Le géant pharmaceutique français Sanofi et le britannique GSK ont annoncé lundi des résultats positifs dans les essais cliniques de leur vaccin Covid-19 après un revers précédent, laissant espérer qu'il pourrait être ajouté à l'arsenal mondial de vaccins. </p><div> <p>Les entreprises ont déclaré que les résultats de l'étude de phase 2 leur permettraient de passer à un essai de stade avancé dans les semaines à venir - un renversement de fortune après les résultats décevants des recherches précédentes de l'année dernière.
The experimental vaccine “achieved high rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19,” Sanofi and GSK said in a statement.
The trials were carried out on 722 adult volunteers.
An earlier study in late 2020 showed the vaccine provided a weak immune response in the elderly. The companies said at the time that the vaccine would not be ready until the end of 2021.
The initial failure was a setback that marred French pride, with France being the only permanent member of the UN Security Council not to have its own vaccine after the successes of Britain, China, from Russia and the United States.
“Our Phase 2 data confirms the potential of this vaccine to play a role in addressing this ongoing global public health crisis,” said Thomas Triomphe, executive vice president and global director of Sanofi Pasteur.
“As we know, more vaccines will be needed, especially as variants continue to appear and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” he said. declared.
The final phase 3 trial will be conducted among 35,000 adults “in a wide range of countries,” the companies said. It should start in late May or early June.
It will test the effectiveness of the vaccine against the strain first found in Wuhan, China, in late 2019 and the variant detected in South Africa. The previous candidate was only tested against the variant found in Wuhan.
The companies expect to gain regulatory approval in the last three months of 2021 – one year after the vaccines from Pfizer-BioNTech and Moderna.
Approval end of 2021
The companies are combining an antigen developed by Sanofi, which stimulates the production of germ-killing antibodies, with adjuvant technology from GSK, a substance that enhances the immune response triggered by a vaccine.
The phase 2 trial shows that after a second dose, the vaccine produced a “strong immune response” in adults of all age groups, with rates of seroconversion – or antibody production – varying between 95 and 100 percent, according to Sanofi and GSK. .
The volunteers were between 18 and 95 years old.
Research also showed that one dose produced high levels of antibodies in people who had previously been infected with the coronavirus, which would make the vaccine useful as a booster shot.
Jabs from the British pharmaceutical company AstraZeneca and the American company Johnson & Johnson have also been deployed in Europe.
Sanofi is in talks to deliver doses to the United States, Canada and the European Union, France Sanofi president Olivier Bogillot told Europe 1 radio.
“Most countries were waiting for the results of phase 2 to be able to place orders,” Bogillot said.
Sanofi is developing a second vaccine with the American company Translate Bio, using the same messenger RNA technology as Pfizer-BioNTech and Moderna.