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

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.

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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