· The world first cell culture-based influenza vaccine, ‘SKYCellflu®’ is approved for the first time in South America
· SKYCellflu which also acquired WHO PQ for
the first time as a cell culture-based influenza vaccine, is now approved in 11
SK bioscience, a global innovative vaccine and
biotech company committed to promoting human health from prevention to cure
across the globe, announced that the company’s world first cell culture-based quadrivalent
influenza vaccine, ‘SKYCellflu’ has been approved by ‘Instituto de Salud Publica de Chile (Institute
of Public Health, ISP)’ for the first time in the South American region.
Previously, SK bioscience obtained approval of
SKYCellflu in Southeast Asia and the Middle
East regions such as Malaysia, Thailand, Philippines, Myanmar, Singapore,
Pakistan, Mongolia, Iran and Brunei. Starting with Chile, SK bioscience plans
to expand the global influenza vaccine market in Central and South America.
SKYCellflu is a world first cell culture-based influenza vaccine developed by
SK bioscience. Compared to currently authorized fertilized chicken egg-based influenza
vaccines, the manufacturing period is about half short, so it has the advantage
to quickly respond to pandemics or the emergence of any variants.
Furthermore, the cells are cultured through the
newest aseptic incubators without any antibiotics or preservatives, so people
with egg anaphylaxis or egg allergy can be safely administered.
SKYCellflu showed clinically acceptable immunogenicity and safety in its Phase III
clinical trials with 1,503 adults over 19-year-olds at 10 institutions in South
Korea. It also proved clinically acceptable immunogenicity and safety in Phase III
clinical trials conducted with 453 children and adolescents between 6 months through
19-year-olds at 8 institutions.
The vaccine has also obtained the WHO PQ
(Pre-Qualification), which certifies safety and efficacy by evaluating the
manufacturing process, quality, and clinical trial results of vaccines.
During the COVID-19 pandemic, SK bioscience temporarily
suspended manufacturing of SKYCellflu to focus COVID-19 vaccines. The manufacturing of SKYCellflu will be resumed in this year to target influenza vaccination season.
Jaeyong Ahn, CEO of SK bioscience said, “SKYCellflu which will be resumed to be manufactured in this year, will
contribute public health beyond Korea to the world. We will do our best that
our self-developed vaccines will help promoting global health security.”