Japan Orders 150 Million Takeda-made Novavax Doses

13.09.2021 - Japanese drugmaker Takeda has clarified its plans to produce and distribute the Novavax Covid-19 shot in the country, if and when it is approved. After several delays, in its last announcement the US biotech said it planned to apply to the US Food and Drug Administration (FDA) for Emergency Use Authorization in this year’s fourth quarter.

Following three deaths that occurred shortly after inoculation with the Moderna vaccine, Japan reportedly is reconsidering plans to order more doses from the US biotech, despite having funded some of its development.

Earlier this year, Takeda and Novavax signed a licensing and production deal for the vaccine in Japan, and Takeda has now revealed that the Japanese government has agreed to purchase 150 million doses. Rollout has been penciled in for early 2022, pending regulatory approval.

Takeda is handling clinical trials, regulatory submissions and distribution for Novavax in Japan, and the companies said previously they hope to have sufficient capacity to produce 250 million doses annually.

As part of the deal, Novavax is transferring its technology to Takeda to enable manufacture of the vaccine antigen. The two companies will then combine the antigen with Novavax’s Matrix-M adjuvant at the fill & finish stage of production.

Third death after Japanese vaccine dose

A third person in Japan is now reported to have died after receiving a second dose of Moderna’s Covid vaccine. All three were men – two in their 30s, one in his 40s. The doses they received did not belong to the lot number confirmed to be contaminated with metal or rubber particles but were manufactured on the same production line at the same time.

 Altogether 1.63 million doses were found by Japanese health workers to be contaminated with particle matter. While Takeda has responsibility for distributing the vaccine in Japan, the affected vials were filled & finished at the Grenada, Spain, plant of Moderna’s CDMO partner Rovi.

When announcing the suspension of distribution, Moderna and Takeda identified the contaminant as stainless steel, which they said is routinely used in heart valves, joint replacements, metal sutures and staples. “As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” the companies said.

The chances are low that foreign objects found in Moderna’s vaccine would cause anaphylaxis, a strong allergic reaction, the Japanese Society for Vaccinology said. All of the deaths came within three days of the inoculation, while allergic reactions to metal take time to be exhibited. The society called on authorities to secure safety by thoroughly managing related processes, from manufacturing to shipments, and conducting checks before vaccinations.

Japan’s health ministry likewise said the deaths were unlikely to have been caused by the contaminated injection fluid.  So far, Japan has approved three Covid-19  vaccines, made by Pfizer/BioNTech, Moderna and AstraZeneca.

The European Medicines Agency (EMA) meanwhile has said it is investigating the contamination incident involving the manufacturing of Moderna Covid-19 vaccines and linked to Spain and will assess whether the recall of certain lots will impact EU supply.

Author: Dede Williams, Freelance Journalist