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.
Three people in Japan died after being inoculated with one of those lots: 3004734. The deaths remain under investigation, and the Japanese health ministry said it has yet to establish any causal relationship with the vaccine.
The death of the third person was confirmed yesterday by the Japanese officials. The 49-year-old man died on August 12, one day after getting his second shot of the Moderna vaccine. His only known health issue was an allergy to buckwheat, the officials said.
Two other men, aged 30 and 38, also died in August within days of getting their second Moderna shot, according to the authorities.
In a joint statement last week, Moderna and Takeda stressed that there was no evidence that the two deaths following administration of the Moderna COVID-19 vaccine - from lot 3004734 - were in any way related to the shot. “The relationship is currently considered to be coincidental.”
The rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product, they said.
“Metallic particles of this size injected into a muscle may result in a local reaction but are unlikely to result in other adverse reactions beyond the local site of the injection,” added the companies.