The Phase 2 results of the recombinant Kovid-19 vaccine candidate, adjuvants of 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 the measured rates of the vaccine candidate surviving the Kovid-19 disease in all adult age groups participating in the study.
According to the Phase 2 interim results, Sanofi and GSK’s second dose of the Kovid-19 vaccine candidate was seroconversion from 95 percent to 100 percent in all age groups (18 to 95 years) after injection, eliminating safety concerns (Kovid-19 vaccine). the rate of producing antibodies) was observed.
In line with these results, the global Phase 3 study of the vaccine candidate is expected to begin in the coming weeks.
Studies to support variant formulations are aimed
Based on positive Phase 2 interim results, the two companies plan to launch a global Phase 3 trial, which will include 10µg dose of vaccine candidates and GSK’s pandemic adjuvant, in a randomized, double-blind study method in the coming weeks.
The Phase 3 study is planned to take place with more than 35 thousand adult participants from various countries. Phase 3 studies will also evaluate the effectiveness of two vaccine formulations, including D614 (Wuhan) and B.1.351 (South Africa) variants of Kovid-19.
In parallel, companies aim to support various variant formulations to evaluate the ability of a lower vaccine dose to generate a strong booster response, independent 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 planned to be launched in the coming weeks and the evaluation of the license.
Studies in the fight against the Kovid-19 epidemic
In addition to recombinant protein-based vaccine with adjuvants 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 Covid-19 vaccine candidate to assess safety, immune response and reactogenicity after preclinical data showed high levels of neutralizing antibodies. The first results of this study are expected in the third quarter of 2021.
In addition to developing two 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 the epidemic.
Can be stored under normal temperature conditions
Thomas Triomphe, Executive Vice President and Global President of Sanofi Pasteur, said the following regarding Phase 2 data:
“We see very clearly that as new variants of Kovid-19 continue to emerge, the need for effective and immune-boosting booster vaccines in combating the pandemic will continue. demonstrates that it has the potential to play an important role in managing the public health crisis.
With the positive results we have, we are ready to move on to the global Phase 3 efficacy study of our vaccine candidate. We continue to work with our stakeholders around the world to make our vaccine available as soon as possible. “
“The results point to an important potential”
In the light of the positive results of the Phase 2 study, Roger Connor, Head of GSK Vaccines Department, stated that the positive responses of the protein-based adjuvant vaccine candidate to Kovid-19 variants and the immune-enhancing booster doses indicate an important potential in the fight against the epidemic.
“We believe that our vaccine candidate can make a significant contribution to the ongoing fight against Kovid-19, and we will move on to Phase 3 studies as soon as possible to achieve our goal of making it available before the end of the year.” made its evaluation.