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

K. Faksova; D. Walsh; Y. Jiang; J. Griffin; A. Phillips; A. Gentile; J. C. Kwong; K. Macartney; M. Naus; Z. Grange; S. Escolano; G. Sepulveda; A. Shetty; A. Pillsbury; C. Sullivan; Z. Naveed; N. Z. Janjua; N. Giglio; J. Perälä; S. Nasreen; H. Gidding; P. Hovi; T. Vo; F. Cui; L. Deng; L. Cullen; M. Artama; E. Weintraub; H. Lu; H. J. Clothier; K. Batty; J. Paynter; H. Petousis-Harris; J. Buttery; S. Black; A. Hviid

doi:10.1016/j.vaccine.2024.01.100

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

K. Faksova, D. Walsh, Y. Jiang, J. Griffin, A. Phillips, A. Gentile, J. C. Kwong, K. Macartney, M. Naus, Z. Grange, S. Escolano, G. Sepulveda, A. Shetty, A. Pillsbury, C. Sullivan, Z. Naveed, N. Z. Janjua, N. Giglio, J. Perälä, S. NasreenH. Gidding, P. Hovi, T. Vo, F. Cui, L. Deng, L. Cullen, M. Artama, E. Weintraub, H. Lu, H. J. Clothier, K. Batty, J. Paynter, H. Petousis-Harris, J. Buttery, S. Black, A. Hviid

Health Sciences

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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 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.

Original language	English
Pages (from-to)	2200-2211
Number of pages	12
Journal	VACCINE
Volume	42
Issue number	9
DOIs	https://doi.org/10.1016/j.vaccine.2024.01.100
Publication status	Published - 2024
Publication type	A1 Journal article-refereed

Keywords

Adverse events following immunization
Adverse events of special interest
COVID-19
Observed vs. expected analysis
Pharmacovigilance
Vaccine safety surveillance

Publication forum classification

Publication forum level 1

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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1-s2.0-S0264410X24001270-mainFinal published version, 3.49 MBLicence: CC BY

https://urn.fi/URN:NBN:fi:tuni-202404173699Licence: CC BY

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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., ... Hviid, A. (2024). COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals. VACCINE, 42(9), 2200-2211. https://doi.org/10.1016/j.vaccine.2024.01.100

@article{37189b6f63af40a6b71527190dc53703,

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

abstract = "Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network{\texttrademark} (GVDN{\textregistered}), 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-Barr{\'e} 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 analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barr{\'e} syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.",

keywords = "Adverse events following immunization, Adverse events of special interest, COVID-19, Observed vs. expected analysis, Pharmacovigilance, Vaccine safety surveillance",

author = "K. Faksova and D. Walsh and Y. Jiang and J. Griffin and A. Phillips and A. Gentile and Kwong, {J. C.} and K. Macartney and M. Naus and Z. Grange and S. Escolano and G. Sepulveda and A. Shetty and A. Pillsbury and C. Sullivan and Z. Naveed and Janjua, {N. Z.} and N. Giglio and J. Per{\"a}l{\"a} and S. Nasreen and H. Gidding and P. Hovi and T. Vo and F. Cui and L. Deng and L. Cullen and M. Artama and E. Weintraub and H. Lu and Clothier, {H. J.} and K. Batty and J. Paynter and H. Petousis-Harris and J. Buttery and S. Black and A. Hviid",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s)",

year = "2024",

doi = "10.1016/j.vaccine.2024.01.100",

language = "English",

volume = "42",

pages = "2200--2211",

journal = "VACCINE",

issn = "0264-410X",

publisher = "Elsevier",

number = "9",

}

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, Perälä, J, Nasreen, S, Gidding, H, Hovi, P, Vo, T, Cui, F, Deng, L, Cullen, L, Artama, M, Weintraub, E, Lu, H, Clothier, HJ, Batty, K, Paynter, J, Petousis-Harris, H, Buttery, J, Black, S & Hviid, A 2024, 'COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals', VACCINE, vol. 42, no. 9, pp. 2200-2211. https://doi.org/10.1016/j.vaccine.2024.01.100

TY - JOUR

T1 - COVID-19 vaccines and adverse events of special interest

T2 - A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

AU - Faksova, K.

AU - Walsh, D.

AU - Jiang, Y.

AU - Griffin, J.

AU - Phillips, A.

AU - Gentile, A.

AU - Kwong, J. C.

AU - Macartney, K.

AU - Naus, M.

AU - Grange, Z.

AU - Escolano, S.

AU - Sepulveda, G.

AU - Shetty, A.

AU - Pillsbury, A.

AU - Sullivan, C.

AU - Naveed, Z.

AU - Janjua, N. Z.

AU - Giglio, N.

AU - Perälä, J.

AU - Nasreen, S.

AU - Gidding, H.

AU - Hovi, P.

AU - Vo, T.

AU - Cui, F.

AU - Deng, L.

AU - Cullen, L.

AU - Artama, M.

AU - Weintraub, E.

AU - Lu, H.

AU - Clothier, H. J.

AU - Batty, K.

AU - Paynter, J.

AU - Petousis-Harris, H.

AU - Buttery, J.

AU - Black, S.

AU - Hviid, A.

PY - 2024

Y1 - 2024

N2 - 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 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.

AB - 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 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.

KW - Adverse events following immunization

KW - Adverse events of special interest

KW - COVID-19

KW - Observed vs. expected analysis

KW - Pharmacovigilance

KW - Vaccine safety surveillance

U2 - 10.1016/j.vaccine.2024.01.100

DO - 10.1016/j.vaccine.2024.01.100

M3 - Article

C2 - 38350768

AN - SCOPUS:85187300139

SN - 0264-410X

VL - 42

SP - 2200

EP - 2211

JO - VACCINE

JF - VACCINE

IS - 9

ER -

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

Abstract

Keywords

Publication forum classification

ASJC Scopus subject areas

UN SDGs

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