Moderna Inc.’s and Pfizer Inc.-Biontech SE’s COVID-19 bivalent boosters could be coming to the U.S. in the first week or so of September – even though the U.S. FDA just received the completed emergency use authorization (EUA) requests for the vaccines this week. The CDC is already taking pre-orders from providers, states and other jurisdictions for the yet-to-be authorized booster doses as part of its fall-winter booster campaign strategy. It also scheduled a Sept. 1-2 meeting of its Advisory Committee for Immunization Practices, signaling that it expects the FDA to grant the EUAs by the end of August.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Beigene, Bristol Myers Squibb, Foghorn, Iecure, Jaguar, K36, Merck, Northwest, Synlogic.
While other COVID-19 vaccine makers are developing bivalent boosters comprising the original SARS-CoV-2 strain and an omicron variant, Russia’s Gamaleya National Research Center of Epidemiology and Microbiology is trekking a different course. Leaving behind the ancestral strain, Gamaleya’s next generation of the Sputnik V vaccine has been specifically adapted against delta and omicron variants of the coronavirus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Adjutor, Ascletis, Bavarian Nordic, Dynamicure, Gilead, Minerva, Mundipharma, Novavax, Ocelot, Otsuka, Pfizer, Pharvaris, Takeda, Travere, Veru.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABVC, Amniotics, Belite, Cue, Kronos, Novo, Resverlogix, Santhera, Tonix, Vaderis, Xortx.
It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aarvik, Almac Discovery, Antisense, Avenge, Emerald, Emtora, Innoviva, La Jolla, Larkspur, Lytic Solutions, Moderna, Nighthawk, Nrx, Panther, Relief, Skye, Vaderis, Verve and Zyversa.
RSS
