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October 5, 2021updated 06 Oct 2021 10:01am

Coronavirus company news summary – EMA committee backs Pfizer-BioNTech Covid-19 vaccine booster – SAB Biotherapeutics’ antibody treatment begins Phase III trial

By Chris Lo

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed a proposal to administer a booster dose of the PfizerBioNTech Covid-19 vaccine in adults. The committee recommended the third dose six months after the second shot in individuals above 18 years of age. The European Commission (EC) will now review the recommendation. If the EC approves an update of the jab’s conditional authorisation to include booster shots, the decision will be implemented across all 27 EU member states.

SAB Biotherapeutics has commenced the Phase III section of the ACTIV-2 trial to evaluate the efficacy and safety of antibody therapeutic candidate SAB-185 for treating non-hospitalised Covid-19 patients. The company has already dosed the first patient. In the trial, around 600 participants will receive the investigational agent and 600 subjects will be given an active comparator. ACTIV-2 is a large study investigating the safety and efficacy of a range of Covid-19 therapeutics, and is being led by the US National Institute of Allergy and Infectious Diseases (NIAID).

GlaxoSmithKline has entered into an agreement to deliver 10,000 doses of sotrovimab, its Covid-19 monoclonal antibody therapy developed in partnership with Vir Biotechnology, to Canada. The medication was approved by Canada in July for treating Covid-19 patients above 12 years of age with a higher risk of hospitalisation.

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