Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Annexon, Apellis, Concert, Eli Lilly, Engrail, GSK, Kazia, Merck, Moderna, Nascent, Newron, Ridgeback, Seres, Sobi.
Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Affibody, Alx, Aurinia, Biogen, Biothera, Incannex, Inmagene, Intercept, Merck, Nicox, Novo Nordisk, Olix, Sorrento, Tranquis.
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
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