Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season
Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023–24 season. The primary objective was to evaluate adverse drug...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2475616 |
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| author | Marina Amaral de Avila Machado Sophie Gallo Alexander Goldstein Parth Vachhani Reddappa Maniganahally Byrareddy Anu Kantele Hanna Välimaa Jörg Schelling |
| author_facet | Marina Amaral de Avila Machado Sophie Gallo Alexander Goldstein Parth Vachhani Reddappa Maniganahally Byrareddy Anu Kantele Hanna Välimaa Jörg Schelling |
| author_sort | Marina Amaral de Avila Machado |
| collection | DOAJ |
| description | Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023–24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023–24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4. |
| format | Article |
| id | doaj-art-2e98f7bd124c448c97aecbf371c6463b |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-2e98f7bd124c448c97aecbf371c6463b2025-08-20T02:56:24ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2475616Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 seasonMarina Amaral de Avila Machado0Sophie Gallo1Alexander Goldstein2Parth Vachhani3Reddappa Maniganahally Byrareddy4Anu Kantele5Hanna Välimaa6Jörg Schelling7Epidemiology & Benefit-Risk, Sanofi, Toronto, CanadaMedical Operations, Sanofi, Lyon, FrancePatient Safety & Pharmacovigilance, Sanofi, Moscow, RussiaPatient Safety & Pharmacovigilance, Sanofi, Bengaluru, IndiaPatient Safety & Pharmacovigilance, Sanofi, Bengaluru, IndiaMeilahti Vaccine Research Center MeVac, Helsinki University Hospital and University of Helsinki, Helsinki, FinlandMeilahti Vaccine Research Center MeVac, Helsinki University Hospital and University of Helsinki, Helsinki, FinlandHausärztliche Gemeinschaftspraxis Martinsried, Martinsried, GermanyEnhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023–24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023–24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.https://www.tandfonline.com/doi/10.1080/21645515.2025.2475616EflueldaVaxigrip Tetrainfluenza vaccinequadrivalent split-virion inactivated influenza vaccineadverse drug reactionsenhanced safety surveillance |
| spellingShingle | Marina Amaral de Avila Machado Sophie Gallo Alexander Goldstein Parth Vachhani Reddappa Maniganahally Byrareddy Anu Kantele Hanna Välimaa Jörg Schelling Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season Human Vaccines & Immunotherapeutics Efluelda Vaxigrip Tetra influenza vaccine quadrivalent split-virion inactivated influenza vaccine adverse drug reactions enhanced safety surveillance |
| title | Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season |
| title_full | Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season |
| title_fullStr | Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season |
| title_full_unstemmed | Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season |
| title_short | Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season |
| title_sort | enhanced passive safety surveillance of standard dose and high dose influenza vaccines in finland and germany 2023 24 season |
| topic | Efluelda Vaxigrip Tetra influenza vaccine quadrivalent split-virion inactivated influenza vaccine adverse drug reactions enhanced safety surveillance |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2475616 |
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