Shots:

• The approval was based on the interim results from a P-I/II study conducted by Takeda in Japan, multiple studies conducted by Novavax including 2 P-III trials in the US, UK & Mexico along with P-I/II studies in Australia & the US for COVID-19
• The results from the P-I/II study in Japan were positive & consistent with the prior reported trials with no serious AEs & were well-tolerated while safety & efficacy data will support booster immunization including a P-II study conducted by Novavax in South Africa evaluating a booster dose after primary immunization
• Takeda had received funding for the technology transfer and R&D to manufacturing Nuvaxovid at the Hikari facility & will initiate distribution in Japan shortly

Ref: Businesswire | Image: Takeda