Enhanced passive safety surveillance of high‐dose and standard‐dose quadrivalent inactivated split‐virion influenza vaccines in Germany and Finland during the influenza season 2021/22

Gandhi-Banga, Sonja; Wagué, Sophie; Shrestha, Anju; Syrkina, Olga; Talanova, Oxana; Nissilä, M; Stuff, Karl; Monfredo, Céline

doi:10.1111/irv.13071

Cited by 6 publications

(15 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…No major safety signals were observed, in line with post‐marketing surveillance data of QIV [30]. The imbalance in cardiac deaths (CAD‐related deaths [a cardiac SOC] were higher with QIV‐HD, whereas arteriosclerosis‐related deaths [a vascular SOC]) were marginally higher with QIV‐SD) may be partially due to MedDRA SOC/PT coding of cardiovascular indications.…”

Section: Discussionsupporting

confidence: 56%

“…In mid-March 2020, Finland introduced extensive social restrictions, after which influenza circulation declined rapidly (Figure S6) [25,28]. Influenza vaccination was still anticipated to impact influenza circulation, since circulating influenza A and B strains in 2019-2020 corresponded to those in the QIV, and vaccine effectiveness estimates from a Finnish cohort study were high in children (68%-71%) and moderate in the elderly (29%) [29].…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

High‐Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults

Palmu,

Pepin,

Syrjänen

et al. 2024

Influenza Resp Viruses

View full text Add to dashboard Cite

BackgroundWe assessed the relative vaccine effectiveness (rVE) of high‐dose quadrivalent influenza vaccine (QIV‐HD) versus standard‐dose quadrivalent influenza vaccine (QIV‐SD) in preventing respiratory or cardiovascular hospitalizations in older adults.MethodsFinFluHD was a phase 3b/4 modified double‐blind, randomized pragmatic trial. Enrolment of 121,000 adults ≥65 years was planned over three influenza seasons (October to December 2019–2021). Participants received a single injection of QIV‐HD or QIV‐SD. The primary endpoint was first occurrence of an unscheduled acute respiratory or cardiovascular hospitalization (ICD‐10 primary discharge J/I codes), from ≥14 days post‐vaccination until May 31. The study was terminated after one season due to COVID‐19; follow‐up data for 2019–2020 are presented.Results33,093 participants were vaccinated (QIV‐HD, n = 16,549; QIV‐SD, n = 16,544); 529 respiratory or cardiovascular hospitalizations (QIV‐HD, n = 257; QIV‐SD, n = 272) were recorded. The rVE of QIV‐HD versus QIV‐SD to prevent respiratory/cardiovascular hospitalizations was 5.5% (95% CI, −12.4 to 20.7). When prevention of respiratory and cardiovascular hospitalizations were considered separately, rVE estimates of QIV‐HD versus QIV‐SD were 5.4% (95% CI, −28.0 to 30.1) and 7.1% (95% CI, −15.0 to 25.0), respectively. Serious adverse reactions were <0.01% in both groups.ConclusionsDespite insufficient statistical power due to the impact of COVID‐19, rVE point estimates demonstrated a trend toward a benefit of QIV‐HD over QIV‐SD. QIV‐HD was associated with lower respiratory or cardiovascular hospitalization rates than QIV‐SD, with a comparable safety profile. Adequately powered studies conducted over multiple influenza seasons are needed to determine statistical significance of QIV‐HD compared with QIV‐SD against preventing respiratory and cardiovascular hospitalizations.Trial Registration: ClinicalTrials.gov number: NCT04137887

show abstract

Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

High‐Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults

Palmu,

Pepin,

Syrjänen

et al. 2024

Influenza Resp Viruses

View full text Add to dashboard Cite

show abstract

“…This study design was derived from a previous EPSS study carried out in Germany and Finland during the 2021/22 influenza season. 7 …”

