With COVID vaccine on the way, Daiichi Sankyo builds Japan's first mRNA plant: report

Less than four weeks after submitting an application for approval of its mRNA COVID-19 vaccine candidate in its home country, Daiichi Sankyo appears to be setting up a way to manufacture the shot in Japan.

The company is outfitting a plant in Kitamoto, an hour northeast of Daiichi’s headquarters in Tokyo, to produce the shot, according to Japanese news outlet Nikkei Asia.

Daiichi confirmed the report saying "production equipment has been installed" at the plant.

The Kitamoto facility would become the first mRNA vaccine plant in the country and would be able to produce 20 million doses per year by 2024. Plans call for a production wing to be added by 2027 that would be government-funded, Nikkei Asia reported.

Daiichi’s vaccine candidate, DS-5670, increased neutralizing antibodies to a higher level than mRNA shots from Moderna and Pfizer/BioNTech when provided as a booster, the company said in November 2022 when it reported results of a phase 1/2/3 trial.

The study included more than 5,000 adults who had received their primary series from Moderna or Pfizer. DS-5670 was designed to combat the original coronavirus strain. The company also is working on an omicron-adapted booster. Daiichi also has an ongoing trial testing DS-5670 as a two-shot primary series.

Daiichi said on Wednesday that it expects a decision on the shot in FY 2023.

There is competition within the country to develop a COVID vaccine. Last year, Shionogi revealed trial results that showed its recombinant protein vaccine candidate S-268019 worked as well as Pfizer’s Comirnaty booster. Last November, Shionogi made waves when it won approval in Japan for its oral antiviral COVID treatment, which will compete with Pfizer’s Paxlovid and Merck’s Lagevrio.

In addition, KM Biologics plans to seek approval by June for its vaccine candidate KD-414, which uses an inactivated form of the virus. The company also has lined up production capacity of 20 million doses annually at a plant in Kikuchi, in southwest Japan.

Daiichi’s move comes a month after Moderna—one of the world’s top two producers of mRNA COVID vaccines—made its first acquisition in the company’s 12 years, purchasing small Japanese DNA manufacturer OriCiro Genomics for $85 million.