AI Article Synopsis
- A study was conducted to monitor rare adverse events, specifically Guillain-Barré syndrome (GBS), following COVID-19 vaccinations in a large population, as these events may not show up in clinical trials.
- The research utilized data from over 10 million participants across multiple healthcare systems in the U.S. to analyze the incidence of GBS after vaccination with different types of COVID-19 vaccines, including the Janssen and mRNA vaccines.
- The results indicated that there were cases of GBS reported in the time frame following vaccination, prompting a comparison of incidence rates between the vaccine types and a background rate of GBS occurrence in the general population.
Article 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 100 000 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, And Participants: This cohort study used surveillance data from the Vaccine Safety Datalink at 8 participating integrated health care systems in the United States. There were 10 158 003 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 And Measures: 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, 15 120 073 doses of COVID-19 vaccines were administered to 7 894 989 individuals (mean [SE] age, 46.5 [0.02] years; 8 138 318 doses received [53.8%] by female individuals; 3 671 199 doses received [24.3%] by Hispanic or Latino individuals, 2 215 064 doses received [14.7%] by Asian individuals, 6 266 424 doses received [41.4%] by White individuals), including 483 053 Ad.26.COV2.S doses, 8 806 595 BNT162b2 doses, and 5 830 425 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of GBS per 100 000 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 100 000 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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9044108 | PMC |
| http://dx.doi.org/10.1001/jamanetworkopen.2022.8879 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Psilocybin-assisted massed cognitive processing therapy for chronic posttraumatic stress disorder: Protocol for an open-label pilot feasibility trial.
PLoS One
January 2025
Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada.
Background: Posttraumatic stress disorder (PTSD) affects 3.9% of the general population. While massed cognitive processing therapy (CPT) has demonstrated efficacy in treating chronic PTSD, a substantial proportion of patients still continue to meet PTSD criteria after treatment, highlighting the need for novel therapeutic approaches.
View Article and Find Full Text PDFA study of association between maternal tetanus toxoid immunization and neonatal mortality in the context of Bangladesh.
PLoS One
January 2025
Department of Statistics, Shahjalal University of Science & Technology, Sylhet, Bangladesh.
Background: Maternal tetanus toxoid (MTT) vaccination during pregnancy remains an important factor for reducing infant mortality globally, especially in developing nations, including Bangladesh. Despite commendable progress in reducing child mortality through widespread MTT vaccination during pregnancy, the issue still exists. This analysis explores the impact of MTT vaccination on neonatal mortality in Bangladesh and identifies associated factors.
View Article and Find Full Text PDFMaralixibat Reduces Serum Bile Acids and Improves Cholestatic Pruritus in Adolescents With Alagille Syndrome.
Liver Int
February 2025
Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children and the University of Toronto, Toronto, Ontario, Canada.
Background: Alagille syndrome (ALGS) is a multisystem cholestatic disorder. Maralixibat is approved for the treatment of cholestatic pruritus in ALGS with limited data in adults.
Methods: Participants were included if they received ≥ 2 doses of maralixibat at age ≥ 16 years in one of the three previously published maralixibat ALGS clinical trials.
The Second Round of a Population-Based Seroprevalence Study of Anti-SARS-CoV-2 Antibodies and COVID-19 Vaccination Assessment in the Republika Srpska, Bosnia and Herzegovina.
Influenza Other Respir Viruses
January 2025
Centre for Biomedical Research, Faculty of Medicine, University of Banja Luka, Banja Luka, Republika Srpska, Bosnia and Herzegovina.
Introduction: The aim of the study was to assess the seroprevalence of SARS-CoV-2 in the Republika Srpska, Bosnia and Herzegovina, after five waves of COVID-19 and 1 year after introduction of vaccination to better understand the true extent of the COVID-19 pandemic in the population of the Republika Srpska and role of vaccination in achieving herd immunity.
Methods: The population-based study was conducted from December 2021 to February 2022 in a group of 4463 individuals in the Republika Srpska. Total anti-SARS-CoV-2 antibodies were determined in serum specimens using the Wantai total antibody ELISA assay.
Preemptive hydromorphone analgesia reduces postoperative delirium and stress response in laparoscopic cholecystectomy patients.
Am J Transl Res
December 2024
Department of Anesthesiology, Xi'an Central Hospital No. 161, Xiwu Road, Xincheng District, Xi'an 710003, Shaanxi, China.
Objective: To evaluate the effects of preemptive hydromorphone analgesia on postoperative delirium and stress response in patients undergoing laparoscopic cholecystectomy.
Methods: A retrospective cohort study was conducted, including 167 patients who underwent laparoscopic cholecystectomy at Xi'an Central Hospital between June 2021 and November 2023. Patients were categorized into an observation group (n=87) receiving preemptive hydromorphone hydrochloride analgesia and a control group (n=80) without preemptive analgesia.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!