As part of a previously announced deal with Novavax, Takeda is establishing the capability to manufacture TAK-019 – known outside Japan as NVX-CoV2373 – at its facilities in Japan and aims to begin distribution early net year.
Novavax is licensing and transferring manufacturing technologies to enable Takeda manufacture the vaccine antigen and it is supplying the adjuvant, Matrix-M, required for fill/finish production.
Takeda will be responsible for the clinical trials, regulatory submissions and the roll-out of TAK-109 in Japan.
The pharma company said its efforts to transfer technology, establish production facilities and distribute Novavax’ vaccine candidate in Japan are supported by the country’s Ministry of Health, Labor and Welfare (MHLW) under its supplementary budget for emergency maintenance associated with the vaccine production system.
Contaminated COVID-19 batches, third person dies in Japan following inoculation from recalled lot
While Takeda is advancing its plans with Novavax, its COVID-19 vaccine partnership with Moderna is firmly in the spotlight. On August 26, Takeda announced the suspension of three Moderna COVID-19 vaccine lots in light of reports from Japanese vaccination sites indicating the presence of foreign particulate substances in vials of the vaccine.
Moderna’s Spanish manufacturing partner, ROVI Pharma Industrial Services Ltd, subsequently identified the foreign matter as stainless steel from production equipment, the particles most likely came into the vials during the manufacturing process. Takeda then initiated a recall of those lots, which contained about 1.63 million doses.