Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

home > Information > International Risk Information
International Risk Information|Information|Ministry of Food and Drug Safety

International Risk Information

MFDS to Approve World's First Cell Culture Flu Vaccine Thanks to Custom Approval Counselling Services
  • Registration Date 2016-04-15
  • Hit 1609

The Ministry of Food and Drug Safety (Minister: Kim, Seung-hee) announced that it has approved the world's first quadrivalent cell culture flu vaccine "SKYCellflu Quadrivalent."

The quadrivalent vaccine developed by SK Chemical inoculates against two types of A influenza viruses and two types of B influenza viruses.

At the moment, the cell culture influenza vaccines approved in Korea, U.S., Europe, etc. are trivalent vaccines (two type A and one type B products) and have used fertilized eggs.

The new vaccine has been approved for use by the population aged 19 and over. It is the second vaccine following "SkyCellFlu Pre-filled Syringe (trivalent)" that was approved last December, and is the fifth influenza vaccine that is developed in Korea.

Because no eggs are involved in cell culture vaccines, they are not affected by the supply of fertilized eggs, making them a more popular choice among the vaccine manufacturers.

The tailored counseling services offered in such areas as review/evaluation, clinical studies and GMP under "Global Vaccine Productization Support Team" were behind the successful development and approval of the vaccine, emphasized the MFDS.

In addition, the MFDS is planning to provide the industry with further vaccine development and commercialization aids that will boost the self sufficiency rate of vaccines of Korea, cope with a future influenza pandemic and advance into a global market.

Global Vaccine Commercialization Support Team launched in 2010 by the MFDS is designed to provide domestic vaccine manufacturers with intense technical counselling support services.

Press Release, Dec., 24, 2015

Attached File

Division

Written by Sung Hwa, Hong/ Do Keun, Kim