Efforts to Localize Vaccine Production

Korea's vaccine self-sufficiency rate increased to 53.5% this year, setting a new record.

The South Korean government is unlikely to attain its goal of boosting the nation's vaccine self-sufficiency rate to 70 percent by 2020 due to delays in clinical trials and research and development on next-generation vaccines.

According to the industry on October 3, Korea has succeeded in localizing 15 of the targeted 28 vaccines. Last year, SK Bioscience commercialized shingles vaccine for the second time in the world, and GC Green Cross succeeded in developing tetanus and diphtheria (Td) vaccine for adults. The vaccine self-sufficiency rate has increased to 53.5% this year, setting a new record.

However, the tuberculosis vaccine and the polio vaccine, which are considered to be two most important vaccines, are in a supply crisis every year because they are all imported. Last year, when the polio vaccine was in a worldwide supply shortage, the government postponed the booster injection period for four to six year-olds two times. This problem was also due to foreign pharmaceutical companies changing the vaccine manufacturing process for single vaccine to that for mixed vaccine.

So far, humans have succeeded in developing vaccines for 28 kinds of diseases. The Korean government divides these into essential vaccinations (19), other vaccinations (5), and counter-terrorism and pandemic vaccinations (4), according to the World Health Organization (WHO) standards. However, in case of the essential vaccinations, which are for diseases that can spread any time and have a high possibility of endangering lives, only nine of the 19 vaccines have succeeded in localization. The remaining 10 vaccines are all imported from foreign pharmaceutical companies.

The industry sees that it is impossible to reach the vaccine self-sufficiency rate of 70% by 2020, as the government has planned. To achieve this goal, five additional vaccines must be developed over the next two years, and yet many of which are still in the early stages of clinical trials. This is why industry officials pointed out that the government has overlooked the fact that vaccine is a biopharmaceutical that uses living strains as a raw material that requires a lot of time and money for development.

With the vaccine crisis recurring every year, the government laid out the “vaccine supply and demand stabilization plan for essential vaccination” for the first time last month. The government will preemptively estimate the amount of vaccine needed and purchase foreign vaccines through long-term contracts over the next three to five years. This way, the government can purchase three to six months-worth in advance and reserve the vaccine that is expected to be in short supply. However, it is pointed out that it is still a temporary policy because the budget is only 1 billion won (US$900 million).

An official in the domestic pharmaceutical industry said, "Although the domestic vaccine technology has reached the highest level in the world, the global vaccine market is shifting to focus on “premium vaccine” against non-life-threatening diseases, such as shingles vaccine. In order for domestic companies to compete with global pharmaceutical companies like Pfizer, Sanofi and GSK in the domestic vaccine market, it is necessary for the government to act on proactive policies, such as ensuring minimum sales volume rather than simply supporting clinical trial costs."

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