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.
Image: Stock Photo Secrets
“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.