Pfizer and BioNTech have secured priority review designation from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of their Covid-19 vaccine in people aged 16 years and above. The BLA’s rolling submission was concluded in May this year, and the FDA is expected to provide a decision on the vaccine’s approval by January next year.

Celltrion Group’s regdanvimab (CT-P59) has shown a robust neutralising effect in an in vivo efficacy study against the Delta variant, which was first detected in India and is now quickly spreading globally. When given at a clinically relevant dose, the drug candidate had a 100% survival rate from Covid-19 versus 0% with placebo. A therapeutic regdanvimab dosage also decreased the viral load and inflammation in the lungs when compared with controls that were not treated.

The African Union Member States is to begin receiving around 25 million doses of Covid-19 vaccines donated by the US Government, which committed in May to share 80 million doses worldwide. Initially, one million Johnson & Johnson Covid-19 vaccine doses will be delivered to Burkina Faso, Djibouti and Ethiopia. Overall, 49 African countries will receive a total of approximately 25 million doses in the next few weeks via COVAX.