hviid, A.
Format: Article
Language:English
Subjects:
2019-nCoV Vaccine mRNA-1273
Adverse events
Adverse events following immunization
Adverse events of special interest
Biochemistry, Molecular Biology
BNT162 Vaccine
Cohort analysis
Cohort Studies
Collaboration
COVID-19
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Drug dosages
Emergency medical care
Encephalomyelitis
Female
Guillain-Barre syndrome
Guillain-Barre Syndrome - chemically induced
Guillain-Barre Syndrome - epidemiology
Health care
Heart diseases
Humans
Immunization
Life Sciences
Lower bounds
Male
mRNA
mRNA Vaccines
Myocarditis
Observational studies
Observed vs. expected analysis
Pericarditis
Pharmacovigilance
Ratios
Safety
Sinus Thrombosis, Intracranial
Thrombocytopenia
Thromboembolism
Thrombosis
Vaccination - adverse effects
Vaccine safety surveillance
Vaccines
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Summary: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. 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. 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. 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.
ISSN:0264-410X
1873-2518
0264-410X
DOI:10.1016/j.vaccine.2024.01.100