Shionogi Says Study Found Covid-19 Shot Effective and Safe

(Bloomberg) -- Japanese drugmaker Shionogi & Co. said its experimental Covid-19 vaccine was found safe and effective in a study, creating an indigenous supply source for the Asian nation that is racing to complete a booster drive in hopes of curbing future outbreaks.

The recombinant protein-based vaccine that was being tested as a booster shot met its primary endpoint in the Phase 2/3 trials, Osaka-based Shionogi said in a statement Friday announcing the interim report's findings. There were no serious treatment-related adverse events, deaths or adverse events of special interest, it said.

The data support regulatory approval of the vaccine that could bolster the Japanese government's efforts to tackle the virus that has already infected more than five million people in the country and killed more than 24,000. The world's third-largest economy currently relies on shots from Pfizer Inc. and Moderna Inc. for the bulk of its supplies.

Shionogi said it has been in consultations with the Pharmaceuticals and Medical Devices Agency, or PMDA, since last month to seek regulatory approval in Japan. “We will continue to consult closely with the Ministry of Health, Labor and Welfare, PMDA and other organizations based on the results from these pivotal clinical trials,” it said in the statement.

The drugmaker plans to start commercial production of the vaccine from May, Chief Executive Officer Isao Teshirogi told reporters over a media call Friday.

Slow Start

Japan began giving booster shots in December, starting with health care workers and the elderly. It has since expanded the program to everyone aged 12 and older. While the country's immunization level is one of the highest among developed nations, its booster rate lagged after getting off to a slow start. Only about 21% of the population has received a third shot, according to the Bloomberg Vaccine Tracker, even as an unprecedented virus wave sweeps the country forcing the government to extend curbs for Tokyo and 17 other regions.

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The results come a little over two months after Shionogi announced plans to conduct a placebo-controlled trial of the vaccine in Vietnam, with an aim to expand it to the Philippines and other Southeast Asian nations. The approach, which requires some participants to go unprotected despite the existence of effective vaccines, is generating mounting criticism in the scientific community on ethical grounds.

Uphill Battle

Pharmaceutical companies trying to develop Covid shots are finding trials an uphill battle since many advanced economies are already highly vaccinated. That's led drugmakers to seek out unvaccinated participants in developing nations, where immunity is low and the virus is still active.

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The data released Friday will help allay concerns around Shionogi's vaccine trials in other Asian countries. The company also plans to transfer vaccine-production technology to Vietnam, allowing the government to manufacture doses locally for its citizens.

Shionogi has also filed to obtain approval for its Covid pill in Japan, becoming the first local company seeking to provide a therapy for the viral illness in the domestic market.