Japan’s public health response to the global pandemic relied heavily on a vaccination effort. The national strategy focused on securing a stable supply of effective vaccines and administering them efficiently across the population. This undertaking represented one of the largest public health campaigns in the nation’s history, requiring rapid regulatory action and the establishment of complex distribution networks.
Japan’s Regulatory Pathway for Vaccine Approval
The swift authorization of COVID-19 vaccines in Japan was managed through an expedited system established under the nation’s Pharmaceutical and Medical Devices Act (PMD Act). This special mechanism, referred to as “Special Approval for Emergency” (SAFE), allowed the Ministry of Health, Labour and Welfare (MHLW) to accelerate the review process far beyond the typical timeline for new pharmaceutical products. The SAFE system permitted the MHLW to grant approval for foreign-developed medical products in urgent situations, provided certain conditions were met.
A product qualified for this emergency pathway if it addressed a disease posing a serious public health threat and if no suitable alternative treatment was available within the country. Furthermore, the vaccine had to have already received authorization for sale in a foreign country, such as the United States or a major European nation. For instance, the MHLW was able to review the application for the Pfizer/BioNTech vaccine in just 58 days, a pace considered unprecedented for the Japanese regulatory environment.
The MHLW’s evaluation process prioritized comprehensive safety and efficacy data derived from large-scale international Phase 2/3 clinical trials. While the bulk of the data came from overseas studies, the MHLW also required the submission of a smaller set of data specific to the Japanese population, focusing on safety and immunogenicity. This dual approach ensured that the regulatory decision was grounded in broad international evidence while also considering any unique responses within the domestic population.
Authorized Vaccines and Their Specific Uses
Japan has authorized a diverse portfolio of COVID-19 vaccines, utilizing various technological platforms. The initial rollout was dominated by messenger RNA (mRNA) vaccines, specifically Comirnaty from Pfizer/BioNTech and Spikevax from Moderna, which provided high efficacy against the original viral strains. These mRNA vaccines were authorized for use as both primary series and booster shots, with eligibility continually expanded to include younger age groups, eventually reaching children as young as six months.
The vaccine supply was further diversified with the authorization of viral vector and protein subunit technologies. The viral vector vaccine from AstraZeneca (Vaxzevria) and the protein subunit vaccine from Novavax were also approved for use, adding flexibility to the program. Notably, the Novavax vaccine was manufactured domestically within Japan by Takeda Pharmaceutical, securing a localized supply chain for the protein-based platform.
The recombinant vector vaccine from Janssen (Johnson & Johnson) was also authorized, distinguished by its single-shot primary series regimen for individuals aged 18 and older. However, unlike the other major vaccines, the Japanese government did not procure the Janssen vaccine for the national free public program. A significant milestone was the approval of the first Japanese-made mRNA vaccine, Daichirona from Daiichi Sankyo, which was authorized for use as a booster shot. Subsequent approvals for Daichirona focused on updated monovalent formulations targeting circulating Omicron sublineages, such as XBB.1.5 and JN.1, positioning it as a key component of seasonal booster campaigns.
Current Status of the National Vaccination Program
The national vaccination program has resulted in high population coverage rates across the country. As of early 2024, approximately 80% of the population had received their second dose, with booster uptake exceeding two-thirds of the population. The logistical framework for administering these doses relied on a combination of local medical institutions, such as clinics and hospitals, and large-scale mass vaccination centers established in major urban areas.
A unique element of the distribution strategy was the “workplace vaccination program,” which allowed large companies and organizations to administer vaccines directly to their employees, accelerating the rollout. Throughout the temporary emergency period, the costs of the vaccine doses were fully covered by public funds, making the vaccination entirely free for all eligible residents, including Japanese nationals and foreign residents.
The program has undergone a policy shift, moving away from the temporary, emergency-driven mass campaign toward a more routine, seasonal approach. The free public vaccination program, categorized under the temporary inoculation law, was scheduled to conclude in March 2024. Under the new framework, COVID-19 vaccination is transitioning to a routine immunization for certain groups, similar to the annual influenza shot.
The revised policy focuses on annual autumn-winter vaccination for high-risk populations: those aged 65 and older and individuals between 60 and 64 with severe underlying health conditions. While the government will continue to subsidize the cost of these routine shots, recipients may be required to bear a portion of the expense, marking a change from the completely free model. This transition normalizes the COVID-19 vaccine within the existing public health infrastructure.