Coronavirus company news summary – the EC joins the COVAX Facility – Canada signs vaccine supply deals with Novavax and Janssen

1 September 2020 (Last Updated September 1st, 2020 09:36)

1 September 2020 

GlaxoSmithKline (GSK) and Vir Biotechnology have started dosing participants in a Phase II/III clinical trial of VIR-7831 (GSK4182136) as a potential early treatment for Covid-19 patients at high hospitalisation risk. VIR-7831 is a fully human anti-SARS-CoV-2 monoclonal antibody developed to bind to an epitope present on the virus. The Phase II/III trial will evaluate the ability of the drug candidate to prevent Covid-19-related hospitalisation in about 1,300 patients with early symptomatic infection globally.

The Government of Canada has entered into an agreement in principle with Novavax for the supply of up to 76 million doses of Covid-19 vaccines. An advance purchase agreement is expected to be finalised so Novavax can begin supplying to Canada in the second quarter of next year. In addition, the country has signed a similar agreement with Johnson & Johnson for up to 38 million doses of Janssen’s potential Covid-19 vaccine.

AstraZeneca has advanced its Covid-19 vaccine candidate, developed by the University of Oxford, into a Phase III clinical trial in the US. The trial will evaluate the safety, efficacy and immunogenicity of the vaccine to prevent Covid-19 in up to 30,000 adults aged 18 years or above. Late-stage trials of the product are ongoing in the UK, Brazil and South Africa, with studies planned to begin in Japan and Russia.

The European Commission (EC) is set to participate in the international COVAX Facility initiative, which aims to speed-up the development and manufacture, as well as ensure equitable access to, affordable Covid-19 vaccines. To support the initiative, the EC committed to provide €400m in guarantees. Detailed terms for the European Union's participation and contribution are yet to be finalised.

Sanofi has reported that the global Phase III clinical trial of Kevzara (sarilumab) has missed its primary endpoint and key secondary endpoint in severely or critically ill hospitalised patients with Covid-19, when compared to placebo. Data showed numerical trends toward reduction in duration of hospital stay and an accelerated time to clinical outcomes improvement but these trends were not statistically significant. The study was performed in 420 patients across Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain.

The Japanese Agency for Medical Research and Development has selected Daiichi Sankyo’s mRNA-based Covid-19 vaccine candidate for inclusion in a drug discovery programme. The company plans to launch human trials of the vaccine around March next year, in partnership with the University of Tokyo’s Institute of Medical Science.