TOKYO -- Japanese vaccine makers are racing to release COVID vaccines next year as they anticipate new virus variants and further outbreaks.

KM Biologics, a Meiji Holdings subsidiary, said on Wednesday that it is aiming for the release of its inactivated vaccine for use as booster shots next year. The Kumamoto-based company began a Phase 2/3 trial last week.

Inactivated vaccines have been used for influenza and other infectious diseases for years. An initial clinical trial on KM Biologics' vaccine has shown that it has fewer side effects than those made by Pfizer, Moderna and AstraZeneca, Toshiaki Nagasato, president of KM Biologics said during the two-day Nikkei-FT Communicable Diseases Conference in Tokyo.

KM Biologics is planning to prove the vaccine's efficacy and safety as a booster as well as for those under the age of 12, a group for whom COVID vaccinations have not yet been approved in Japan.

The company has yet to conduct a large-scale global Phase 3 trial, which is planned for 2022-2023. To make the vaccine available next year, the government has to give it a conditional approval, which it has never done for vaccines.

COVID vaccines was a key topic of discussion at the 8th Nikkei FT Communicable Diseases Conference in Tokyo on Oct. 27. (Photo by Kai Fujii)

Japan relies on the U.S. and Europe for its COVID vaccines and its failure to make its own quickly has become a major political issue.

Vaccine production requires large manufacturing infrastructure, which cannot be created quickly or easily. Vaccines have relatively short shelf-lives and are difficult to stockpile on a long-term basis. Without the capability to produce vaccines domestically, there is always a risk of a pandemic wreaking major havoc on the economy like it did last year.

Daiichi Sankyo, a Tokyo-based cancer drugmaker, said that it will start a Phase 2 trial on its messenger RNA-based vaccine next year, aiming to put it in the market within fiscal 2022, which will start in April.

Speaking at the conference, CEO Sunao Manabe said its mRNA vaccine is different from those made by Pfizer or Moderna as it only targets a smaller part of the virus protein called the receptor binding domain, instead of the entire spike protein, to trigger a reaction that creates immunity.

Shionogi, another Japanese vaccine maker, aims to make its vaccine available by the end of March 2022. The Osaka-based company is developing a "recombinant protein vaccine," which uses genetically modified insect cells to produce copies of the COVID-19 spike protein. A similar technology is being employed by Novavax, Sanofi and GSK in their own vaccine development.

Shionogi began a Phase 2/3 trial this month and plans to conduct a global Phase 3 trial simultaneously by the end of December.

Shionogi CEO Isao Teshirogi said the plan depends on the vaccine receiving conditional approval from the government. "The system of 'conditional approval' does exist in Japan. The question is whether it will be applied to vaccines," he said.

The number of COVID infections has dropped sharply in Japan after more than 70% of the nation's population became fully vaccinated. The seven-day moving average of new infections now stands below 300.

"Several companies are developing COVID vaccines in Japan, but none has made it to the market," said Norio Tamura, head of Shionogi's vaccine business department. "There wasn't infrastructure or technology for responding to an emergency," he said. "The country needs to be redesigned so it will be ready for such an emergency."