RESUMO
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, 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 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 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, 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.
Assuntos
COVID-19 , Síndrome de Guillain-Barré , Vacina BNT162 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos de Coortes , Feminino , Síndrome de Guillain-Barré/epidemiologia , Síndrome de Guillain-Barré/etiologia , Humanos , Incidência , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Vacinação/efeitos adversos , Vacinas Sintéticas , Vacinas de mRNARESUMO
The epidemic emergence of Zika virus (ZIKV) in 2015-2016 has been associated with congenital malformations and neurological sequela. Current efforts to develop a ZIKV vaccine build on technologies that successfully reduced infection or disease burden against closely related flaviviruses or other RNA viruses. Subunit-based (DNA plasmid and modified mRNA), viral vectored (adeno- and measles viruses) and inactivated viral vaccines are already advancing to clinical trials in humans after successful mouse and non-human primate studies. Among the greatest challenges for the rapid implementation of immunogenic and protective ZIKV vaccines will be addressing the potential for exacerbating Dengue virus infection or causing Guillain-Barré syndrome through production of cross-reactive immunity targeting related viral or host proteins. Here, we review vaccine strategies under development for ZIKV and the issues surrounding their usage.
Assuntos
Vacinas de DNA/imunologia , Vacinas de DNA/isolamento & purificação , Vacinas Virais/imunologia , Vacinas Virais/isolamento & purificação , Infecção por Zika virus/prevenção & controle , Zika virus/imunologia , Animais , Ensaios Clínicos como Assunto , Dengue/epidemiologia , Avaliação Pré-Clínica de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Síndrome de Guillain-Barré/epidemiologia , Humanos , Camundongos , Vacinas de DNA/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Vacinas de Produtos Inativados/isolamento & purificação , Vacinas de Subunidades Antigênicas/efeitos adversos , Vacinas de Subunidades Antigênicas/imunologia , Vacinas de Subunidades Antigênicas/isolamento & purificação , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologia , Vacinas Sintéticas/isolamento & purificação , Vacinas Virais/efeitos adversosRESUMO
OBJECTIVE: The present study aimed to evaluate the characteristics of inpatient mortality from Guillain-Barré syndrome (GBS), which is a rare and potentially life-threatening polyradiculoneuropathy, in an Asian country, as there are few big-data studies regarding this topic. METHODS: We obtained data regarding patients with GBS from Taiwan's National Health Insurance Research Database admission records. We identified patients with a discharge diagnosis of GBS during 2000-2013 using the International Classification of Diseases, 9th Revision, Clinical Modification code (357.0), and evaluated their baseline characteristics, clinical complications, and risk factors. RESULTS: We identified 5469 patients with GBS, and the crude incidence of GBS was 1.71 per 100,000 person-years. The inpatient mortality rate was 1.61% (88/5469) and 55 deaths (62.5% of all deaths) occurred before day 19 of the hospitalization (mainly during the progressive phase). The predictors of inpatient mortality included older age, a greater comorbidity burden (especially catastrophic illness), endotracheal intubation, mechanical ventilation, cardiac complications, and systemic infection. In contrast, patients who were admitted to a medical center or Neurology Department exhibited a higher survival rate. CONCLUSIONS: This 14-year nationwide study included the largest analysis of Asian patients with GBS to date, and identified various prognostic factors that predicted inpatient mortality.