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Shionogi applies for COVID-19 vaccine approval, 1st as Japan-made

Photo taken Feb. 25, 2022, shows Shionogi & Co.’s head office in Osaka, western Japan. (Kyodo)

Japanese pharmaceutical firm Shionogi & Co. said Thursday it has applied with the health ministry for approval of its novel coronavirus vaccine.

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

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 jabs.

The recombinant protein-based preventive vaccine is 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.

If approved, it may become an option for those who previously could not receive coronavirus vaccine shots due to allergies or other issues.

According to Shionogi, the new vaccine’s clinical trial for booster shot administration showed that the level of neutralizing antibodies, which help to block virus infection, in patients was around the same as those who have received Pfizer vaccines.

In its clinical trial for their first shots, the neutralizing antibody titer was seen to be statistically much greater than those inoculated with AstraZeneca Plc. vaccine, Shionogi said.

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


Related coverage:

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





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