| アブストラクト | On November 4, 2019, the Food and Drug Administration approved high-dose quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent; QIV-HD) for active immunization for the prevention of influenza disease in individuals 65 years of age and older. A prelicensure randomized, active-controlled, modified double-blind trial did not reveal any major differences in adverse events following QIV-HD versus Fluzone High-Dose (trivalent). To improve our understanding of the safety profile of QIV-HD, we reviewed and summarized reports of adverse events after QIV-HD to the Vaccine Adverse Event Reporting System (VAERS). From July 30, 2020 through June 30, 2021, VAERS received 2,122 reports after QIV-HD. The vast majority (2,018; 95.1%) were non-serious and included events that had been observed in the prelicensure clinical trial, such as injection site reactions, fever, headache, and nausea. The most common serious events included Guillain-Barre syndrome, cellulitis or other local reactions, constitutional signs/symptoms (e.g., fever), and cardiovascular events. Our review did not reveal any new safety concerns. This information may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies. |
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| 組織名 | Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and;Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver;Spring, MD 20903, United States. Electronic address: jane.woo@fda.hhs.gov.;Immunization Safety Office, Division of Healthcare Quality Promotion, National;Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control;and Prevention, Atlanta, Georgia. Electronic address: pedro.moro@cdc.hhs.gov. |
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