(RTTNews) - Sanofi (SNYNF, SNY) and GlaxoSmithKline Plc. (GSK.L, GSK) said that they have signed agreements with the Government of Canada to supply up to 72 million doses of their potential COVID-19 vaccine, beginning in 2021.
The companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year.
If the data are sufficient for licensure application, the companies plan to request regulatory approval in the first half of 2021. Meanwhile, they are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.
On September 18, Sanofi and GSK signed a final agreement with the European Commission to supply European countries with up to 300 million doses from their European industrial network.
In July 2020, Sanofi and GSK announced a collaborative effort with the U.S. government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine. The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term.
The companies also agreed with the UK government to supply up to 60 million doses of recombinant protein-based COVID-19 vaccine.
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