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The FDA told Invivyd that one Phase II/III randomized, double-blind, placebo-controlled trial evaluating mAb efficacy could support a BLA submission for VYD2311 in people ages 12 and older weighing at least 40kg (88 lbs), including immunocompromised people, subject to agreement on safety database size and a full protocol review.

Injectable formulations require correct site rotation, appropriate storage, and product-specific missed-dose protocols as detailed in the patient information leaflet

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