Moderna's COVID-19 Vaccine Receives Approval for Emergency Use in Japan
Shots:
- MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity and safety clinical trial
- The interim analysis showed that binding Ab and neutralizing Ab titers were elevated @28days after the second dose in 100% of people vaccinated with two 0.5ml doses of TAK-919 given 28 days apart. The vaccine was well tolerated with no safety signals observed
- The response is consistent with the results from Moderna’s pivotal P-III COVE trial conducted in the US. Takeda plans to begin distribution in Japan imminently
Ref: Takeda | Image: Moderna
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