News – EN – Sanofi launches phase II study of their COVID-19 vaccine with GSK

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the 22nd022021 at 11:56 am

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PARIS (Reuters) – Sanofi and its British partner GSK announced the launch of the new phase II study on their COVID-19 vaccine on Monday after an initial study that gave insufficient results in older people

“In recent weeks, our teams have been working to refine the formulation of antigens for our recombinant protein vaccine, based on lessons learned from our initial phase I / II study,” said Thomas Triomphe, vice -Executive Chairman and Head of Sanofi Pasteur

“We are confident in the strong potential of our vaccine candidate and the latest preclinical data we have obtained is very encouraging,” he added in a statement.

In December, Sanofi announced that the interim results of the phase I / II study of the vaccine candidate developed with GSK had shown an “insufficient” immune response in the elderly, probably due to insufficient concentration of ‘antigens

This forced the group to launch a new clinical study and caused a delay in the development program

On Monday, the group confirmed that if the results of the phase II study prove positive, the phase III trial is expected to begin in the second quarter of 2021 Vaccine availability is still expected in Q4 2021

The vaccine candidate developed by Sanofi and GSK is based on the technology used by Sanofi against seasonal influenza It is associated with an adjuvant, a product intended to stimulate its action, developed by GSK

The new phase II study will be conducted in adults 18 years of age and older to assess the safety, reactogenicity and immunogenicity of two injections given 21 days apart

Three different doses of antigens combined with a fixed dose of adjuvant will be tested in a total population of 720 volunteers, recruited from the United States, Honduras and Panama, Sanofi said.

The group has also announced that it has started research on new variants of the virus that have emerged in the world, the results of which it will integrate in the next stages of the development program of its vaccine developed with GSK

Sanofi is working on another vaccine candidate with the American Translate Bio using messenger RNA technology Phase I / II trials of this vaccine to begin in the first trimester

Faced with the lead taken by its competitors, which are facing production difficulties, Sanofi has agreed to help Pfizer-BioNTech produce and distribute more than 125 million doses of the vaccine against COVID-19

He signed a similar agreement with Johnson & Johnson to help the US pharmaceutical company produce its vaccine

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Vaccine, Johnson & Johnson, GlaxoSmithKline, Sanofi Pasteur

News – EN – Sanofi launches with GSK the phase II study of their vaccine against COVID-19
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Source: https://www.challenges.fr/top-news/sanofi-lance-avec-gsk-l-etude-de-phase-ii-de-leur-vaccin-contre-le-covid-19_752222