Sanofi, GSK In Talks To Supply EU With Up To 300 Mln COVID-19 Vaccine Doses

(RTTNews) - Drug makers Sanofi (SNYNF, SNY) and GlaxoSmithKline plc (GSK.L, GSK) announced Monday that they are in advanced discussions with the European Commission for the supply of up to 300 million doses of a COVID-19 vaccine.

The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established pandemic adjuvant technology.

The companies said the doses for EU would be manufactured in European countries including France, Belgium, Germany and Italy.

Sanofi, which leads the clinical development and registration of the COVID-19 vaccine, expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020.

If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.

GSK and Sanofi have been already selected by U.S. government's Operation Warp Speed to supply with 100 million doses of COVID-19 recombinant protein-based vaccine.

The companies also signed agreement with the United States where they have a longstanding partnership with the Biomedical Advanced Research and Development Authority.