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September 23, 2021

Coronavirus company news summary – FDA grants emergency approval to Pfizer/BioNTech Covid-19 vaccine booster – Gilead reports positive results from Phase III remdesivir trial

By Chris Lo

Pfizer and BioNTech have received the first US Food and Drug Administration Emergency Use Authorization (EUA) of a Covid-19 vaccine booster. The booster shot of the companies’ Comirnaty vaccine is authorised for people aged 65 years and above and those aged 18 to 64 years at high risk of severe disease or increased risk of serious complications due to regular institutional or occupational exposure to SARS-CoV-2. The booster must be given a minimum of six months following completion of the primary vaccination series.

Gilead Sciences has reported that a three-day course of intravenous (IV) Veklury (remdesivir) led to a statistically significant 87% decrease in the risk of Covid-19-linked hospitalisation or all-cause death by day 28 versus placebo in a Phase III clinical trial in non-hospitalised patients who are at increase risk of disease progression. In addition to this composite primary endpoint, the trial also met the composite secondary endpoint of medical visits related to Covid-19 or all-cause death by day 28. Antiviral drug Veklury has been authorised for temporary use to treat Covid-19 in around 50 countries.

SAB Biotherapeutics has received an additional $60.5m from the US Department of Defense (DoD) to support its DiversitAb Rapid Response Antibody Program for advancing clinical development through licensure and commercial manufacturing of SAB-185, a therapeutic being developed for Covid-19. The grant brings the total funding secured by the company to over $200m since March 2020 to advance the DiversitAb programme. SAB-185 is a polyclonal antibody that is currently in a Phase II/III trial in non-hospitalised patients who have mild-moderate Covid-19 but are at risk of progression.

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