Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan

May 21, 2021 Auto Bot approval, Japan, Moderna, regulatory, Vaccine 0

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

Click here to­ read full press release/ article | Ref: Takeda | Image: The Japan Times

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