Sanofi and GSK are finally approaching the end of the tunnel. On Thursday, the French pharmaceutical group announced the start of phase 3 clinical trials for its anti-Covid-19 vaccine project, developed with its British partner, confirming to expect a launch at the end of 2021 – if the authorities validate its marketing. A breakthrough that comes ten days after the announcement of encouraging results at the end of phase 2 of the trials.
The latter, 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 which it has been injected. But it is the trials announced Thursday that should give a real idea of the effectiveness against Covid-19 of this vaccine, for which GSK provides the adjuvant. They will be carried out with more than 35,000 people in multiple countries, including the United States.
Tests for the South African variant
The study will be conducted in two parts. The first will aim to assess the immune reaction to the classic strain of Covid-19. The second will focus on the so-called South African variant. “Recent scientific evidence has shown that the antibodies generated against the B.1.351 variant could indeed confer extensive cross-protection against other more transmissible variants,” says Sanofi.
The serum works on the principle of the recombinant protein, a technology different from the vaccines already approved. Sanofi is also developing another messenger RNA vaccine like those from Pfizer and Moderna, but this is still at an early stage.
One year behind on the first vaccines
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. This means that, in the best-case scenario, Sanofi’s vaccine will be launched almost a year after the first vaccines distributed in the Western world against the coronavirus, those from Pfizer / BioNTech and Moderna.
This late arrival is explained by malfunctions in the development of the vaccine, which caused a setback of several months. Since then, Sanofi and GSK have continued to ensure that its product will still find its place. “We believe that other solutions are needed to fight COVID-19 and succeed in protecting the greatest number of people, everywhere in the world – especially as the pandemic continues to evolve and that variants of the viruses keep emerging, ”said Roger Connor, president of GSK Vaccines in the statement.