Vaccine · 2024
Participant-reported neurological events following immunization in the Canadian National Vaccine Safety Network-COVID-19 vaccine (CANVAS-COVID) study.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Top Karina A, Shulha Hennady P, Muller Matthew P, Valiquette Louis, Vanderkooi Otto G, Kellner James D, Sadarangani Manish, Irvine Michael A, McGeer Allison, Isenor Jennifer E, Marty Kimberly, Soe Phyumar, De Serres Gaston, Bettinger Julie A, Canadian Immunization Research Network Investigators
Аннотация
INTRODUCTION: The Canadian National Vaccine Safety Network (CANVAS) conducted active participant-based surveillance for adverse events following immunization during the COVID-19 vaccine campaign. This study evaluated the association between COVID-19 vaccination and neurological adverse events.
METHODS: Participants were invited to complete online surveys to report health events that prevented daily activities and/or required medical attention within 7 days after COVID-19 vaccination or 7 days prior to the survey (unvaccinated controls); follow-up surveys were sent 7 months later. Neurological events were health events where the most severe symptom reported was ≥1 of: numbness/tingling, loss of taste or smell, vision loss, facial weakness/paralysis, seizure, weakness/paralysis of arms or legs, confusion, change in personality or behavior, or difficulty with urination or defecation. Data were extracted from the CANVAS-COVID database for analysis.
RESULTS: Completed survey responses were received from 15,273 unvaccinated controls, 758,619 dose 1 recipients, 406,884 dose 2 recipients, and 126,586 dose 3 recipients. Rates of neurological events ranged from 15.9 (95 % CI 13.6-18.4) per 10,000 dose 1 ChAdOx1 recipients to 8.4 (6.5-10.8) and 7.9 (5.7-11.0) per 10,000 dose 3 mRNA-1273 and BNT162b2 recipients, respectively. Multivariable regression adjusted for age, sex, previous SARS-CoV-2 infection, and baseline health status showed an increased risk of neurological event among ChAdOx1 dose 1 recipients versus controls (adjusted OR 2.3, 95 % CI 1.2-4.3), but not among mRNA vaccine recipients after any dose. Risk of anaesthesia/paresthesia were increased following ChAdOx1 dose 1 (aOR 4.7, 1.7-13.1), and consistently but not statistically significantly higher following any dose of either mRNA vaccine. Risk of loss of smell/taste was decreased among recipients of any dose of either mRNA vaccine versus controls.
CONCLUSIONS: The results support the safety of COVID-19 vaccines while confirming reported associations between ChAdOx1 dose 1 and neurological events. Participant-based AEFI surveillance is a useful component of post-market surveillance programs.
METHODS: Participants were invited to complete online surveys to report health events that prevented daily activities and/or required medical attention within 7 days after COVID-19 vaccination or 7 days prior to the survey (unvaccinated controls); follow-up surveys were sent 7 months later. Neurological events were health events where the most severe symptom reported was ≥1 of: numbness/tingling, loss of taste or smell, vision loss, facial weakness/paralysis, seizure, weakness/paralysis of arms or legs, confusion, change in personality or behavior, or difficulty with urination or defecation. Data were extracted from the CANVAS-COVID database for analysis.
RESULTS: Completed survey responses were received from 15,273 unvaccinated controls, 758,619 dose 1 recipients, 406,884 dose 2 recipients, and 126,586 dose 3 recipients. Rates of neurological events ranged from 15.9 (95 % CI 13.6-18.4) per 10,000 dose 1 ChAdOx1 recipients to 8.4 (6.5-10.8) and 7.9 (5.7-11.0) per 10,000 dose 3 mRNA-1273 and BNT162b2 recipients, respectively. Multivariable regression adjusted for age, sex, previous SARS-CoV-2 infection, and baseline health status showed an increased risk of neurological event among ChAdOx1 dose 1 recipients versus controls (adjusted OR 2.3, 95 % CI 1.2-4.3), but not among mRNA vaccine recipients after any dose. Risk of anaesthesia/paresthesia were increased following ChAdOx1 dose 1 (aOR 4.7, 1.7-13.1), and consistently but not statistically significantly higher following any dose of either mRNA vaccine. Risk of loss of smell/taste was decreased among recipients of any dose of either mRNA vaccine versus controls.
CONCLUSIONS: The results support the safety of COVID-19 vaccines while confirming reported associations between ChAdOx1 dose 1 and neurological events. Participant-based AEFI surveillance is a useful component of post-market surveillance programs.