Japan Lags Behind in COVID-19 Vaccination Goals, Looks to Hasten Approval of Second Vaccine

Japan initiated its COVID-19 vaccination program as early as mid-February with the Pfizer/BioNTech vaccine. However, it has only managed to administer just 46,500 doses in three weeks, which is about seven times lower than that of South Korea, which started a week later than Japan. Statistics point out that, at this rate, it will take approximately 126 years for Japan to vaccinate all its citizens.

The slow rate of Japan’s vaccine rollout is mostly attributed to lack of supply, shortage of specialty syringes, and the speed of emergency authorization. At present, the island nation has granted emergency authorization to only Pfizer/BioNTech’s mRNA vaccine BNT162b2. Vaccines manufactured by Moderna and Oxford/AstraZeneca vaccines are still under review.

Meanwhile, Japanese authorities had recently pointed out that BNT162b2 induced severe allergies (anaphylaxis) among the vaccinated people in Japan at a rate higher than the United States and Europe. As of March 10th, 25 of the 148,000 medical staff who received the vaccine developed severe allergic symptoms, while only five cases were reported out of the 1 million doses administered in the United States and 20 cases in the United Kingdom.

Emergency Approvals of other COVID-19 Vaccines

Former Health Minister Norihisa Tamura, who made a comeback as the Chief of the Ministry of Health, Labor and Welfare (MHLW), expressed that the emergency authorization review for a second COVID-19 vaccine will occur in May or June at the latest.

In early February, AstraZeneca filed a marketing approval application for its COVID-19 vaccine in Japan but still awaits a decision. At this juncture, Daiichi Sankyo announced on March 12th that it would start mass production of AZD1222, using undiluted solutions provided by AstraZeneca. Japan has purchased approximately 120 million doses of AZD1222 from AstraZeneca and entrusted local pharmaceutical factories such as Daiichi Sankyo, JCR Pharma, and others for manufacturing.

In early March, Takeda asked the Japanese regulators to grant emergency authorization to Moderna’s COVID-19 vaccine, mRNA-1273. Japan has purchased nearly 50 million doses of the vaccine, and Takeda will distribute them as part of a joint partnership.

Only two of Japan’s pharmaceutical companies have advanced their vaccine candidates to clinical trials. They are AnGes, Inc.’s DNA vaccines AG0302-COVID19 (Phase 3), and AG0301-COVID19 (Phase 2), and Shionogi’s recombinant subunit Vaccine S-268019 (Phase 2). In order to accelerate the R&D of local vaccines, the Japanese government plans to invest about 1.5 billion US dollars in the near future and cooperate with several Asian countries in cross-border clinical trials.

With the summer Olympics fast approaching, Japan is expected to ban overseas spectators from entering the venues and also determine the number of spectators who can enter in April.

Related Article: COVID-19: Japan’s Fujifilm Holdings Restarts Clinical Trials of Repurposed Drug Avigan, Seeking Approval by October

Author

Rajaneesh K. Gopinath