Having in-licensed a COVID-19 vaccine from Novavax, Takeda will manufacture up to 250 million doses per year from its Hikari, Japan facility, freshly absolved by the US FDA.

In June 2020, the US Food and Drug Administration (FDA) issued Takeda’s Hikari facility – located 40 km southwest of Hiroshima – a warning letter after inspectors identified issues with the plant’s Quality Unit (QU), including concerns about how the firm investigated unexplained discrepancy and batch failures – specifically the detection of “black particles.”

16 months on and the firm said in its Q2 financial results that the FDA has determined that the conditions in the warning letter have been addressed and the letter has been closed out.

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“The FDA has now issued a revised voluntary action indicated [VAI] status to the Hikari manufacturing site with an agreement to maintain a dialogue regarding ongoing commitment,” CEO Christophe Weber told investors last week. “I think it does speak to our strong track record of upholding quality standards and our close collaboration with the FDA throughout this process.”

Weber revealed more good news for the troubled site, stating the plant will be used to support production of COVID-19 vaccine candidate, TAK-019 – a recombinant s-protein vaccine candidate against SARS-CoV-2 adjuvanted with Matrix-M in-licensed from Novavax.

In September, the firm announced a supply agreement with the Government of Japan’s Ministry of Health, Labor and Welfare (MHLW) for 150 million doses of Novavax’ vaccine candidate and has received a government subsidy to build out manufacturing capacity in Hikari.

“We are partnering with Novavax in Japan to develop and manufacture up to 250 million dose per year and commercialize COVID-19 vaccines candidate from our Hikari facility in Japan, where it will be manufactured,” said Weber. “We aim to be in the distribution of these vaccines in the early part of 2022 under the government vaccines program, of course, pending a number of factors, including regulatory approval.”

Takeda has also partnered with Moderna, distributing its vaccine within Japan and has loaned space at its third-party manufacturing party IDT Biologika to support J&J’s COVID vaccine effort.

“Takeda is really keen and is really committed to play a key role in the head to fight the COVID-19 pandemic in Japan,” said Weber. “As you know, as a marketing operational holder for the Moderna COVID-19 vaccine in Japan, we have distributed 50 million dose in Japan and expect to begin importing and distributing an additional 50 million as early as the beginning of 2022.”