1. COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals
- Author
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Faksova, K, Walsh, D, Jiang, Y, Griffin, J, Phillips, A, Gentile, A, Kwong, JC, Macartney, K, Naus, M, Grange, Z, Escolano, S, Sepulveda, G, Shetty, A, Pillsbury, A, Sullivan, C, Naveed, Z, Janjua, NZ, Giglio, N, Perala, J, Nasreen, S, Gidding, H, Hovi, P, Vo, T, Cui, F, Deng, L, Cullen, L, Artama, M, Lu, H, Clothier, HJ, Batty, K, Paynter, J, Petousis-Harris, H, Buttery, J, Black, S, Hviid, A, Faksova, K, Walsh, D, Jiang, Y, Griffin, J, Phillips, A, Gentile, A, Kwong, JC, Macartney, K, Naus, M, Grange, Z, Escolano, S, Sepulveda, G, Shetty, A, Pillsbury, A, Sullivan, C, Naveed, Z, Janjua, NZ, Giglio, N, Perala, J, Nasreen, S, Gidding, H, Hovi, P, Vo, T, Cui, F, Deng, L, Cullen, L, Artama, M, Lu, H, Clothier, HJ, Batty, K, Paynter, J, Petousis-Harris, H, Buttery, J, Black, S, and Hviid, A
- Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: This multi-country a
- Published
- 2024