Moderna Unveils COVID-19 Booster Data As Pfizer Goes Before Skeptical Regulators
Debate About Extent Of Waning Immunity
Moderna is hot on the heels of Pfizer with booster data for its COVID-19 vaccine, and could benefit from its rival being first to face potential skepticism from the US FDA over booster data for its vaccine.
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The companies announced data from their Phase II/III study in children aged 5-11 and intend to take them to regulators to expand Comirnaty's authorization; also, an expert panel advising India's drug regulator endorsed plans for a Phase III trial of a single-dose Russian vaccine, Sputnik Light, and vaccines from other Indian firms progress.
If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.
The VC firm is making the most of a surge of capital from new and established investors who believe in the promise of European biopharma start-ups.