World's 1st cell-cultured flu vaccine using cell-derived strain to be launched in Korea

CSL Seqirus Korea announced on Thursday that it will launch the world's first cell-cultured influenza vaccine, FlucelvoxQuad, this month.

FlucelvoxQuad received approval from the Ministry of Food and Drug Safety in August 2024 and can prevent infections caused by influenza A and B viruses in children aged six months and older and adults. Starting this 2025/26 season, FlucelvoxQuad vaccinations will be available at major hospitals and clinics nationwide.

Influenza is an infectious disease that places a significant burden on healthcare systems and the broader socioeconomic landscape across all age groups, with vaccination being the most effective preventive measure. However, existing egg-based influenza vaccines have limitations, as egg adaptation mutations can occur during the production process.

This refers to the phenomenon where viruses cultured in eggs mutate into forms different from the actual circulating influenza viruses, leading to reduced antigenic match and potentially diminished vaccine efficacy.

FlucelvoxQuad is recognized as the only cell-cultured vaccine that prevents egg adaptation by utilizing a cell-derived candidate vaccine virus (Cell-CVV) from the outset. It utilizes strains isolated from cells as seed stocks and propagates them in mammalian cells, preventing egg adaptation mutations that occur in the fertilized egg culture method.

This enables more accurate antigenic matching with the actual circulating viruses selected by the World Health Organization (WHO), allowing for enhanced vaccine efficacy. Furthermore, since no fertilized eggs are used in the manufacturing process, it can be safely administered to patients with severe egg allergies. It is also unaffected by fluctuations in egg supply, enabling a stable supply even during pandemics.

In clinical studies, FlucelvoxQuad demonstrated excellent influenza prevention efficacy by reducing the risk of symptomatic influenza disease in children aged six months and older, adolescents, and adults. Specifically, in the United States, relative vaccine effectiveness was evaluated annually over three seasons in approximately 30,000 participants ranging from children aged four years and older to adults under 65 years.

Results confirmed that FlucelvoxQuad reduces influenza incidence by at least 10 percent and up to 14.8 percent compared to egg-based influenza vaccines. Furthermore, various real-world evidence (RWE) studies have also shown that FlucelvoxQuad significantly reduces influenza-related medical visits, healthcare utilization, and hospitalization rates compared to egg-based vaccines.

In terms of safety profile, FlucelvoxQuad demonstrated equivalent safety to egg-based vaccines and was confirmed safe across a wide age range, from infants aged six months and older to adults. Notably, FlucelvoxQuad is the only cell-cultured vaccine with confirmed safety in pregnant women. A study involving 665 pregnant women showed no specific abnormalities in pregnancy or newborn health outcomes, with preterm birth rates and low birth weight rates similar to those in the general population.

“As FlucelvoxQuad overcomes the limitations of egg-based vaccines and demonstrates superior preventive efficacy, we expect it to play a meaningful role in safeguarding public health and safety,” CSL Seqirus Korea CEO Yoo Kee-seung said.