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Sanofi will produce in France the vaccine against the covid-19 of its American competitor Johnson & Johnson, as it is also preparing to do for Pfizer-BioNTech, failing to be able to offer at this stage its own vaccine for which it has launched a new clinical trial Monday.

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“Sanofi will support several stages of manufacturing the Johnson & Johnson covid-19 vaccine from the third quarter of 2021”, the time to acquire, install and qualify its facilities for the viral vector vaccine of the American competitor, announced the French laboratory in a press release. He will take care of the formulation and filling of the vials at its Marcy-l’Etoile site, near Lyon, “In 2021, at a rate of approximately 12 million doses per month”. “Our ambition is to do as much as possible, if we can do more why not,” Thomas Triomphe, executive vice-president of Sanofi Pasteur, the group’s vaccines branch, told AFP.

All the preparatory work had started a lot upstream with a view to producing a Sanofi vaccine and today, this work is not lost.

An announcement welcomed by the President of the French Republic: “We must together accelerate the production of vaccines through industrial partnerships. While continuing its research, Sanofi will take charge of several stages in the manufacture of Johnson & Johnson’s vaccine to respond quickly to European and global demand, ”Emmanuel Macron reacted on Twitter.

“We had worked actively for the production of vaccines on this site” of Marcy-l’Etoile, welcomed Pascal Lopez, FO central union representative at Sanofi. “All the preparatory work had started a lot upstream with a view to producing a Sanofi vaccine and today, this work is not lost, that’s what is gratifying. “

Sanofi will also work with Pfizer-BioNTech

Sanofi had already agreed to manufacture from the summer, in its German factory in Frankfurt, more than 125 million doses of messenger RNA vaccine developed by Pfizer-BioNTech. The urgency of the pandemic has given rise to unexpected alliances between companies in the sector. The Swiss Novartis, which is not launched in the vaccine race, is also preparing to produce for BioNTech. For the CEO of Sanofi, Paul Hudson, this agreement with Johnson & Johnson “demonstrates Sanofi’s determination to contribute to the collective effort to end this health crisis as quickly as possible” and to show “solidarity” .

These nudges come after the French government asked Sanofi to make its production lines available to speed up the availability of doses, eagerly awaited in an attempt to curb a pandemic that has killed nearly 2.5 million people in the world. “Our top priority remains the manufacture of our own vaccine. If we do this operation with BioNTech or Johnson & Johnson, it is because we have made sure that we also have the capacity to produce our own vaccine, ”insisted Thomas Triomphe.

(AFP)

Because if it has suffered setbacks, the French laboratory is determined to succeed. He also announced on Monday that he was starting a new so-called “phase 2” clinical study of its main vaccine candidate developed with the British GSK and using recombinant protein technology, hoping to make it available in the fourth quarter. It was initially planned for the summer of 2021. “This new phase 2 study will assess the potential of a refined formulation of antigens in order to obtain an optimal immune response, particularly in older adults,” explains- he does.

Research on new variants

The previous phase 1/2 study concluded in December of an insufficient immune response in older adults, “probably due to an insufficient concentration of antigens”. The new trial will be conducted on 720 volunteers over the age of 18 in the United States, Honduras and Panama. If the data are positive, a phase 3 study, the last step before applying for a marketing authorization, should begin “in May-June” in a “large number of countries on several continents”, according to Mr. Triumph.

According to him, Sanofi has also started research on new variants and “to be able to prepare different formulations to go as quickly as possible when needed.” The laboratory is also developing a second vaccine candidate with the American company Translate Bio, based on the more recent messenger RNA technology (used by vaccines already authorized by Pfizer / BioNTech and Moderna). “Preclinical data has shown that two injections of the mRNA vaccine induce the production of a high concentration of neutralizing antibodies”, according to Sanofi, which intends to start testing the vaccine on human volunteers, in a phase 1/2, in March.

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