Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis
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Background rates of adverse events of special interest for COVID-19 vaccines : A multinational Global Vaccine Data Network (GVDN) analysis. / Phillips, A.; Jiang, Y.; Walsh, D.; Andrews, N.; Artama, M.; Clothier, H.; Cullen, L.; Deng, L.; Escolano, S.; Gentile, A.; Gidding, G.; Giglio, N.; Junker, T.; Huang, W.; Janjua, N.; Kwong, J.; Li, J.; Nasreen, S.; Naus, M.; Naveed, Z.; Pillsbury, A.; Stowe, J.; Vo, T.; Buttery, J.; Petousis-Harris, H.; Black, S.; Hviid, A.
In: Vaccine, Vol. 41, No. 42, 2023, p. 6227-6238.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Background rates of adverse events of special interest for COVID-19 vaccines
T2 - A multinational Global Vaccine Data Network (GVDN) analysis
AU - Phillips, A.
AU - Jiang, Y.
AU - Walsh, D.
AU - Andrews, N.
AU - Artama, M.
AU - Clothier, H.
AU - Cullen, L.
AU - Deng, L.
AU - Escolano, S.
AU - Gentile, A.
AU - Gidding, G.
AU - Giglio, N.
AU - Junker, T.
AU - Huang, W.
AU - Janjua, N.
AU - Kwong, J.
AU - Li, J.
AU - Nasreen, S.
AU - Naus, M.
AU - Naveed, Z.
AU - Pillsbury, A.
AU - Stowe, J.
AU - Vo, T.
AU - Buttery, J.
AU - Petousis-Harris, H.
AU - Black, S.
AU - Hviid, A.
N1 - Publisher Copyright: © 2023
PY - 2023
Y1 - 2023
N2 - Background: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. Results: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Conclusion: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.
AB - Background: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. Results: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Conclusion: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.
KW - Adverse event following immunization
KW - Background rates
KW - COVID-19
KW - Pharmacovigilance
KW - Vaccine safety surveillance
U2 - 10.1016/j.vaccine.2023.08.079
DO - 10.1016/j.vaccine.2023.08.079
M3 - Journal article
C2 - 37673715
AN - SCOPUS:85170415673
VL - 41
SP - 6227
EP - 6238
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 42
ER -
ID: 368336507