Observational Study
. 2024 Apr 2;42(9):2200-2211.
doi: 10.1016/j.vaccine.2024.01.100.
Epub 2024 Feb 12.
K Faksova
1
, D Walsh
2
, Y Jiang
2
, J Griffin
3
, A Phillips
4
, A Gentile
5
, J C Kwong
6
, K Macartney
7
, M Naus
8
, Z Grange
9
, S Escolano
10
, G Sepulveda
11
, A Shetty
11
, A Pillsbury
4
, C Sullivan
9
, Z Naveed
8
, N Z Janjua
8
, N Giglio
5
, J Perälä
12
, S Nasreen
13
, H Gidding
7
, P Hovi
14
, T Vo
15
, F Cui
16
, L Deng
4
, L Cullen
9
, M Artama
15
, H Lu
2
, H J Clothier
17
, K Batty
18
, J Paynter
19
, H Petousis-Harris
20
, J Buttery
21
, S Black
20
, A Hviid
22
Affiliations
-
PMID:
38350768
-
DOI:
Free article
Observational Study
K Faksova et al.
Vaccine.
.
Free article
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.
Keywords:
Adverse events following immunization; Adverse events of special interest; COVID-19; Observed vs. expected analysis; Pharmacovigilance; Vaccine safety surveillance.
Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jeffrey C. Kwong reports financial support was provided by Centers for Disease Control and Prevention. Naveed Z. Janjua reports financial support was provided by Centers for Disease Control and Prevention. Anders Hviid reports financial support was provided by Global Vaccine Data Network. Helen Petousis-Harris reports financial support was provided by New Zealand Ministry of Health. Steven Black reports a relationship with GSK that includes: consulting or advisory. Jeffrey C. Kwong reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Jeffrey C. Kwong reports a relationship with Public Health Agency of Canada that includes: funding grants. Naveed Z. Janjua reports a relationship with AbbVie Inc that includes: consulting or advisory and speaking and lecture fees. Naveed Z. Janjua reports a relationship with Gilead Sciences Inc that includes: speaking and lecture fees. Anders H
