As Moderna faces questions about contaminants found in its COVID-19 vaccines in Japan, the company’s distribution partner in the country, Takeda, is moving forward on its plans with another COVID vaccine developer.
On Monday, Takeda said the Japanese government has agreed to purchase 150 million doses of the Novavax shot that it will produce. Takeda and Novavax previously struck a licensing and production deal covering the country.
The Novavax shot remains in development, and the partners aim to start the rollout in Japan early next year. The government's purchasing agreement is subject to regulatory approvals.
While Takeda and Novavax struck their COVID vaccine partnership more than a year ago, the latest announcement helps to clarify timelines and plans.
Under the agreement, Novavax is transferring technologies to allow Takeda to manufacture the vaccine antigen. The partners will combine the antigen with an adjuvant, Matrix-M, provided by Novavax, in the fill/finish stage of production.
In the original pact, the companies said they hoped to have the capacity to produce 250 million doses per year. Takeda is handling clinical trials, regulatory submissions and distribution in Japan.
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The news comes as Takeda is embroiled in controversy as the country’s distribution partner of the Moderna vaccine. Over the past two weeks, contaminants have been discovered in Moderna vaccine vials in Japan, forcing the suspension of batches of the shot.
Last week, Moderna identified the foreign material as stainless steel, which likely entered through friction from two pieces of machinery incorrectly installed on a production line. Moderna traced the problem to Rovi Laboratories, the Spanish manufacturer which does fill/finish work for the vaccine.
Other contaminants, such as rubber stopper material, also have been discovered recently in Moderna vials in Japan. This material also could have entered during manufacturing, Takeda said.
Two Japanese men, aged 38 and 30, died after receiving their second Moderna doses from a lot later discovered to be contaminated. Health officials in Japan and the U.S. don’t believe that the contaminants found in the vials could have caused the fatalities. There have been no other reports in Japan of unusual side effects among others who have received the Moderna vaccine from the lots in question.
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By taking control of a large portion of the manufacturing of Novovax’s COVID-19 vaccine, Takeda could build confidence in the shot in Japan, giving it a better chance for widespread adoption.
Novavax had hoped to secure FDA approval for its shot this summer. But manufacturing and supply issues have pushed its target for regulatory submission from May to the fourth quarter of this year. Last month, Novavax hired industry veterans Nasir Egal, from Sanofi, and Jim Kelly, from Supernus, to help push the shot to the finish line. Egal is the new head of quality control while Kelly has taken over as CFO.