22nd Feb 2021 11:17
(Alliance News) - Sanofi SA and GlaxoSmithKline PLC initiated a new phase 2 study with 720 volunteers to select the most appropriate antigen dosage for phase 3 evaluation of their adjuvanted recombinant protein Covid-19 vaccine candidate, both companies said on Monday.
In parallel to the new phase 2 study and recognising the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants which will be used to inform the next stages of the Sanofi/GSK development programme.
"Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial phase 1/2 study," said Thomas Triomphe, executive vice president & head of Sanofi Pasteur.
"We look forward to further progressing this vaccine candidate to phase 3 in the second quarter of 2021, if this phase 2 study is successful," added Roger Connor, president of GSK Vaccines.
Sanofi shares were trading 0.3% lower in Paris on Monday at EUR76.82 each, while GSK shares were up 0.7% in London at 1,223.10 pence each.
Also on Monday, Sanofi said it has agreed with Janssen Pharmaceutical NV and Janssen Pharmaceuticals Inc, two Johnson & Johnson subsidiaries, to support manufacturing of Janssen's Covid-19 vaccine.
Janssen has submitted an application to the US Food & Drug Administration requesting emergency use authorization for its single-dose Janssen Covid-19 vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency.
Once authorized, Sanofi said it will provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l'Etoile, France, to formulate and fill vials of Janssen's Covid-19 vaccine candidate in 2021, at a rate of 12 million doses per month.
Johnson & Johnson shares closed 1.7% lower in New York on Friday at USD162.98 each and lost a further 0.9% in the pre-market trading on Monday.
By Evelina Grecenko; [email protected]
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