In recent weeks, Moderna has disclosed deals and negotiations with major buyers of vaccines against the SARS-CoV-2 coronavirus. The US government has agreed to buy 100 million doses of mRNA-1273, and secured an option on up to 400 million more vials, while the European Commission is in talks to access up to 160 million shots.
Now, Moderna is working with Takeda to bring mRNA-1273 to the Japanese market. Moderna and the Japanese Ministry of Health, Labour and Welfare are in negotiations over a deal for 40 million doses.
If the deal goes through, Takeda will handle distribution of the 40 million doses in Japan, its home market. The distribution agreement would further cement Takeda’s status as a key component of the effort to vaccinate the Japanese population against the coronavirus.
In early August, Novavax granted Takeda a license to manufacture and commercialize its COVID-19 vaccine in Japan. Based on assumptions from Novavax, Takeda estimated it would have the capacity to make 250 million doses of the NVX‑CoV2373 vaccine per year.
Japan has a population of around 126 million, suggesting Takeda’s NVX‑CoV2373 capacity could be sufficient to produce a two-dose regimen for everyone in the country who needs vaccinating.
However, it remains possible that NVX-CoV2373 will fail in clinical development, depriving Japan of the anticipated 250 million doses a year, and likely that other vaccines will come to market before the Novavax candidate.
Novavax initiated the phase 2 portion of its phase 1/2 clinical trial in mid to late-August. A phase 2b trial of the vaccine got underway in South Africa around the same time. Novavax is set to work with the UK government on a phase 3 trial starting in the third quarter.
The timeline puts Novavax a little way behind Moderna and the other frontrunners in the race to develop a COVID-19 vaccine. Moderna began a phase 3 trial of mRNA-1273 in late July.
That start date makes Moderna part of a small group of vaccine developers with a chance of bringing a COVID-19 prophylactic to market this year. Pfizer and BioNTech have expressed hopes of filing for approval of their mRNA vaccine in October. It is also feasible that AstraZeneca may have the data to support a filing for approval of its viral vector prospect in some markets this year.