The first trial failed … The French company announced that the results were positive in the study of the Kovid-19 vaccine.

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Sanofi and GSK’s Kovid-19 vaccine candidate showed strong immune responses in all adult age groups in the phase 2 study in which 722 volunteers participated.

Phase 2 results of the recombinant vaccine candidate Kovid-19, adjuvants from Sanofi and GSK, have been announced.

Accordingly, according to the results of the phase 2 study, in which 722 volunteers participated, strong neutralizing antibody responses were observed in all adult age groups participating in the study, at the levels measured in people who survived Kovid-19 vaccine disease. candidate.

According to phase 2 interim results, the second dose of Sanofi and GSK of the vaccine candidate Kovid-19 was 95% to 100% seroconversion in all age groups (18 to 95 years) after injection, eliminating the safety concerns (Kovid-19 vaccine). the rate of antibody production) was observed.

In line with these results, the global phase 3 study of the vaccine candidate is expected to begin in the coming weeks.

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STUDIES TO SUPPORT VARIANT FORMULATIONS ARE TARGETED

Based on positive interim phase 2 results, the two companies plan to launch a global phase 3 trial, which will include a 10 µg dose of vaccine candidates and the pandemic adjuvant from GSK, with a randomized study method in double blind in the coming weeks.

The phase 3 study is expected to take place with more than 35,000 adult participants from various countries. Phase 3 studies will also assess the efficacy of two vaccine formulations, including Kovid-19 variants D614 (Wuhan) and B.1.351 (South Africa).

In parallel, the companies aim to support various variant formulations to assess the ability of a lower vaccine dose to generate a strong booster response, regardless of the initial vaccine platform.

The vaccine is expected to be approved in the fourth quarter of 2021, in line with the results of the phase 3 studies scheduled to launch in the coming weeks and the license evaluation.

COVID-19 EPIDEMIC CONTROL ACTIVITIES

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In addition to the adjuvanted recombinant protein vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. In March 2021, Sanofi and Translate Bio launched a Phase 1-2 clinical trial for the mRNA vaccine candidate Covid-19 to assess safety, immune response and reactogenicity after preclinical data showed levels high levels of neutralizing antibodies. The first results of this study are expected in the third quarter of 2021.

Sanofi also provides production support to other vaccine manufacturers. The company recently announced that it will produce up to 200 million doses of Moderna’s Kovid-19 vaccine for the United States from September 2021.

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Sanofi also announced earlier this year that it would provide BioNTech with 125 million doses of production support for the European Union. Sanofi also announced in February that Johnson & Johnson would back the company with around 12 million doses per month for the production of the Kovid-19 vaccine.

In addition to developing two candidate Covid-19 vaccine candidates, Sanofi is the only company to leverage its manufacturing capacity and expertise for three different Kovid-19 vaccines to support the global vaccine supply and help combat it. epidemic.

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CAN BE STORED UNDER NORMAL HEAT CONDITIONS

Thomas Triomphe, Executive Vice President and Global President of Sanofi Pasteur, said the following regarding the Phase 2 data:

“We see very clearly that, as new variants of Kovid-19 continue to emerge, the need for effective and immunostimulating booster vaccines to fight the pandemic will continue. Demonstrates that it has the potential to play an important role in public health crisis management.

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With the positive results we have, we are ready to move on to the Phase 3 global efficacy study of our vaccine candidate. We continue to work with our stakeholders around the world to make our vaccine available as quickly as possible. “

The first trial failed ... The French company announced that the results were positive in the study of the Kovid-19 vaccine.

“THE RESULTS HAVE SIGNIFICANT POTENTIAL”

In light of the positive results of the phase 2 study, Roger Connor, head of the vaccine department at GSK, said that the positive responses of the adjuvant protein-based vaccine candidate to the Kovid-19 variants and the booster doses enhancing immunity indicate epidemic control potential.

“We believe that our vaccine candidate can make a significant contribution to the ongoing fight against Kovid-19, and we will move to phase 3 studies as soon as possible to achieve our goal of making it available before the end of the year.” made his assessment.

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