After months of delay, the Sanofi group’s Covid-19 vaccine has now reached a decisive stage. The French pharmaceutical group announced, Thursday, May 27, the launch of large-scale trials for its main vaccine project against Covid-19, developed with the British GSK, confirming that it hopes for a launch at the end of 2021 for this product.
“Sanofi and GSK are launching an international phase 3 study to assess the efficacy of their vaccine against [le] Covid-19 “, the French group said in a statement, ten days after the announcement of encouraging results after initial tests. The latter, called “phase 2” and carried out on a few hundred people, had shown that this vaccine causes the production of antibodies against the coronavirus in most of the subjects to whom it has been injected.
But it is the tests announced this Thursday that should give a real idea of the effectiveness against Covid-19 of this serum, for which GSK provides the adjuvant. They will be carried out with some 35,000 people in multiple countries, including the United States.
If the results are favorable, Sanofi, which is already preparing the production of this vaccine, counts on an approval in the fourth quarter by the main health authorities.
Launch one year after the first vaccines
This means that, in the best-case scenario, Sanofi’s vaccine will be launched almost a year after the first products distributed in the Western world against the coronavirus, those from Pfizer-BioNTech and Moderna. In the European Union (EU), those of Johnson & Johnson and AstraZeneca have already been on the market for weeks. More broadly, in the world, the Russian Sputnik V and Chinese Sinovac vaccines also play an important role in vaccination campaigns.
This late arrival is explained by malfunctions in the development of the vaccine by Sanofi, which suffered a setback of several months. Launched in the vaccine race at the start of the pandemic, the latter suffered a setback in December 2020, which had resulted in a delay in its development. The preliminary results of its phase 1 and 2 clinical trials, launched in September, had not then demonstrated a satisfactory immune response in the elderly, the populations most at risk from the coronavirus. “The results of the study are not up to our expectations”, conceded Roger Connor, president of GSK Vaccines, in December 2020. Sanofi attributes these disappointing results to an insufficient concentration of antigen in its product, which has since been corrected.
A vaccine that will find its place, assures the group
The group continues to ensure that its serum will find its place all the same. As such, it will both assess whether this vaccine is effective against the so-called “South African” variant, one of the main new strains of the virus, and whether it is used as a booster after another vaccine.
This is a recombinant protein vaccine, a technology different from vaccines already approved: to produce an immune response, it plans to inject not an attenuated or inactivated virus, as in traditional vaccines, but a piece of the virus. , the envelope protein. This technology is already used in particular against hepatitis B and pertussis.
Sanofi is also developing another messenger RNA vaccine like those from Pfizer and Moderna, but is still at an early stage.