Takeda Seeks Approval For Moderna's COVID-19 Shot In Japan

Takeda Pharmaceutical Co Ltd (NYSE: TAK) has asked regulators to approve the use of Moderna Inc’s (NASDAQ: MRNA) COVID-19 vaccine (mRNA-1273 or TAK-919).

• Takeda filed the New Drug Application to import and distribute the shot. It has earlier said approval could be given in May.
• Takeda will handle about 50 million Moderna doses, beginning in the first half of 2021, pending licensure in Japan.
• Recently, Takeda dosed the first patient in Phase 1/2 study evaluating the safety and immunogenicity of two vaccinations of mRNA-1273 at the 100 μg dose level in Japan.
• Japan kicked off its inoculations in the middle of February using Pfizer Inc’s (NYSE: PFE) vaccine. But, Pfizer doses imported from European factories are in short supply.
• AstraZeneca Plc (NASDAQ: AZN) applied for Japanese approval of its COVID-19 vaccine candidate early in February, and that decision is still pending.
• Additionally, Takeda also handled the approval process and domestic production of about 250 million doses of Novavax Inc’s (NASDAQ: NVAX) vaccine, which entered clinical trials in Japan late last month.
• Price Action: MRNA shares are down 1.8% at $129.9 in premarket trading on the last check Friday, while TAK shares closed 1.5% lower at $17.44 on Thursday.