"Flucelvax Influenza Vaccine Shows Superior Efficacy Compared to Egg-Based Vaccines"

CSL Seqirus Korea Introduces Flucelvax and Fluad
Highlights Clinical and Economic Value of Next-Generation Influenza Vaccines

Global vaccine company CSL Seqirus Korea held a press conference on the 23rd to introduce its cell-based influenza vaccine "Flucelvax Quad Prefilled Syringe (Flucelvax)" and the adjuvanted influenza vaccine for the elderly, "Fluad Quad Prefilled Syringe (Fluad)."

Yoo Kisung, CEO of CSL Seqirus Korea, is giving a greeting at the influenza vaccine press conference on the 23rd. CSL Seqirus Korea

At the event, the significance of launching Flucelvax, the world’s first cell-based influenza vaccine, was highlighted. The latest cost-effectiveness data for Fluad from Korea and Taiwan was also shared, presenting a new direction for influenza vaccination.

Professor Noh Ji-yun, an infectious disease specialist at Korea University Guro Hospital, spoke on the topic of "cell-based influenza vaccines," introducing the distinctive features and clinical value of Flucelvax compared to conventional standard-dose egg-based vaccines.

Professor Noh explained, "Flucelvax, manufactured using a cell-based method, uses viruses isolated from cells to create the seed vaccine strain, and proliferates the vaccine strain in mammalian cells, which fundamentally blocks egg-adaptive mutations. This allows for more accurate implementation of the antigenicity of the vaccine strains selected by the World Health Organization (WHO), provides superior preventive efficacy compared to conventional egg-based vaccines, and also reduces immune imprinting-related distortion of immune responses."

Flucelvax has demonstrated superior influenza prevention efficacy compared to non-influenza vaccines and placebos across a wide age range, from children aged six months and older to adults, through various clinical studies. In particular, a real-world evidence (RWE) analysis in the United States involving a total of 106,779 individuals aged six months to 64 years found that during the influenza season, Flucelvax showed 19.8% higher preventive efficacy compared to standard egg-based vaccines.

Meanwhile, Flucelvax is the only cell-based influenza vaccine approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Australian Therapeutic Goods Administration (TGA). Based on the preventive benefits confirmed through various clinical studies and RWE, since 2024, Flucelvax has been provided to high-risk groups aged 5 to 64 as part of Australia’s National Immunization Program.

There was also a presentation by Professor Choi Minjun of Korea University Guro Hospital’s Department of Infectious Diseases on the topic of "Economic Evaluation of Adjuvanted Influenza Vaccines." Influenza is an infectious disease with high severity and mortality in people aged 65 and older. However, in this age group, the immune response after vaccination is relatively low, resulting in limited preventive efficacy. While the effectiveness of influenza vaccines in healthy adults ranges from 50% to 80%, in the elderly it drops to 16% to 64%, roughly half as effective. This is because the immune function of the elderly declines with age, making it difficult to expect sufficient protection from existing vaccines alone.

Professor Choi explained, "While antibody titers from conventional influenza vaccines typically decrease within an average of six months, studies have shown that Fluad maintains higher antibody levels even one year after vaccination, providing a practical advantage in reducing the gap until the next vaccination. Observational studies in people aged 65 and older have shown that Fluad demonstrated higher preventive efficacy compared to standard-dose influenza vaccines and also reduced the risk of severe diseases such as influenza-related hospitalizations."

He added, "Switching from standard influenza vaccines to adjuvanted vaccines is a rational choice not only from a medical perspective but also economically. These results suggest that adjuvanted vaccines like Fluad should be given sufficient policy consideration in future discussions on vaccine selection for the national immunization program targeting the elderly."

Yoo Kisung, CEO of CSL Seqirus Korea, stated, "We are pleased to offer more differentiated options in the field of influenza prevention, where unmet needs have existed. We hope that the clinical and economic evaluation data presented today will serve as a positive turning point for domestic influenza vaccine policy and vaccination environment."