South Korean biopharma developer Green Cross said Wednesday that its self-developed tetanus-diphtheria vaccine for adults has been approved by the Korean Ministry of Food and Drug Safety.

It is the first time that a Korean drugmaker has successfully developed and scored regulatory approval to commercialize a Td vaccine here.


Right now, Koreans are mandated to receive a Td vaccine between the ages of 10 and 12, and receive new vaccine shots every 10 years.

Until now, Td vaccines were entirely imported from overseas drug vendors due to the lack of a domestic counterpart. Now, a large portion of these imported Td vaccines are likely to be replaced by those of Green Cross, the firm said.

The Drug Ministry said it expects imported Td vaccines able to treat some 450,000 patients will be replaced with domestic ones.

Green Cross expects its new Td vaccine to become available in Korea from next year.

Looking ahead, the Korean drugmaker plans to export its Td vaccine in the future. It is currently conducting the phase 1/2a clinical trials of a Tdap vaccine -- a multifunctional vaccine for not only tetanus and diphtheria, but also pertussis. 

By Sohn Ji-young (jys@heraldcorp.com)