PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.

Shanghai-based Everest Medicines Ltd. has won exclusive global rights to a set of viral 3C-like (3CL) protease inhibitors from Singapore's national drug discovery platform, the Experimental Drug Development Centre (EDDC), in a deal worth up to $214.5 million.

Shanghai-based Everest Medicines Ltd. has won exclusive global rights to a set of viral 3C-like (3CL) protease inhibitors from Singapore's national drug discovery platform, the Experimental Drug Development Centre (EDDC), in a deal worth up to $214.5 million.

One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.

Stimulating the innate immune system with defective viral genomes (DVG)-based strategy provided broad-spectrum protection against RNA viral infections, including SARS-CoV-2 and other respiratory diseases in animal models, according to a U.S.-led international collaborative study reported in the Nov. 17, 2021, edition of Cell.

While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.

While the world grapples for a clear picture of the Omicron variant and how to handle it, Moderna Inc., Biontech SE and Adagio Therapeutics Inc. stepped out with stock advances, building on momentum from the end of last week, while eyeing 2022 as a launch date against the variant.

With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections.