ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1682119
This article is part of the Research TopicBiologic Drugs for immune-mediated inflammatory diseases (IMIDs) and Vaccines for infections: Validation, Drug-Utilization, Effectiveness, Regulation, Costs, and Safety in the real worldView all 5 articles
Real-world Feasibility of Co-administration of RSV, COVID-19, and Influenza Vaccines in Older Adults: A VAERS-based Analysis
Provisionally accepted- 1Shandong University of Traditional Chinese Medicine, Jinan, China
- 2Tengzhou Central People's Hospital, Shandong, China
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Background: Respiratory syncytial virus (RSV), COVID-19, and seasonal influenza are significant health threats to older adults and often co-circulate. Co-administering these vaccines could improve coverage and convenience, but real-world safety data for adults aged 60+ are limited. Objective: This study explored the safety profile of co-administered RSV, COVID-19, and influenza vaccines in older adults, using U.S. VAERS data to identify potential adverse event (AEFI) patterns and generate safety hypotheses. Methods: AEFI reports for adults ≥60 years from May 3, 2023, to January 1, 2025, were analyzed. Three cohorts were defined: RSV–COVID-19, RSV–influenza, and triple vaccination. Four disproportionality analyses (ROR, PRR, BCPNN, MGPS) were used to detect potential safety signals. Results: There were 479, 576, and 194 AEFI reports in the RSV–COVID-19, RSV–influenza, and triple-vaccination groups, respectively. Most reporters were female. Over 96% of AEFIs occurred within 30 days post-vaccination, and non-serious AEFIs accounted for 85.6%–88.5%. Common AEFIs included general disorders and nervous system disorders. Potential safety signals included ear/labyrinth disorders, skin disorders, and injury-related complications. At the Preferred Term level, commonly reported AEFIs were headache and fatigue, while signals such as aphasia and gait disturbance emerged. Serious reports revealed signals like cerebrovascular accidents and muscular weakness. Conclusions: The safety profile of co-administered RSV, COVID-19, and influenza vaccines in older adults is generally favorable, with most AEFIs being mild and self-limiting. These findings are hypothesis-generating and do not prove causation. Potential signals of rare but serious neurological or cardiovascular events require further investigation in robust observational studies.
Keywords: RSV and COVID-19 co-administration group, RSV and seasonal influenza co-administration group, triple vaccination group, VAERS, Adverse events following immunization
Received: 08 Aug 2025; Accepted: 09 Oct 2025.
Copyright: © 2025 Wei and Yu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Shilun Yu, 1416565558@qq.com
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