Photo/Illutration A sample of Daiichi Sankyo Co.’s COVID-19 vaccine (Provided by Daiichi Sankyo Co.)

Japan’s first domestically produced vaccine for the virus that causes COVID-19 has been cleared for regulatory approval.

A health ministry panel of experts on July 31 endorsed the plan for Daiichi Sankyo Co. to begin producing and distributing the vaccine, which creates immunity for the conventional strain of the virus.

However, the product will not be used for general inoculations planned from September because the health ministry’s priority is the Omicron strain’s XBB subvariant. 

The government will procure vaccines specific to the Omicron strain from U.S. pharmaceutical companies Pfizer Inc. and Moderna Inc.

Nevertheless, one clinical virology expert sees the vaccine as an important step for a Japanese drugmaker.

“The development of a vaccine for the conventional strain needs to be seen as a step toward the manufacturing of a vaccine for the Omicron strain,” said Tetsuo Nakayama, a specially appointed professor at Kitasato University’s Omura Satoshi Memorial Institute.

Daiichi Sankyo has been working on a vaccine for the Omicron strain.

The drugmaker took the same path as Pfizer and Moderna in developing its current vaccine based on messenger RNA--one of several possible techniques.

Clinical trials for safety and efficacy were carried out in Japan. The drug was tested on participants aged 18 or older, who have been vaccinated twice with conventional products.

Meanwhile, the panel of experts discussed a vaccine developed by Shionogi & Co., which also targets the conventional strain, but postponed a decision because clinical trials failed to establish the vaccine’s efficacy.

Japan began inoculating people against the virus in spring 2021 using a Pfizer vaccine. It took only about a year for Pfizer and Moderna vaccines to reach the market.

The workflow for vaccine development is well established. Recent examples involve a disease with similar symptoms to COVID-19, the severe acute respiratory syndrome, better known as SARS. Moreover, messenger RNA was an established route to obtaining an immune response.

However, domestic drugmakers lagged their foreign rivals.

Daiichi Sankyo, for example, began clinical trials for its vaccine in March 2021, when a Pfizer vaccine was already in use in Japan.

To Nakayama, it is a case of better late than never.

“It is important to accumulate know-how without depending on overseas vaccines in preparation for the next pandemic,” Nakayama said.

(This article was compiled from reports by Mirei Jinguji, Kazuhiro Fujitani and Kazuya Goto.)

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