Moderna Phase III COVID-19 Vaccine Plan To Enroll 30,000 Patients
The company finalized the Phase III program based on feedback from the US FDA and plans to start the study in July. With a 100 µg dose, Moderna says it can manufacture 500 million doses a year.
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Neutralizing antibodies were seen in all 45 people injected across three dose levels in the first-in-human study. The middle dose of 100mcg will be tested in the company’s Phase III trial starting 27 July.
Pfizer and BioNTech appear to have the upper hand on mRNA rivals Moderna, but Phase III results will be the real test.
Recruiting the right patient population for Phase III trials of COVID-19 vaccines will be a key factor in how fast any candidate can come to market. The challenge, which will likely mean enrolling patients who often are underrepresented in trials, is keeping Moderna's Chief Medical Officer up at night. The company also talked vaccine distribution, what it feels it owes the US government for its financial support, and pricing of its potential mRNA vaccine on a recent New York Academy of Sciences webinar.