Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults
An adjuvanted vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older adults has recently become available. Post-authorization safety studies (PASSs) conducted under real-world conditions complement data obtained from clinical trials characterized by s...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Vaccine: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590136225000415 |
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| author | Alexander Domnich Andrea Orsi Piero Luigi Lai Elvira Massaro Carlo-Simone Trombetta Julieta Pastorino Charlott Roihl Sara Tardito Marianna Pianta Giancarlo Icardi Donatella Panatto |
| author_facet | Alexander Domnich Andrea Orsi Piero Luigi Lai Elvira Massaro Carlo-Simone Trombetta Julieta Pastorino Charlott Roihl Sara Tardito Marianna Pianta Giancarlo Icardi Donatella Panatto |
| author_sort | Alexander Domnich |
| collection | DOAJ |
| description | An adjuvanted vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older adults has recently become available. Post-authorization safety studies (PASSs) conducted under real-world conditions complement data obtained from clinical trials characterized by stringent eligibility criteria. The aim of this PASS study was to evaluate reactogenicity and safety of the novel RSVPreF3 OA, which is currently not included in the Italian immunization schedule. In 2024, adult individuals aged ≥60 years were invited to get vaccinated with a single dose of RSVPreF3 OA. Following vaccination, they were instructed to fill in a diary on the occurrence, grade and duration of local and systemic adverse events (AEs) during the first week post-vaccination. They were also encouraged to notify any other events occurring at any time post-vaccination. The exposure set included 453 adults. Of these, 398 individuals returned valid diaries. At least one solicited AE (generally lasted 1–3 days) was reported by 70.6 % (95 % CI: 65.9–75.0 %) of vaccinees. Injection-site pain was the far most prevalent (60.1 %; 95 % CI: 55.1–64.9 %) solicited AE. Among systemic AEs, malaise/fatigue, headache, arthralgia and myalgia occurred in >10 % of vaccinees, while fever was rare (0.3 %; 95 % CI: 0–1.4 %). Grade 3 severe AEs were registered in 3.5 % (95 % CI: 1.9–5.8 %) of vaccinees. Older age was associated with a lower likelihood of reporting AEs. During a median follow-up of 211 days, no unsolicited serious AEs were registered. This PASS study confirmed an acceptable safety and reactogenicity profiles of RSVPreF3 OA. |
| format | Article |
| id | doaj-art-b925ede81ec34752bf3aa2b30effec56 |
| institution | Kabale University |
| issn | 2590-1362 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Vaccine: X |
| spelling | doaj-art-b925ede81ec34752bf3aa2b30effec562025-08-20T03:25:05ZengElsevierVaccine: X2590-13622025-06-012410064710.1016/j.jvacx.2025.100647Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adultsAlexander Domnich0Andrea Orsi1Piero Luigi Lai2Elvira Massaro3Carlo-Simone Trombetta4Julieta Pastorino5Charlott Roihl6Sara Tardito7Marianna Pianta8Giancarlo Icardi9Donatella Panatto10Hygiene Unit, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genoa, ItalyHygiene Unit, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy; Interuniversity Research Centre on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, Italy; Interuniversity Research Centre on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, ItalyHygiene Unit, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy; Interuniversity Research Centre on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, ItalyDepartment of Health Sciences, University of Genoa, Genoa, Italy; Interuniversity Research Centre on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy; Corresponding author at: Hygiene Unit, Department of Health Sciences, University of Genoa, Via Pastore 1, 16132 Genoa, Italy.An adjuvanted vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older adults has recently become available. Post-authorization safety studies (PASSs) conducted under real-world conditions complement data obtained from clinical trials characterized by stringent eligibility criteria. The aim of this PASS study was to evaluate reactogenicity and safety of the novel RSVPreF3 OA, which is currently not included in the Italian immunization schedule. In 2024, adult individuals aged ≥60 years were invited to get vaccinated with a single dose of RSVPreF3 OA. Following vaccination, they were instructed to fill in a diary on the occurrence, grade and duration of local and systemic adverse events (AEs) during the first week post-vaccination. They were also encouraged to notify any other events occurring at any time post-vaccination. The exposure set included 453 adults. Of these, 398 individuals returned valid diaries. At least one solicited AE (generally lasted 1–3 days) was reported by 70.6 % (95 % CI: 65.9–75.0 %) of vaccinees. Injection-site pain was the far most prevalent (60.1 %; 95 % CI: 55.1–64.9 %) solicited AE. Among systemic AEs, malaise/fatigue, headache, arthralgia and myalgia occurred in >10 % of vaccinees, while fever was rare (0.3 %; 95 % CI: 0–1.4 %). Grade 3 severe AEs were registered in 3.5 % (95 % CI: 1.9–5.8 %) of vaccinees. Older age was associated with a lower likelihood of reporting AEs. During a median follow-up of 211 days, no unsolicited serious AEs were registered. This PASS study confirmed an acceptable safety and reactogenicity profiles of RSVPreF3 OA.http://www.sciencedirect.com/science/article/pii/S2590136225000415Respiratory syncytial virusRSVRSV vaccineArexvySafetyElderly |
| spellingShingle | Alexander Domnich Andrea Orsi Piero Luigi Lai Elvira Massaro Carlo-Simone Trombetta Julieta Pastorino Charlott Roihl Sara Tardito Marianna Pianta Giancarlo Icardi Donatella Panatto Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults Vaccine: X Respiratory syncytial virus RSV RSV vaccine Arexvy Safety Elderly |
| title | Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults |
| title_full | Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults |
| title_fullStr | Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults |
| title_full_unstemmed | Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults |
| title_short | Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults |
| title_sort | enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among italian older adults |
| topic | Respiratory syncytial virus RSV RSV vaccine Arexvy Safety Elderly |
| url | http://www.sciencedirect.com/science/article/pii/S2590136225000415 |
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