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R&DR&D Hightlights

Green Cross’ Tetanus-Diphtheria (Td) Vaccine Wins Approval

17 Mar, 2017

Immunization against tetanus and diphtheria is required by law under the National Immunization Program (NIP) in S.Korea. The Td vaccine is designed to immunize people against both tetanus and diphtheria; however, there are only three pharmaceutical companies in S.Korea that distribute a government-approved Td vaccine today. Because all of these vaccines are imported, the demands for local development and production of the Td vaccine have increased.

In 2006, Green Cross embarked on the ambitious project to develop a tetanus-diphtheria-pertussis (Tdap or Dtap) vaccine to meet this demand.

As a latecomer to Td vaccine development, Green Cross sought to distinguish its product from others by increasing the purity of the toxoid antigens used in its vaccine. Unlike other manufacturers, Green Cross opted for developing a suspended cell culture using a culture machine instead of the more typical cell culture procedure and also introduced chromatography into the purification process to filter out particles using molecular weight differences, which has enabled the production of higher-purity toxoid antigens.

The Phase 3 clinical trial of Green Cross’ Td vaccine involved comparing it against other Td vaccines available on the Korean market. Green Cross’ product yielded sero-conversion rates (SCRs) of 100 percent against both tetanus and diphtheria, placing it at the same level as the imported vaccines, and it even yielded a higher geometric mean rate (GMR). The results of the trial were published in an international medical journal and enhance the prospects for the vaccine’s commercial success in a competitive global market.

The vaccine market for Tdap vaccines is sizable and growing, generating KRW 3 trillion in global revenue annually thanks to the 220 million doses administered worldwide every year. Green Cross’ new Td vaccine is expected to reduce the demand for imported Td vaccines in S.Korea by about 450,000 doses a year and will pave the way for the company’s future vaccine R&D.