Pfizer and BioNTech has been granted a temporary emergency use authorisation for its Covid-19 mRNA vaccine, BNT162b2, by the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA). This is the first approval in the world for a Covid-19 vaccine candidate. Pfizer and BioNTech are expecting further regulatory decisions and approvals in the days ahead and claim to be ready to deliver vaccine doses.
The US Government has purchased 650,000 additional doses of Eli Lilly’s neutralising antibody bamlanivimab (LY-CoV555). The $812.5m purchase agreement will see some doses delivered by the end of January. Bamlanivimab has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for treating mild to moderate Covid-19 symptoms in patients, which can progress to severe conditions.
Mesoblast has been granted Fast Track designation for Remestemcel-L by the FDA for treating acute respiratory distress syndrome (ARDS) caused by Covid-19. ARDS is the primary cause of Covid-19 mortality in patients.
Appili Therapeutics announced that it had dosed its first participant in its Phase III trial to evaluate the efficacy of oral Avigan tablets (Favipiravir) to fight the Covid-19 disease. The trial is being conducted across 47 outpatient sites, under the supervision of PRA Health Sciences. Approximately 826 participants will be enrolled into the randomised, double-blind, placebo-controlled study.