By NewsDesk @bactiman63
Seqirus announced this week that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.
FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older. FLUCELVAX QUADRIVALENT will be available as a 0.5ml intramuscular (IM) vaccine per dose for the 2021/22 U.S. influenza season.
The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator. This represents the first absolute efficacy study of a cell-based influenza vaccine in this population.
“Young children are at a high risk of complications from influenza, which is why annual vaccination is critical,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “The absolute efficacy results for FLUCELVAX QUADRIVALENT that served as the basis for this approval indicate that the cell-based vaccine offers an important new option for children as young as two years of age.”
FLUCELVAX QUADRIVALENT utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing. There are several factors that can impact seasonal influenza vaccine effectiveness, which may include mismatch between circulating strains and the influenza strains contained within the seasonal influenza vaccine. Egg-based manufacturing requires a growth-inducing strain to ensure the influenza virus can grow successfully in eggs, which can cause the strain to mutate and result in an influenza virus that can be different from the intended strain. This may lead to a mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine. Cell-based influenza vaccines like FLUCELVAX QUADRIVALENT are designed to help avoid egg-adapted changes and may result in vaccine virus strains that are more closely matched to those selected by the World Health Organization. Cell-based influenza vaccine technology may offer additional advantages over the standard influenza manufacturing process, including being more scalable and offering faster production in the event of an influenza pandemic.
According to the Centers for Disease Control and Prevention (CDC), the best way to prevent influenza is by receiving an annual seasonal influenza vaccine. More than 52,000 hospitalizations occurred in children aged 18 years of age and younger during the 2019/20 U.S. influenza season, and there were over 434 influenza-related deaths in this age group. Children younger than five years of age are at high risk of developing serious flu-related complications. The CDC recommends everyone six months of age and older without contraindications receive an influenza vaccine annually.
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