Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink.
JAMA Netw Open
; 5(4): e228879, 2022 04 01.
Article
in English
| MEDLINE | ID: covidwho-1801993
ABSTRACT
Importance Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100â¯000 person-years. Objective:
To describe cases and incidence of GBS following COVID-19 vaccination and assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design, Setting, andParticipants:
This cohort study used surveillance data from the Vaccine Safety Datalink at 8 participating integrated health care systems in the United States. There were 10â¯158â¯003 participants aged at least 12 years. Data analysis was performed from November 2021 to February 2022. Exposures Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine, including mRNA vaccine doses 1 and 2, December 13, 2020, to November 13, 2021. Main Outcomes andMeasures:
GBS with symptom onset in the 1 to 84 days after vaccination, confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared with the background rate, rate ratios (RRs) comparing GBS incidence in the 1 to 21 vs 22 to 42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs mRNA vaccination, using Poisson regression adjusted for age, sex, race and ethnicity, site, and calendar day.Results:
From December 13, 2020, through November 13, 2021, 15â¯120â¯073 doses of COVID-19 vaccines were administered to 7â¯894â¯989 individuals (mean [SE] age, 46.5 [0.02] years; 8â¯138â¯318 doses received [53.8%] by female individuals; 3â¯671â¯199 doses received [24.3%] by Hispanic or Latino individuals, 2â¯215â¯064 doses received [14.7%] by Asian individuals, 6â¯266â¯424 doses received [41.4%] by White individuals), including 483â¯053 Ad.26.COV2.S doses, 8â¯806â¯595 BNT162b2 doses, and 5â¯830â¯425 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of GBS per 100â¯000 person-years in the 1 to 21 days after Ad.26.COV2.S was 32.4 (95% CI, 14.8-61.5), significantly higher than the background rate, and the adjusted RR in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S was 6.03 (95% CI, 0.79-147.79). Thirty-six cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate per 100â¯000 person-years in the 1 to 21 days after mRNA vaccines was 1.3 (95% CI, 0.7-2.4) and the adjusted RR in the 1 to 21 vs 22 to 42 days following mRNA vaccines was 0.56 (95% CI, 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs mRNA vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66). Conclusions and Relevance In this cohort study of COVID-19 vaccines, the incidence of GBS was elevated after receiving the Ad.26.COV2.S vaccine. Surveillance is ongoing.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Guillain-Barre Syndrome
/
COVID-19
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Female
/
Humans
/
Middle aged
Country/Region as subject:
North America
Language:
English
Journal:
JAMA Netw Open
Year:
2022
Document Type:
Article
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