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November 12, 2018

Producing Safe Vaccines in Vietnam: Japan's Successful 20-Year Effort to Transfer Technology

In Vietnam, it has become possible to produce safe, high-quality vaccines, which is proving useful in preventing infectious diseases.

With the cooperation of Kitasato Daiichi Sankyo Vaccine Co., Ltd., one of Japan's leading vaccine manufacturers, JICA has been working on projects to strengthen Vietnam's capacity to produce vaccines for the past 20 years.

Cultivating an attenuated virus to produce a live vaccine requires advanced skills. This article describes the long years of persistent effort by Japanese technical experts who led the projects to success and The Centre for Research and Production of Vaccines and Biologicals (POLYVAC), the Vietnamese vaccine manufacturing agency.

photoVietnamese technicians who manufacture vaccines

It's essential to ensure that techniques take root locally

photoThe Centre for Research and Production of Vaccines and Biologicals (POLYVAC) in Hanoi, the capital of Vietnam

The efforts of JICA and Kitasato Daiichi Sankyo Vaccine began in earnest with the construction of a vaccine manufacturing facility in 2002. Attempts to transfer measles vaccine manufacturing techniques began in 2006, and it first became possible to produce the vaccine in Vietnam in 2010. That vaccine is currently being used for routine immunization of 9-month-old infants.

"The transfer of the measles vaccine production technique to a foreign country was our first such initiative. Vietnam has different raw materials and facilities, so at first, I was at a loss," said Tomio Lee, assistant manager of the project, who was involved in the effort for about 20 years.

photoJapanese experts, right, instruct technicians from POLYVAC.

Through a long process of trial and error, the Japanese experts optimized Japanese techniques for the Vietnamese environment and painstakingly taught their counterparts the manufacturing method. To accurately convey experts' thoughts, Vietnamese interpreters created their own dictionary of specialized terms related to vaccine manufacturing.

Shuzo Ishikawa of Sakura Global Solutions coordinated the work so that the project would proceed smoothly. He provided education in carefully following "WHO Good Manufacturing Practices for Pharmaceutical Products" established by the World Health Organization so the vaccine would be manufactured appropriately. Mr. Ishikawa also guided the creation of a detailed operation sheet to allow the Vietnamese technicians to produce the vaccine properly after the project ended. He came up with many innovations to bring up the local technicians, including holding a daily morning assembly and establishing regular weekly meetings to confirm that work was proceeding smoothly and discuss how to address any issues.

photoProject Manager Setsuo Arai, right, and Assistant Project Manager Tomio Lee, third from right, both of Kitasato Daiichi Sankyo Vaccine, give technical instruction at POLYVAC.

"We experts can manufacture the vaccine in Vietnam using Japanese techniques. But the most important thing is how to ensure that the techniques take root in Vietnam," said Project Manager Setsuo Arai. These words were proven correct when there was a measles epidemic in Vietnam in 2013. With large amounts of vaccine urgently needed, POLYVAC produced in just six months the quantity of measles vaccine Kitasato Daiichi Sankyo Vaccine typically produces in 10 years in Japan and quickly prevented the epidemic's spread. The Japanese experts all say with confidence that this proved what they had been doing was correct.

Using trust as a base to transfer measles-rubella combined vaccine technology

Faith in and expectations for Japanese technology increased, and in 2013 an effort began to transfer the technology to manufacture measles-rubella combined vaccine. The number of rubella cases in Vietnam was growing faster than in neighboring countries. Rubella is not just a problem for children. If a pregnant woman catches rubella, it increases her risk of giving birth to a child with a congenital disorder. So, preventive measures were needed.

photoClinical study of the measles-rubella combined vaccine

At the time there was also an incident in Vietnam in which a child died after receiving an imported vaccine. Yasuhiro Tsuchida, who was in charge of organizational management for the project, said, "Using vaccines to protect the children who are the future of your country is nothing less than national defense. That's why the Vietnamese had an ardent wish to create a high-quality vaccine themselves."

photoThe measles-rubella combined vaccine produced by POLYVAC

Young technicians from POLYVAC who were involved in the transfer of measles vaccine manufacturing technology became managers in the manufacturing department when the measles-rubella combined vaccine was being produced, and Japanese experts watched over them as they did repeated experiments to work toward efficient production. When problems were found, they thoroughly followed their respective problem-solving methods, and a relationship of trust developed over many years drove the project forward. Then, in March 2017, the first domestically produced measles-rubella combined vaccine was approved for sale by the government of Vietnam. It is already being used for routine immunization.

That achievement has won a lot of respect. This year the project received the JICA President's Award and the Public Health Award (sponsored by Dai-Ichi Life Insurance Company and backed by The Ministry of Health, Labour and Welfare).

Considering exports to neighboring countries to prevent infectious diseases

Vietnam is now taking a step forward to export the vaccines it learned to produce through the project to neighboring countries. To do so, it will be essential for it to continue to maintain quality that complies with WHO standards. After the project ends in May 2018, Japanese experts will continue providing technical support so Vietnam can stably supply vaccines that meet the criteria on an ongoing basis.

"I want Vietnam to become one of the top vaccine suppliers in Asia. I would be happy if the seeds we sowed could be useful to many countries," said Mr. Arai.

The bonds forged between Japanese experts and Vietnamese technicians will persist.

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