COVID Quick Takes: Moderna completes SpikeVax submission for full approval
Plus: Brii’s Phase III readout, approval Down Under for Vir, and updates from Pfizer-BioNTech, J&J
Moderna Inc. (NASDAQ:MRNA) has completed a regulatory submission that could make its SpikeVax the second mRNA vaccine to gain FDA’s full approval to treat COVID-19. SpikeVax has been available under an emergency use authorization since December 2020; Moderna began the rolling submission of its BLA in June. Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) received full approval of their Comirnaty vaccine on Monday.
BRII-196/BRII-198, a mAb combination from Brii Biosciences Ltd. (HKEX:2137), reduced the combined risk of hospitalization and death by 78% compared with placebo in 837 non-hospitalized, high-risk patients enrolled in NIH’s Phase II/III ACTIV-2 study. The Shanghai-based company went public on the Hong Kong stock exchange in July. ...