Photo/Illutration Daiichi Sankyo Co.’s Daichirona, the first COVID-19 vaccine developed in Japan (Provided by Daiichi Sankyo Co.)

The health ministry has approved the manufacturing and sales of a coronavirus vaccine developed by Daiichi Sankyo, which is the first domestically produced vaccine for the virus that causes COVID-19.

Like the widely used ones developed by Pfizer Inc. and Moderna Inc., this is a messenger RNA (mRNA) vaccine.

Compared with its U.S. rivals, which must be stored at very low freezing temperatures, Daiichi Sankyo’s product has the advantage of allowing storage in a regular refrigerator.

There is no guarantee that foreign pharmaceutical companies can immediately produce a vaccine against any new variant of the virus that may emerge in Japan at any time. Thus, even though it has come far too late, Japan’s acquisition of the ability to procure a COVID-19 vaccine domestically still marks an important milestone.

When the first COVID-19 vaccines appeared, there was a global race to acquire sufficient supplies.

Japan’s security risk management is bolstered by having the capability to develop vaccines on its own. In addition to protecting the lives and health of the people, Japan can also use Japanese-made vaccines to make a significant international contribution by providing them to countries struggling to secure sufficient doses.

The government should make steady efforts to ensure that the new vaccine will help better prepare Japan for the emergence of unknown pathogens.

While some contend that weak policy support from the government and less financial resources available were why Japan lagged behind other leading industrial nations in developing COVID-19 vaccines, the principal factor was that Japan lacked the basic technological infrastructure for new drug discovery and development of new vaccines.

Based on a strategy formally adopted by the Cabinet two years ago, the new Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA) was established last year to develop new vaccines.

The body has started providing aid to more than 10 vaccine-related research projects, including some focused on unique technology.

Enhancing basic research capabilities and promoting improved collaboration between universities and companies are challenging goals that cannot be achieved overnight. First of all, it is crucial to build up necessary capabilities and resources in a wide range of fields over time.

An “emergency use authorization” system has also been established to authorize unapproved medical products such as promising new drugs and vaccines that have been developed in Japan ahead of other countries to be used in an emergency, even in the middle of clinical trials.

However, there still remains the difficult question of how to conduct large-scale clinical trials involving tens of thousands of volunteers in a short period of time for medical products made in Japan.

There are many challenges that need to be overcome, from securing human resources and hospitals involved in clinical trials to recruiting volunteers. These challenges cannot be left to companies to tackle on their own.

The health ministry has decided to support and subsidize final-stage clinical trials.

A new state agency for health crisis management, known as the Japanese version of the U.S. Centers for Disease Control and Prevention (CDC), set to be created under the initiative of Prime Minister Fumio Kishida’s government, will also be tasked with building an international network for clinical trials.

The health ministry, which will have oversight authority over the new body, needs to fulfill some important roles and responsibilities.

It is also vital to secure a certain level of production capacity. However, since it is difficult to predict when and to what extent infectious diseases will spread, drugmakers are reluctant to engage in costly projects to develop vaccines.

In addition to providing assistance in the form of hardware such as equipment, it is also necessary for the government to consider buying up and stockpiling vaccines. If no major outbreak of an infectious disease occurs, vaccines for the disease produced may end up remaining unused.

The government needs to launch a public awareness campaign to win public support for spending taxpayer money on such health crisis management projects.

--The Asahi Shimbun, Aug. 18