Domestic vaccine - Shionogi large-scale clinical trial: will apply for approval within the year

Recently NHK News on-line reported the following:

国産ワクチン 塩野義が大規模な臨床試験 年度内にも承認申請か

2021年10月21日 17時47分

大阪に本社がある「塩野義製薬」は、開発を進めている新型コロナウイルスの国産ワクチンについて、およそ3000人を対象にした大規模な臨床試験に入ったことを明らかにしました。会社では、年内にも最終段階の試験を始め、安全性や有効性が確認できれば、年度内にも国に承認を申請する考えです。

「塩野義製薬」は新型コロナの国産ワクチンについて、ことし8月から新しい製剤を使って日本人の成人60人を対象に、初期段階の臨床試験を進めてきました。

これまでに安全性に大きな問題はなく、ウイルスの働きを抑える中和抗体の値が上昇したことが確認されたということです。

この結果を受けて、会社は20日から次の臨床試験を始めたことを明らかにしました。

新たな試験では、日本人の成人およそ3000人を対象に、1人につき2回の接種を行い、有効性などを確認します。

また、年内にも最終段階のさらに大規模な臨床試験を始める方針で、この試験でも安全性や有効性が確認できれば、年度内にも国に承認を申請するとしています。

国産ワクチンをめぐっては、塩野義製薬のほか、製薬大手の「第一三共」や熊本の製薬企業、「KMバイオロジクス」なども早期の実用化を目指して開発を進めています。

Translation

Shionogi Pharmaceutical Co., Ltd., headquartered in Osaka, announced that it had entered into a large-scale clinical trial of a domestic vaccine for the new coronavirus that was under development, targeting approximately 3,000 people. The company planned to start the final stage of the test by the end of the year, and if the safety and efficacy could be confirmed, it would apply for vaccine approval from the government by the end of the year.

Since August, Shionogi had been conducting clinical trials of the new corona domestic vaccine in 60 Japanese adults using a new formulation.

So far, there were no major safety issues, and it had been confirmed that the level of neutralizing antibodies that suppressed the action of the virus had increased.

Following this result, the company announced that it had begun its next clinical trial on the 20th.

In a new study, about 3000 Japanese adults would be inoculated twice per person to confirm vaccine’s effectiveness.

In addition, the policy was to start a larger-scale final stage clinical trial by the end of the year, and if the safety and efficacy of this trial could be confirmed, the company would apply to the government for approval within this year.

Regarding domestic vaccines, in addition to Shionogi Pharmaceutical, major pharmaceutical companies such as Daiichi Sankyo, Kumamoto's pharmaceutical company, and KM Biologics were also developing vaccines with the aim of early commercialization.

               It is interesting to note that given Japan’s world class capability in medical research and production, they are late in producing their own vaccines. Japan’s neighbor Taiwan has already started using its domestic vaccine a few months ago.