Company coronavirus news summary – Pfizer moves one step closer to emergency approval in the US – Moderna does adolescents into its Phase II/III study

11 December 2020 (Last Updated December 11th, 2020 09:12)

11 December 2020 

Pfizer and BioNTech announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee has offered 17 to 4 votes in support of emergency use authorisation (EUA) of BNT162b2, the companies’ Covid-19 mRNA vaccine candidate. The FDA’s final decision on emergency approval is expected in the next few days.

Inovio and Advaccine Biopharmaceuticals announced the first dosing of a subject in their  Phase II clinical trial of INO-4800, a Covid-19 DNA vaccine candidate, in China. The Phase II clinical trial is independent of the ongoing INNOVATE Phase II/III clinical trial of INO-4800 in the US.

Moderna announced the first dosing of its Covid-19 vaccine, mRNA-1273, v in adolescent participants aged between 12 and 18 years in its Phase II/III study.  The study is being carried out in collaborate with the US Biomedical Advanced Research and Development Authority (BARDA) and aims to evaluate the safety and immunogenicity of the vaccine in younger people.

Pharming Group has enrolled its first patient into a randomised, open label, parallel group, controlled, pilot clinical trial among 120 hospitalised Covid-19 positive patients. The patients will be administered RUCONEST to prevent them progressing to severe disease. The trial is initially being conducted at the Valley Hospital in New Jersey but will be extended to patients in other centres across the US.