| アブストラクト | BACKGROUND: Myocarditis and pericarditis have been associated most notably with mRNA vaccines, but the association with a recently authorized adjuvated vaccine (NVX-CoV2373) is controversial. OBJECTIVE: The aim was to analyze the cases of myocarditis and pericarditis in association with NVX-CoV2373 reported to the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase), applying disproportionality analyses. PATIENTS AND METHODS: The main characteristics of the ICSRs reporting myopericarditis with NVX-CoV2373 have been summarized. Reporting odds ratios (RORs) as a measure of disproportionality for reported myopericarditis (November 1967-August 2022) have been calculated for NVX-CoV2373; mRNA and adenoviral vector-based vaccines were also included as a reference. RESULTS: In total, 61 ICSRs included NVX-CoV2373. Most of the reports originated in Australia (50; 82.0%); 24 (39.3%) were considered serious. None of them were fatal. The median age of individuals was 35.5 years old, and most were males (38; 62.3%). Chest pain was the most common co-reported event 43 (70.5%). The median induction period was 3 days after immunization. Increased disproportionality for myopericarditis was found for NVX-CoV2373 (ROR 14.47, 95% confidence interval [CI] 11.22-18.67) and mRNA vaccines: BNT162b2 (ROR 17.15, 95% CI 16.88-17.42) and mRNA-1273 (ROR 6.92, 95% CI 6.77-7.08). Higher values were found in males. The adenoviral vector-based vaccine Ad26.COV2.S showed slightly increased disproportionality (ROR 1.83, 95% CI 1.70-1.98), whereas no increased disproportionality was found for ChAdOx1. CONCLUSIONS: NVX-CoV2373 vaccine showed a similar increased disproportionality as mRNA vaccines. More evidence from controlled studies is necessary; however, a precautionary approach is warranted. Healthcare professionals should be aware of the potential occurrence of myopericarditis with this new vaccine. |
|---|
| ジャーナル名 | Drugs - real world outcomes |
|---|
| 投稿日 | 2023/2/15 |
|---|
| 投稿者 | Macias Saint-Gerons, Diego; Ibarz, Maria Teresa; Castro, Jose Luis; Fores-Martos, Jaume; Tabares-Seisdedos, Rafael |
|---|
| 組織名 | Department of Medicine, University of Valencia/INCLIVA Health Research Institute;and CIBERSAM, Valencia, Spain. dmacias.sg@gmail.com.;Faculty of Pharmacy, Central University of Venezuela, Caracas, Venezuela.;Fundacion para la Innovacion, Investigacion, Formacion y el Desarrollo;Comunitario (FUNDEC), Santa Cruz de Tenerife, Spain.;and CIBERSAM, Valencia, Spain.;Department of Mathematics, Physics and Technological Sciences, Universidad;Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36788170/ |
|---|
