Pfizer and BioNTech are set to seek authorisation from the US Food and Drug Administration for the booster Covid-19 vaccines for usage in individuals aged 16-17 years soon, CNN reported. Currently, booster shots are indicated for use in people aged 18 years and above, six months after the initial dosing regimen. Meanwhile, the US Centers for Disease Control and Prevention has advised all adults to receive booster doses with the emergence of the new SARS-CoV-2 variant Omicron.
Celltrion’s distribution division has entered deals with nine European countries to deliver its monoclonal antibody therapy, Regkirona (regdanvimab, CT-P59), for the treatment of Covid-19. Recently, the European Commission granted marketing authorisation for the drug. Regkirona is intended for use in adult Covid-19 patients who do not need supplemental oxygen but are at high disease progression risk. The initial shipment of 50,000 doses will be made to Europe this year while Celltrion is holding discussions with 47 other countries.
Immunome has filed an Investigational New Drug application with the US Food and Drug Administration to commence clinical trials of its three-antibody cocktail, IMM-BCP-01, to treat Covid-19. Acting on the non-overlapping regions of the Spike protein, IMM-BCP-01 induces multi-modal activity in pre-clinical analysis. In in vitro testing, the antibody combination showed the potential to lower viral load in lungs of Covid-19-infected hamsters and could also neutralise present, as well as former, variants of concern.