What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.
CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
LONDON – A further U.K. real-world study of COVID-19 vaccines has found a single dose dramatically reduces the chances of the most elderly and frail being admitted to the hospital as a result of serious infection.
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
LONDON – The SARS-CoV-2 variant of concern that caused a wave of infection in Manaus, Brazil, in December and January has been found to be both more transmissible and to evade immunity conferred by prior natural infection with the virus.
With several more emergency use authorizations (EUAs) across the globe, COVID-19 efforts to flatten the emerging variants with cocktail therapies and tweaked vaccines are frantically underway. BioWorld has tracked 884 therapeutics and vaccines that have entered development for the deadly SARS-CoV-2 virus since it first emerged more than a year ago, and the U.S. government has now provided EUAs to three vaccines and six therapies.
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