TOKYO -- Japanese drugmaker Shionogi plans to increase production capacity for its coronavirus vaccine candidate, aiming to turn out enough vaccines for 30 million people per year by the end of 2021, as competition intensifies to develop COVID-19 treatments, Nikkei has learned.
Shionogi will increase capacity at its plant by more than tripling its previous capacity by adding manufacturing equipment. It plans to carry out all phases of production, including procurement of materials, in Japan.
The Japanese government also intends to procure coronavirus vaccines from overseas. But increasing domestic production capacity will reduce the risk of relying solely on imports.
Shionogi is trying to develop a recombinant protein vaccine for COVID-19 using BEVS, or the baculovirus expression vector system, a technology held by subsidiary UMN Pharma. BEVS creates vaccines from insect cells using genetic information from the virus.
The drugmaker plans to produce a candidate vaccine this month and aims to start clinical trials by November. The company will begin supplying a limited amount of the vaccine to medical sites around Japan by January 2021 at the earliest. Once the vaccine is approved by regulators, Shionogi hopes to put it on the market by the fall of 2021.
Shionogi's partner factory will mass-produce the vaccine. Initially, the plan was to turn out vaccines for about 10 million people annually, although the number will vary depending on the effective dosage and how many times it must be administered.
The company said that by adding equipment, annual production of the vaccine can be increased to treat 30 million people by the end of 2021. How much of the vaccine it will actually produce, however, will be determined at a future date, depending on the development process and the course of the pandemic.
Shionogi’s initial plan included a capital investment of about 10 billion to 20 billion yen ($93 million to $186 million). The company had also considered participating in a government subsidiary program that would cover supply chain costs.
The amount of additional investment required for the extra equipment has yet to be determined. The drugmaker is still in talks with government agencies over the issue.
Competition to develop a coronavirus vaccine is heating up, with companies in the U.S., Europe and China leading the charge. Moderna of the U.S. has started clinical trials for a vaccine and plans to make up to 1 billion doses per year, while British drugmaker AstraZeneca, together with the University of Oxford, aims to supply as many as 2 billion doses a year.