Japan still not ready to approve AstraZeneca vaccine

TOKYO -- AstraZeneca's coronavirus vaccine has yet to be approved for practical use in Japan, amid moves by some other countries to restrict or suspend its use.

Prime Minister Yoshihide Suga's recent agreement with the CEO of U.S.-based Pfizer Inc. to purchase additional doses of its product was based on the fact that there are no immediate prospects for the practical use in Japan of the British-made AstraZeneca vaccine, which is under review for pharmaceutical approval by Japan's Ministry of Health, Labor and Welfare.

There have been rare cases overseas of blood clots occurring following inoculation with AstraZeneca's vaccine, and moves to restrict the use of the product is expanding in many countries. The possibility of the vaccine not being widely available in Japan has increased, and the government has hastily moved to increase supplies of Pfizer's vaccine.

Before that, the government had signed supply contracts with three companies: Pfizer for 144 million doses, AstraZeneca for 120 million doses, and U.S.-based Moderna Inc. for 50 million doses. Each of the three vaccines requires two shots per person, and for the 110 million people in Japan aged 16 years old or older, about 220 million doses are needed. On the assumption that the three companies' vaccines would be approved, it was calculated that the total would be enough for the entire nation.

However, the situation has since changed because of developments in Europe regarding AstraZeneca's vaccine, where several reports of blood clots after vaccination were received in March, and the European Medicines Agency (EMA) recognized the possibility of "very rare side effects" on April 7. However, the incidence rate is a few in a million, and the EMA and the World Health Organization continue to recommend vaccinations.

However, several countries, including France, have limited the vaccine to people in their 50s and 60s or older, who are at higher risk of developing serious COVID-19 symptoms. The U.K., despite being AstraZeneca's home country, has also recommended other vaccines for those under 30 years old, while Denmark became the first country to announce the complete cessation of the use of the vaccine among the countries that had already put it to practical use.

In Japan, AstraZeneca filed an application for approval of the vaccine with the health ministry in February and submitted additional data from domestic clinical trials in March, but some within the government pointed out that "even if approval is granted, it would have to be limited to the elderly, as is the case overseas." However, the government is planning to inoculate all elderly people aged 65 and over with Pfizer's vaccine.

One member of the ruling Liberal Democratic Party who is familiar with the health ministry and has a strong influence on the ministry's policy decisions, asked, "Who are we going to inoculate (with AstraZeneca's vaccine)?"

The government had agreed to receive 100 million doses of the vaccine from Pfizer by the end of June, but even with the addition of the Moderna vaccine, which is expected to be approved as early as May, it could run out of stock. For this reason, administrative reform minister Taro Kono, who is in charge of the coronavirus vaccine rollout, has asked Pfizer behind closed doors to bring forward its supply of the remaining 44 million doses to no later than the end of September and sought to purchase additional doses to cover the shortage. The remaining doses were initially due to be supplied "within this year." Preparations had been underway to reach an agreement on these plans during Prime Minister Yoshihide Suga's recent visit to the U.S.

The change in Japan's procurement strategy is likely to have an impact on the domestic vaccination plan. While Pfizer's products require ultralow temperature controls, AstraZeneca's products can be refrigerated and are easier to handle. There were hopes within the government that the latter could be widely used for mass vaccinations of the working-age population at workplaces, but the number of vaccination sites will be limited if the country relies solely on Pfizer's vaccine. However, now that the supply is expected to be completed by the end of September, the government intends to announce as early as May how it will proceed with vaccinations after the elderly receive doses.

In the meantime, AstraZeneca has established a system for large-scale vaccine production in Japan in cooperation with a Japanese manufacturer, and the government has invested in this in advance. In the future, attention is likely to be placed on how manufactured vaccines are put to use.

(Japanese original by Ai Yokota, Lifestyle and Medical News Department)