Pfizer Corona Vaccine Application for Approval in Japan – will have decision at the earliest in February

Recently NHK News On-line reported the following:

ファイザー コロナワクチン 日本で承認申請 早ければ2月に結論

2020年12月18日 19時11分

 アメリカの製薬大手ファイザーは、新型コロナウイルスのワクチンの日本国内での使用に向け、18日厚生労働省に承認を求める申請を行いました。新型コロナウイルスのワクチンをめぐって、国内で承認申請が行われるのは初めてで、早ければ2月中にも承認するかどうか結論が出る見通しです。

ファイザーはドイツの企業と共同で新型コロナウイルスのワクチンを開発し、アメリカやイギリスなどでは今月から接種が始まりました。

日本政府も来年6月末までに6000万人分の供給を受けることで基本合意しています。

ファイザーによりますと、これまでに世界各国で行った臨床試験の最終的な効果の分析では95％の有効性が見られ、人種による目立った違いは確認されなかったということです。

このため、ファイザーは、18日、日本国内での使用に向け、厚生労働省に承認の申請を行いました。

国内で新型コロナウイルスのワクチンの承認申請が行われるのは初めてで、審査の手続きを大幅に簡略化する「特例承認」の適用を目指しているということです。

Translation

Pfizer, a major American pharmaceutical company, had applied for approval from the Ministry of Health, Labor and Welfare on the 18th for the use of the new coronavirus vaccine in Japan. This was the first time an application for approval was submitted in Japan for a new coronavirus vaccine, and it was expected that whether or not it would be approved could be decided as early as February.

Pfizer had developed a new coronavirus vaccine in collaboration with a German company, and vaccination had started this month in the United States and the United Kingdom.

The Japanese government had also reached a basic agreement to receive a supply for 60 million people by the end of June next year.

According to Pfizer, an analysis on the final effects of clinical trials conducted around the world had shown a 95% efficacy with no noticeable racial differences.

Therefore, on the 18^th Pfizer applied for approval to the Ministry of Health, Labor and Welfare for use in Japan.

This would the first time that an application for approval of a new coronavirus vaccine was submitted in Japan, and the aim was to apply a "special approval", which might greatly simplify the vetting procedure.

              It seems that a mass vaccination program in Japan could have a slow start compared with other developed countries. Perhaps it is waiting for the development of its own vaccine. For the news on what vaccines the Japanese are developing, please see my blog dated 13th December 2020.