Agnès Pannier-Runacher had sold the wick last Wednesday at the microphone of France Inter: "Sanofi will publish the results of clinical trials around May 17". In charge of Industry, the Minister was well informed. This Monday morning, the French laboratory effectively published the conclusions of clinical trials carried out for several months on 722 volunteers over 18 years of age in the United States, Honduras and Panama, concerning its recombinant protein vaccine candidate against Covid- 19, developed with the British GSK. "I wish for this recombinant protein vaccine to have good results because it can be a very interesting solution," the minister also added. It is a vaccine on which we have decades of data on how it works. "
It appears to be the case. "These results induced the production of high concentrations of neutralizing antibodies in adults after administration of a single dose," explained Thomas Triomphe, executive vice president of Sanofi and head of vaccines, at a conference. hurry. And this all age groups combined, at levels comparable to those observed in people who had recovered from an infection. "
The efficacy rate, greater than 90% for competing vaccines already on the market, will not be known with precision until after phase 3, which corresponds to tests on thousands of volunteers this time.
"But the immune response rate, that is to say the positive reaction to the vaccine, with production of antibodies in the body, is already excellent," said Dr Su-Peing Ng, head of medical affairs. vaccines.
Between 95 and 100% of people tested have thus produced antibodies against the virus in their body after the injection of the vaccine.
Sanofi must catch up
The challenge for Sanofi is immense. The French laboratory must absolutely try to catch up in the vaccine race against Covid-19. While it continues to conduct clinical trials, four vaccines are already on the market in Europe: Pfizer, Moderna, AstraZeneca and Janssen. That of the German Curevac should be distributed this month. In the spring of 2020, when the pandemic had already spread to the four corners of the globe, Sanofi was nevertheless carrying out a clinical trial combining both phase 1 and 2 on this famous candidate vaccine with recombinant protein. The laboratory was already very familiar with this technology to use it on its influenza vaccine, authorized since 2017 in the United States.
But in the rush, the teams had incorrectly dosed the antigen concentration in the serum.
Result: the immune response against the coronavirus of the selected volunteers was insufficient, especially in adults over 50 years old.
"The reagents (
Editor's note: control, for antigen measurements
) used were not of sufficient quality or purity", then explained Thomas Triomphe to the Wall Street Journal.
Everything had to be redone.
Tested against the South African variant
After long months of delay, it is therefore the results of a new phase 2, relating to the same vaccine candidate, which were unveiled on Monday. "Thanks to these results, we will be able to launch phase 3 on more than 35,000 volunteers in the coming weeks, in a large number of countries and several continents," added Thomas Triomphe. It will focus on the vaccine as such, as a first injection, but also on its effectiveness against different variants, especially South African, and as a booster, in the second or even third injection, regardless of the technologies used. for previous injections. If all goes well, the vaccine is scheduled for marketing in the fourth quarter.
In the meantime, Sanofi has gone to work for its main competitors, willy-nilly donning the costume of super-subcontractor. From this summer, it will manufacture in its German factory in Frankfurt more than 125 million doses of the messenger RNA (mRNA) vaccine developed by Pfizer-BioNTech. From September onwards, the formulation and filling of Janssen bottles will be carried out at the Marcy-l'Étoile site, in the suburbs of Lyon (Rhône). Expected rate: 12 million doses per month. It also announced another partnership, with Moderna this time around, to produce up to 200 million doses of the vaccine at its Ridgefield (New Jersey) site in the United States, also starting next September.
In parallel, Sanofi is also conducting phase 1 clinical trials on a second candidate vaccine, this time using mRNA, with the American company Translate Bio. Based on newer messenger RNA technology. Its management had also confirmed to us that it had also started research on new variants. Objective: "Prepare different formulations in advance, in order to draw as quickly as possible the day when a more suitable vaccine has to be released".