Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to &lt;18-year-old children and adolescents at risk of influenza-related complications

Díez-Domingo, Javier; Martino, Maurizio de; Lopez, Jose Garcia Sicilia; Zuccotti, Gian Vincenzo; Icardi, Giancarlo; Villani, Alberto; Moreno-Pérez, David; Hernández, M.; Aldeán, Javier Álvarez; Mateen, Abdul; Enweonye, Igwebuike; Rooij, Richard de; Chandra, Richa

doi:10.1016/j.ijid.2016.06.018

Cited by 7 publications

(3 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Safety data (pertaining to both QIVc and the TIVc comparators) from these trials were generally consistent with those from numerous clinical studies of TIVc in adults and children [13, 18–22, 29–33], with the additional strain not altering the safety profile of the QIVc vaccine; no new safety signals were identified [13]. The clinical development program for TIVc found it to have a safety profile comparable to that of an egg-based trivalent influenza virus vaccine [13, 18–22, 31, 32, 34]. Post-marketing safety data are available for TIVc, representing millions of adults and children vaccinated in Europe and the USA in the 2016/2017 influenza season, and have confirmed its established safety profile [13]; similarly, an earlier surveillance study in the USA (2013–2015) found no concerning patterns in the adverse events reported in TIVc recipients [35].…”

Section: Reactogenicity and Safetysupporting

confidence: 70%

Cell-Based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza

Lamb

2019

Drugs

View full text Add to dashboard Cite

Manufacturing influenza virus vaccines using a mammalian cell line rather than embryonated chicken eggs may carry certain advantages. A quadrivalent inactivated influenza virus vaccine produced using the Madin Darby canine kidney cell line has been approved in the EU (Flucelvax® Tetra) and USA (Flucelvax Quadrivalent®; QIVc hereafter) for the prevention of influenza in adults and children. The clinical development of QIVc has built upon that of a cell-based trivalent influenza virus vaccine (TIVc) manufactured using the same processes; the additional influenza B strain contained in QIVc reduces the risk of the strain in the vaccine not matching that in circulation. Pivotal phase III clinical trials in adult and paediatric participants have demonstrated the immunogenicity of QIVc to be noninferior to that of TIVc formulations against shared strains and superior against the influenza B strain absent from each TIVc formulation. Protective efficacy data for TIVc is considered foundational for QIVc and, in a phase III clinical trial, TIVc was effective in protecting adults against antigenically matched influenza strains. Large real-world studies from the 2017/2018 US influenza season further support the prophylactic effectiveness of QIVc, with possible benefits over egg-based vaccines. QIVc was generally well tolerated in clinical trials. In adult and paediatric QIVc recipients, the most common solicited adverse reactions were injection site pain and headache. Reactogenicity was comparable to that of TIVc; no safety signals unique to QIVc emerged. Through circumventing concerns around egg adaptation, QIVc has the potential to be more effective than currently available egg-based quadrivalent vaccines.Electronic supplementary materialThe online version of this article (10.1007/s40265-019-01176-z) contains supplementary material, which is available to authorized users.

show abstract

Section: Reactogenicity and Safetysupporting

confidence: 70%

Cell-Based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza

Lamb

2019

Drugs

View full text Add to dashboard Cite

show abstract

“…Moreover, we detected a wider range of AEs as signals with egg-based vaccines compared with cell-based vaccines, suggesting that safety profiles among these two subtypes may differ, which is inconsistent with the results of previous studies. Two RCTs demonstrated that cell-based and egg-based TIVs had comparable safety profiles in children and adolescents < 18 years of age 26,27 . We believe that this situation may be due to the following reasons.…”

Section: Signal Detectionmentioning

confidence: 99%

Post-marketing surveillance study on influenza vaccine in South Korea using a nationwide spontaneous reporting database with multiple data mining methods

Lee

Hong

Kim

et al. 2022

Sci Rep

View full text Add to dashboard Cite

Safety profiles of the influenza vaccine and its subtypes are still limited. We aimed to address this knowledge gap using multiple data mining methods and calculated performance measurements to evaluate the precision of different detection methods. We conducted a post-marketing surveillance study between 2005 and 2019 using the Korea Adverse Event Reporting System database. Three data mining methods were applied: (a) proportional reporting ratio, (b) information component, and (c) tree-based scan statistics. We evaluated the performance of each method in comparison with the known adverse events (AEs) described in the labeling information. Compared to other vaccines, we identified 36 safety signals for the influenza vaccine, and 7 safety signals were unlabeled. In subtype-stratified analyses, application site disorders were reported more frequently with quadrivalent and cell-based vaccines, while a wide range of AEs were noted for trivalent and egg-based vaccines. Tree-based scan statistics showed well-balanced performance. Among the detected signals of influenza vaccines, narcolepsy requires special attention. A wider range of AEs were detected as signals for trivalent and egg-based vaccines. Although tree-based scan statistics showed balanced performance, complementary use of other techniques would be beneficial when large noise due to false positives is expected.

show abstract

“…Cell-grown IIVs offer an alternative to egg-based vaccines. Cell-grown QIVs or TIVs have good immunogenicity profiles and may have a modest improvement over egg-based vaccines in children and adolescents (164,165) while having similar safety profiles to those of egg-based IIVs in children (166,167). One study found that the recombinant HA-based vaccine outperformed the virion-based IIV in both HA-specific cellular and serological responses in adults (168).…”

Section: Future Perspectivesmentioning

confidence: 99%

Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review

2021

View full text Add to dashboard Cite

Annual influenza vaccination is often recommended for pregnant women and young children to reduce the risk of severe influenza. However, most studies investigating the safety, immunogenicity, and efficacy or effectiveness of influenza vaccines are conducted in healthy adults. In this evidence-based clinical review, we provide an update on the safety profile, immunogenicity, and efficacy/effectiveness of inactivated influenza vaccines (IIVs) in healthy pregnant women and children <5 years old. Six electronic databases were searched until May 27, 2021. We identified 3,731 articles, of which 93 met the eligibility criteria and were included. The IIVs were generally well tolerated in pregnant women and young children, with low frequencies of adverse events following IIV administration; however, continuous vaccine safety monitoring systems are necessary to detect rare adverse events. IIVs generated good antibody responses, and the seroprotection rates after IIVs were moderate to high in pregnant women (range = 65%–96%) and young children (range = 50%–100%), varying between the different influenza types/subtypes and seasons. Studies show vaccine efficacy/effectiveness values of 50%–70% in pregnant women and 20%–90% in young children against lab-confirmed influenza, although the efficacy/effectiveness depended on the study design, host factors, vaccine type, manufacturing practices, and the antigenic match/mismatch between the influenza vaccine strains and the circulating strains. Current evidence suggests that the benefits of IIVs far outweigh the potential risks and that IIVs should be recommended for pregnant women and young children.

show abstract

Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications

Abstract: TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).

Cited by 7 publications

References 16 publications

Cell-Based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza

Cell-Based Quadrivalent Inactivated Influenza Virus Vaccine (Flucelvax® Tetra/Flucelvax Quadrivalent®): A Review in the Prevention of Influenza

Post-marketing surveillance study on influenza vaccine in South Korea using a nationwide spontaneous reporting database with multiple data mining methods

Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review

Contact Info

Product

Resources

About