Japanese Regulatory Agency Confirms Safety and Efficacy of Pfizer's COVID-19 Vaccine

China News Service, February 8 — According to an interview with Japanese government sources conducted by Kyodo News on the 7th, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), which is responsible for national drug reviews, has compiled its review report and granted “special approval” with simplified review procedures, citing no particular issues regarding the safety and efficacy of Pfizer’s COVID-19 vaccine.

The report indicates that the Pharmaceuticals and Medical Devices Agency’s (PMDA) assessment means the initial hurdle for approval has been cleared. The report will be submitted to the Ministry of Health, Labour and Welfare’s expert panel convened on the 12th; if deemed appropriate, formal approval by the Minister of Health, Labour and Welfare is expected on the 15th.

According to reports, the first batch of vaccines is scheduled to arrive at Narita Airport in Japan from Brussels, Belgium, on the 14th. If preparations are complete, the government will prioritize vaccination for approximately 10,000 healthcare workers who have given their consent, with the aim of conducting safety surveys. Coordination efforts are currently underway to initiate vaccinations at medical institutions in Tokyo on the 17th. The government strives to provide vaccines to those willing to receive them as soon as possible, while ensuring overseas supply and improving local governments' vaccination systems remain key challenges.

After Pfizer Inc. submitted its approval application in December 2020, the Pharmaceuticals and Medical Devices Agency (PMDA) employed a special approval procedure that streamlined the domestic review process in Japan, conditional upon factors such as the emergency situation and prior approvals overseas. The PMDA conducted a detailed examination of clinical trial data and other relevant information, compiling its findings into a review report. In early February 2021, the PMDA consulted with external experts regarding the contents of the review report and concluded that approval was warranted, as no significant issues were identified.

Upon approval, to urgently carry out vaccination for the Japanese public, Japan's Ministry of Health, Labour and Welfare will advance the procedures for "temporary vaccination" under the Vaccination Act. As a result, vaccination costs will be borne by the state, and relief measures can be taken in case of health damage. Temporary vaccination is recommended by the state, and citizens have an obligation to make efforts to accept vaccination. Reports indicate that vaccination work can only begin after the relevant legal procedures are completed.

According to reports, the Japanese government has formulated a plan to begin vaccinating approximately 36 million elderly individuals aged 65 and older after April 1, following healthcare workers. However, the European Union has strengthened export controls on vaccines produced within its region, casting uncertainty over the schedule for vaccine supplies to Japan. To facilitate the smooth implementation of vaccination programs by local governments, it is also an urgent priority to establish the necessary operational frameworks.