Shionogi applies for approval of COVID-19 vaccine, first Japanese-made

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Photo taken February 25, 2022, shows Shionogi & Co. headquarters. in Osaka, Western Japan. (TBEN)

The Japanese pharmaceutical company Shionogi & Co. said Thursday it has applied to the Health Ministry for approval for its new coronavirus vaccine.

It was the first application of a COVID-19 vaccine developed in Japan. Just two days after the ministry granted emergency approval for its oral coronavirus drug Xocova, the first for a domestic drugmaker, Shionogi is now seeking permission to manufacture and sell the recombinant protein-based vaccine.

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The Osaka-headquartered company said the vaccine it has asked the Ministry of Health, Labor and Welfare to approve is for use by adult COVID-19 patients in their first and third shots.

The recombinant protein-based preventive vaccine is of the same type as a COVID-19 vaccine developed by Novavax Inc. and differs from messenger RNA vaccines developed by Pfizer Inc. or Moderna Inc.

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If approved, it could become an option for those who previously couldn’t get coronavirus vaccinations because of allergies or other issues.

According to Shionogi, the clinical trial of the new booster injection vaccine showed that the level of neutralizing antibodies, which help block virus infection, was about the same in patients as in those who received Pfizer vaccines.

In the clinical trial for their first injections, the neutralizing antibody titer was found to be statistically much greater than that inoculated with AstraZeneca Plc. vaccine, Shionogi said.

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Its other Japanese rivals, including Daiichi Sankyo Co. and KM Biologics Co., have also been trying to develop vaccines against the coronavirus.


Related coverage:

Japan gives emergency approval to Shionogi’s oral COVID-19 drug


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