By KANAKO TANAKA/ Staff Writer
November 2, 2021 at 17:15 JST
A factory in Gifu Prefecture that manufactures a new vaccine for COVID-19 for drug maker Shionogi & Co. (Provided by Shionogi & Co.)
Drug maker Shionogi & Co. on Nov. 1 said it will start its final stage of clinical testing for a new COVID-19 vaccine by the end of November.
The company aims to put the new vaccine to practical use by March 2022.
“It is game time for us in terms of how to make (the vaccine) a commercial reality in the second half of the fiscal year," Isao Teshirogi, president of Shionogi, said at a news conference on Nov. 1 to announce the company’s midterm earnings.
Teshirogi said the new vaccine under development “is extremely good.”
In addition, Shionogi hopes the new vaccine will be approved for use as a booster shot.
The company started clinical testing in December 2020.
But because the amount of neutralizing antibodies that prevents infection did not increase fully, the company changed an adjuvant to mix in the vaccine and started redoing its primary phase clinical testing from July.
From late October, the company started the next phase, which is clinical testing that targets 3,000 people in Japan.
To submit an approval request to the central government, it requires a final phase clinical testing on an even larger scale.
Starting from November, the company is expected to start comparing the effectiveness of the new vaccine under development to that of a placebo in Asia.
In Japan and abroad, the company is also expected to start comparing the effectiveness of the new vaccine under development to that of other vaccines that have already been approved.
At the Nov. 1 news conference, the company also revealed that it has struggled to secure enough patients to conduct final phase clinical testing for its COVID-19 oral antiviral drug, because the pandemic has eased in Japan.
The company therefore will open the clinical trial to subjects in Singapore, South Korea and Britain and conduct clinical testing on up to 2,000 people, hoping to submit an approval request to the central government by the end of the year as scheduled.
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