Japan’s Struggle for a Home-Grown COVID-19 Vaccine

In mid-February Japan delivered its first dose of COVID-19 vaccines – two months after the immunization campaign began in the U.K., Europe, and the United States.

While almost 100 million people around the world have received at least one dose of a vaccine, Japan is the last nation in the G-7 to begin vaccinations. Although Japan’s COVID-19 death toll per million people is relatively low at 13 deaths – compared to the U.K. and U.S., which have recorded over 600 deaths per million – it does not have time to lose. Vaccines are crucial for bringing the coronavirus outbreak under control and Japan’s relatively small and underdeveloped vaccine industry doesn’t stand a chance against the top four pharmaceutical companies, which collectively hold a 70 to 80 percent slice of the global market.

Japan is depending heavily on imported vaccines, having secured a total of 280 million doses from a combination of Pfizer-BioNTech, Moderna, and AstraZeneca vaccines at a massive cost of 671.4 billion yen ($6.4 billion). Japan will first inoculate 40,000 medical personnel, of which 20,000 will take part in a health observation survey. This will be followed by 3.7 million doctors, nurses, pharmacists, ambulance drivers, and other health personnel. People over 65 will be offered the vaccine in April, followed by the general population.

However, at this stage Japan has only approved the Pfizer-BioNTech vaccine, emphasizing the need for safety rather than speed. Pfizer’s international clinical trial was tested on 40,000 people, of which 4 percent were Asian. But since no Japanese subjects took part in the clinical trials there are concerns over ethnicity-specific side effects. Japan’s immunization campaign has been slowed down by requests from the Ministry of Health to hold local clinical trials in order to “confirm the effect of the vaccine on Japanese people.” In October a local clinical trial made up of over 200 Japanese participants took place, with final approval given in December.

The government’s effort to secure vaccines has led to foreign pharmaceutical companies being given liability exemptions with the Japanese government agreeing to take responsibility for the possibility of side effects.

Compared to the billions of dollars of research spent annually by major pharmaceutical companies based in the United States and Europe, Japan’s vaccine sector has been described as feeble. Currently, out of the 10 Japanese companies currently pursuing a vaccine only AnGes Inc. has proceeded to an advanced phase of clinical trials for its vaccine, based on plasmid DNA technology. Shionogi & Co. is also conducting early phase clinical trials for a recombinant protein vaccine and aims to manufacture vaccines for 30 million people by the end of the year.

The entry barriers to the global vaccine market are already high and there is the added cost of conducting large-scale international clinical trials, which are needed to expand business worldwide and recuperate investment. In addition, legal proceedings over unwanted side effects from the cervical cancer vaccine have led to what experts call a half-hearted approach to developing vaccines as a lawsuit could see the large amount of investment in vaccine development thrown down the drain.

The COVID-19 crisis has gripped Japan amidst a lack of leadership in the under-resourced vaccine sector. In 2016 a working group for the Ministry of Health outlined that Japan’s vaccine industry is facing a “crisis” and is being left behind by a so-called convoy system – a policy to protect the financially weakest companies at the expense of stronger companies.

Now the pandemic lays bare the risks of allowing Japan’s domestic capability to fall behind. Japan’s shipment of Pfizer vaccines from Belgium will require approval from the European Union (EU) and with Europe facing vaccine shortages there are concerns that supply to Japan will be disrupted until sufficient supplies are provided to the European people.

Prime Minister Suga Yoshihide said that as a form of crisis management the government plans to support the domestic development and manufacturing systems for home grown vaccines for unpredictable infectious diseases.

Commercializing Japan’s small-scale vaccine industry requires long-term investment and restructuring, and to deal with the COVID-19 crisis choosing an overseas vaccine is the least expensive option. There is deep-rooted pessimism that it is no longer possible for Japanese vaccine makers to compete with or match the speed of major manufacturers. However, others argue that Japan has no choice but to strengthen its vaccine development and rebuild the entire sector before the next pandemic strikes.