Section: Methodsmentioning

confidence: 99%

“…Based on EPSS studies of quadrivalent inactivated influenza vaccine (IIV4) over several seasons in Finland, web-based/call center reporting and pre-paid envelopes/call center reporting both captured more events than e-mail reporting. 4 , 6 , 7 In an EPSS study of IIV4 in Germany and Spain in 2021/22, web-based/call center reporting captured fewer events than in the previous season using paper-based reporting. 8 Differences in reporting rates between seasons and data collection methods are due to various factors; however, enabling vaccinees to report directly into a web-based system appears to improve data quality and reporting impetus compared with traditional safety surveillance where AEFI are reported to and recorded by HCPs.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season

Machado,

Gandhi-Banga,

Gallo

et al. 2024

Human Vaccines & Immunotherapeutics

Self Cite

View full text Add to dashboard Cite

Enhanced Passive Safety Surveillance (EPSS) was conducted for quadrivalent inactivated split-virion influenza vaccines (IIV4) in Germany (high dose [HD]) and Finland (standard dose [SD]) for the northern hemisphere (NH) 2022/23 influenza season. The primary objective was to assess adverse events following immunization (AEFI) occurring ≤7 days post-vaccination. In each country, the EPSS was conducted at the beginning of the NH influenza season. Exposure information was documented using vaccination cards (VC), and AEFI were reported via an electronic data collection system or telephone. AEFI were assessed by seriousness and age group (Finland only). The vaccinee reporting rate (RR) was calculated as the number of vaccinees reporting ≥ 1 AEFI divided by the total vaccinees. In Germany, among 1041 vaccinees, there were 31 AEFI (ten vaccinees) during follow-up, including one serious AEFI. Of 16 AEFI (six vaccinees) with reported time of onset, 15 occurred ≤7 days post-vaccination (RR 0.58%, 95% confidence interval [CI] 0.21, 1.25), which was lower than the 2021/22 season (RR 1.88%, 95% CI: 1.10, 3.00). In Finland, among 1001 vaccinees, there were 142 AEFI (51 vaccinees) during follow-up, none of which were serious. Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s.

show abstract

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Choe¹,

Talanova²,

Shin³

et al. 2023

Infect Dis Ther

Self Cite

View full text Add to dashboard Cite

Introduction The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra ® ) was initially licensed in South Korea in 2017 for immunization against seasonal influenza in those aged ≥ 3 years, with the indicated age subsequently lowered to include those aged ≥ 6 months in 2018. Here, to comply with South Korean licensure requirements, we undertook a post-marketing surveillance study to assess the safety of QIV in children aged 6–35 months (i.e., extension of the previous age indication to include these young children) in routine clinical practice. Methods A multicenter, observational, active safety surveillance of children aged 6–35 months who received a single dose of QIV during a routine healthcare visit was undertaken in South Korea from 15 June 2018 to 14 June 2022. Solicited adverse events (AEs) and unsolicited non-serious AEs were recorded in diary cards, with serious adverse events (SAEs) notified to study investigators. Results This safety analysis included 676 participants. No AEs led to study termination, and no SAEs were reported. The most frequent solicited injection site reaction was pain in both the ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) in the ≥ 24-month age group. Overall, 208 (30.8%) participants experienced 339 unsolicited non-serious AEs, with nasopharyngitis the most common (14.1% [95/676]), and nearly all events (98.8% [335/339]) were considered unrelated to QIV. Grade 3 solicited reactions and unsolicited non-serious AEs were reported in five (0.7%) and three (0.4%) participants, respectively, all of whom recovered by day 7 after vaccination. Conclusion This active safety surveillance study confirms that QIV is well tolerated in children aged 6–35 months in routine clinical practice in South Korea. There were no safety concerns observed in these young children.

show abstract

Enhanced passive safety surveillance of high‐dose and standard‐dose quadrivalent inactivated split‐virion influenza vaccines in Germany and Finland during the influenza season 2021/22

Cited by 6 publications

References 18 publications

High‐Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults

High‐Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults

Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Contact Info

Product

Resources

About