Paris | French laboratory Sanofi will not enter phase 3 trials for its messenger RNA vaccine against COVID, the last step before commercialization, while development of its other vaccine against the virus continues.
Despite interim positive results for phase 1-2 of its messenger RNA vaccine trial, Sanofi believes it would be too late to market, when a total of 12 billion doses of COVID vaccines will have been produced by the end of year.
The results of phase 3 of its other vaccine based on a recombinant protein, developed with the British GSK, are still expected before the end of 2021.
However, initial data from the messenger RNA technology trial are positive: they show seroconversion, that is, the production of antibodies, in 91% to 100% of the participants, two weeks after the second injection, Sanofi said. in a statement issued Tuesday.
These results are valid for all three trials that were tested. Furthermore, no side effects were observed and the safety profile is comparable to that of other COVID-19 RNA vaccines, such as those developed by the German-American tandem Pfizer-BioNTech and by Modern American biotechnology.
With this technology, the laboratory wanted to evaluate the ability to elicit an immune response. “However, this is strong,” Thomas Triomphe, vice president of Sanofi’s vaccine arm, told AFP.
Sanofi had been working with Translate Bio on this vaccine for more than a year and a half, and even bought this American biotech at the beginning of August for about 2.7 billion euros.
However, “the need is not to create new COVID-19 RNA vaccines, but to provide France and Europe with an arsenal of messenger RNA vaccines for the next pandemic, for new pathologies,” adds Thomas Triomphe.
According to data from the International Federation of the Pharmaceutical Industry, by mid-2022, the total production of vaccines against the coronavirus is expected to reach 24 billion doses.
Consequently, Sanofi will not develop phase 3 for this vaccine, because “there is no public health need to have another messenger RNA vaccine,” continues Thomas Triomphe.
Sanofi, on the other hand, says it wants to develop vaccines with this technology against other viruses, without side effects and with fewer restrictions in terms of storage temperature. The group has already launched initial trials of a monovalent vaccine, with a single virus strain, against seasonal influenza. He said Tuesday that he wanted to launch clinical trials against influenza next year, this time with a quadrivalent vaccine.
The laboratory wants to position itself in this technology that, until COVID-19, had not allowed any drug or vaccine to be commercialized. Beyond COVID, messenger RNA is a turning point not to be missed, especially for a traditional vaccine-specialty pharmaceutical group that was left behind during the pandemic.
Sanofi recently stepped up its actions on RNA. In addition to the acquisition of Translate Bio, it announced in June that it would spend at least two billion euros by 2025 on research on new RNA vaccines, investments that should continue beyond this period.
“Our goal is to unleash the potential of messenger RNA in other strategic areas, such as immunology, oncology”, that is, the treatment of cancers, “and rare diseases, in addition to vaccines,” Paul Hudson stressed a few weeks ago. . general manager of Sanofi.
Rapid progress in RNA vaccine development should “allow the pharmaceutical industry to continue to break down barriers, and the oncology market is the most likely market,” according to analyst firm Global Data, to benefit from it. ”