In an interview yesterday during the Morgan Stanley Healthcare Conference, Moderna (MRNA +4.6%) CEO Stéphane Bancel said its large-scale 30K-subject Phase 3 study had enrolled 23,497 participants as of Friday, September 11. A “significant” number have received the second shot so the base plan for data readouts is November with an upside of next month.
The enrollment rate has been slowed down to ensure robust diversity which was only 27% of target as of September 11.
Will transition into a pediatric setting after the FDA signs off on the safety profile in adults.
Neutralizing antibody responses similar in young adults, those aged 56-70 and 71+.
Production plan remains a firm 500M doses in 2021 with an upside to 1B. GMP space is not a problem. Additional capital equipment should be delivered soon. Unclear, at this time point, whether it can procure enough raw materials to make 1B doses next year. 800M doses may be more realistic.
Vaccine is stored at minus 20 degrees Celsius (many vaccines are minus 17). No on-site dilution required.
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