Coronavirus Update: Moderna And Pfizer Respond To Vaccine Trial Transparency Demands
Plus: Amgen Helps Lilly With Antibody Manufacturing
Moderna led by releasing the trial protocol for its COVID-19 vaccine study, followed by Pfizer, as industry faces demands for transparency.
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Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.
Following last month’s data showing reduced hospitalization risk with single neutralizing antibody therapy, Lilly now has data showing a two-antibody combo reduces COVID-19 viral load significantly.
Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.