Delayed COVID-19 vaccine roll-out in Japan.

To control the COVID-19 pandemic, high COVID-19 vaccination coverage is urgently needed in each country worldwide. According to Our World in Data COVID-19 vaccination tracking, by the end of April, 2021, the proportion of individuals who had received at least one dose of vaccination was 62% in Israel, 51% in the UK, 43% in the USA, and 28% in Germany. However, this proportion was quite low in other countries, such as Russia (8%) and South Korea (7%). Although Japan is preparing to host the Summer Olympic Games in Tokyo, only 4% of the population had been vaccinated as of May 21, 2021 (appendix).

Such a delay in vaccine roll-out in Japan can be attributed to the following three factors. First, the regulatory approval of COVID-19 vaccines in Japan has lagged behind other countries. Although Japan approved the first mRNA vaccine by Pfizer–BioNtech on Feb 14, 2021, which was the only available vaccine in the country as of April, 2021, there were several months of delay in approval compared with other high-income countries due to the regulatory requirement for a domestic clinical trial involving Japanese citizens and its own review process. Because the number of patients with COVID-19 has been smaller in Japan than in other countries, Japan has been unable to register into international clinical trials to prove vaccine efficacy. As such, as of April, 2021, other vaccine products were still under review or investigation in ongoing clinical trials, and changes in regulations for vaccine approvals are being considered after criticism.

Second, there has been a delay in vaccine importation. Although Japan made contracts with Pfizer–BioNtech to import 194 million doses of vaccine by the end of 2021, it has encountered several obstacles, such as the temporary halt in production lines and EU approval for exports. Overall, only 28 million doses had been imported by the end of April, 2021.

Third, the vaccine roll-out system has been insufficient for achieving mass vaccination. Less than 15% of imported doses have been used so far. In Japan, only nurses and medical doctors can legally vaccinate citizens, so many local governments responsible for the vaccine roll-out have struggled to hire enough qualified personnel. Usually in medical institutions, primary care doctors deliver vaccinations individually; however, their capacity is limited because they also need to offer other medical care as usual. Given that converting large public spaces into vaccination sites and recruiting enough staff are crucial for mass vaccination, the government has belatedly launched mass vaccination sites with the help of medical professionals belonging to the Self Defense Forces and other temporary staff.

According to the Prime Minister's Office of Japan, of the 3·85 million vaccinations delivered in Japan by the end of April, 2021, 94% (3·62 million) were for health-care workers; however, only around 22% (1·04 million) of these workers have received the second dose. It should be noted that slow roll-out could cause an emergence of new mutants. Although the government plans to complete the vaccination of 36 million older citizens (aged ≥65 years) by the end of July, 2021, it is necessary to devise innovative ways to solve these setbacks to achieve this ambitious goal as soon as possible.

AO reports personal fees from Medical Network Systems MNES. TT reports personal fees from Medical Network Systems MNES and Bionics. MKa reports personal fees from SBI Biotech and donations from Ain Holdings. All other authors declare no competing interests.