Korea's first cell-culture influenza vaccine 'SKYCellflu' released

 

World's second commercially-available cell-culture influenza vaccine developed by SK Chemicals

Fast mass production, rapid response to mutative flu strains

Refined high-purity vaccine without the use of eggs, antibiotics, or preservatives

Korea's first cell-culture influenza vaccine 'SKYCellflu' released

 

 

The influenza vaccine market is heating up ahead of this year's vaccination season. The demand for vaccine inoculation has increased as various influenza virus strains have become prevalent following the avian influenza, swine influenza, and this year's "Hong Kong influenza" (H3N2 subtype). According to the Ministry of Food and Drug Safety, approximately 20 million doses of influenza vaccines are estimated to be supplied this year, an increase over last year. In a market more competitive than ever following the heightened demand, a new influenza vaccine exhibiting rapid response to mutated influenza strains has been developed entirely withKorean technology.

SK Chemicals has succeeded in commercializing the world's first cell-culture influenza vaccine for children and adolescents between the ages of 6 months to 18 years as well as the world's second for adults. The company obtained national marketing authorization last December for SKYCellflu, and the vaccine will be supplied beginning this year. This season, shipment approval was earlier than in previous years, and influenza vaccine inoculation is likely to begin by the 20th of this month.

 

Rapid response to viruses

Existing preventive vaccines have been shown to be ineffective against genetically-mutated influenza virus strains like the recent outbreak in Hong Kong. Cell-culture vaccine manufacturing technology has the advantage of being able to respond more quickly to such situations. This is because the technology shortens the six-month production time of traditional methods to less than half.

Furthermore, vaccines of identical effectiveness can be mass produced in less time. SK Chemicals' L-House, the cell-culture vaccine plant located in the city of Andong, has a maximum annual production capacity of 140 million doses and is capable of manufacturing and supplying the entire population of South Korea with vaccines should an influenza pandemic occur. In addition, the facility is equipped with a state-of-the-art next-generation aseptic production system to immediately mass-produce newly-developed vaccines for new infectious diseases.

 

Refined high-purity cell-culture vaccine without the use of eggs, antibiotics, or preservatives... "Establish vaccine independence…"

Until now, the only production method used for domestically-available influenza vaccines was egg-based.

SK Chemicals' SKYCellflu, Korea's first cell-culture influenza vaccine, is produced without the use of fertilized eggs and is instead produced using a state-of-the-art sterile incubator, eliminating the need for antibiotics or preservatives. Thus, the vaccine is safe for those who are allergic to eggs or sensitive to antibiotics.

SK Chemicals' goal is to use the launch of SKYCellflu as a springboard to bring about change in the current domestic market that relies on imported vaccines for more than half the supply and eventually penetrate developed overseas markets.

To improve vaccine self-sufficiency, SK Chemicals has invested approximately ₩400B ($337M USD) toward its vaccine business infrastructure and R&D, and the company has been busy developing a world-class vaccine. A full-scale R&D investment toward its vaccine business began in 2008 as the company's next-generation growth engine, and in 2012, SK Chemicals completed construction of L-House, the country's largest domestic vaccine plant, in Andong, North Gyeongsang Province.

SK Chemicals is currently preparing market introduction of its cell-culture quadrivalent influenza vaccine with plans to compete on an international level.

SK Chemicals' President Man-hun Park stated, "[SK Chemicals] will change the paradigm of the current vaccine market starting with the launch of SKYCellflu." He continued, "We will work toward realizing our vision of promoting human health and establish vaccine independence on a national level."

The L-House vaccine plant in Andong has begun shipping the initial batch of SKYCellflu, and the vaccine is expected to reach medical institutions throughout the country beginning on the 20th of this month.

 

[Glossary]

1. Swine influenza

The swine influenza outbreak in 2009 affected people on a global scale and caused 252 deaths in South Korea alone. Rapid response to this type of mutative influenza virus is difficult with existing egg-based vaccines that require up to six months from production to inoculation. According to forecasts by the World Health Organization (WHO), such virus strains will emerge more quickly and frequently in the future, so demand for technology development is greater than ever.

2. SKYCellflu

SKYCellflu® is a cell-culture influenza vaccine developed by SK Chemicals and is referred to as a "subunit vaccine" (basic unit of biological particles) and is considerably more refined when compared to a split vaccine. Vaccine components that could lead to side effects without contributing to the immune system were removed, and those that were effective in the immune response were refined to be used as antigens. Of the many virus components, the subunit vaccine isolated HA and NA, the surface antigens critical for antibody formation. Because of the vaccine's high purity, its local and systemic side effects are known to be low compared to a split vaccine. According to research results, surface antigen vaccines exhibited decreases of 14.6% in local adverse reactions and 9.2% in systemic adverse reactions when compared to split vaccines. (Ministry of Food and Drug Safety, "Evaluation of Efficacy of Influenza Vaccines" 2008)

 

3. Quadrivalent influenza vaccine

This type of vaccine is able to prevent against infection from four viruses in a single inoculation. It protects against two Type-A influenza strains and two Type-B influenza strains.

 

 

SK Chemicals Public Relations

Seong-woo Kim, Team Manager (010-5248-5308)

Chang-hyeon Jin, Assistant Manager (010-2041-8010)

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