Shots:

• The submission is based on the interim analysis from the ongoing P-I/II trial to evaluate TAK-019/NVX-CoV2373 in patients with COVID-19 which showed a robust immune response, was well tolerated & no serious AEs were observed
• The submission is also based on the 2 P-III (PREVENT-19) trial of NVX-CoV2373 in ~50,000 patients across the US, Mexico & UK that showed 100% protection against mod. and sev. disease, 89.7% & 90.4% efficacy against all symptomatic COVID-19 while 93.2% against VOC and variants of interest & have safety & tolerability profile
• The companies are planning to manufacture TAK-019 at Takeda's facilities in Japan and plan to initiate the distribution in early 2022

Ref: PR Newswire | Image: Takeda