Dive Brief:
- Sanofi on Tuesday said the messenger RNA-based coronavirus vaccine it is developing sparked immune responses in an early-stage trial. But the French pharma will not advance testing further and instead focus on a protein-based shot it's working on with GlaxoSmithKline. Sanofi said it still plans on using mRNA technology, but in an influenza vaccine, with clinical testing targeted to begin in 2022.
- In a statement, the French drugmaker said mRNA-based coronavirus vaccines from Pfizer and Moderna are widely available, making a third one unnecessary. Its protein-based shot, meanwhile, is being evaluated as a primary immunization in late-stage trials, and will also be developed as a booster to other types of vaccines.
- Sanofi acquired the mRNA technology with its $3.2 billion buyout of partner Translate Bio, part of a big bet the company is making on the space. In shifting its focus to an influenza vaccine, Sanofi will also switch from the unmodified mRNA that it used in the coronavirus vaccine to a modified type, which may amplify the immune response.
Dive Insight:
When drugmakers geared up to respond to the pandemic, Sanofi and GSK, as two of the largest vaccine makers, were expected to make a major contribution. Protein-based vaccines, which use a synthetic version of the coronavirus' "spike" protein to stimulate an immune response, are an older, more familiar technology than mRNA. The manufacturing and distribution infrastructure for them are also well-established.
Yet the first version of the Sanofi-GSK vaccine didn't live up to expectations, forcing the companies to turn to a second formulation that they advanced into a late-stage study of more than 37,000 volunteers. With more than half the world's population yet to be fully vaccinated, and the likelihood booster shots will be needed, their vaccine could yet play an important role.
Parallel to its work in protein vaccines, Sanofi had added a coronavirus project to its long-standing mRNA vaccine partnership with Translate Bio. The company then expanded its overall investment in mRNA by launching a research "center of excellence." Those moves culminated in an acquisition of Translate in August.
The vaccine from the mRNA partnership did raise antibodies against the coronavirus. Three weeks after the second of two doses, antibody levels had increased at least fourfold from baseline in nearly all of the patients tested, and the shot had the same safety and tolerability profile as other mRNA vaccines, Sanofi said.
Nonetheless, the wide availability of mRNA vaccines from Pfizer and Moderna, a spokesperson said, mean "it does not make sense" to advance that product.
Sanofi sees more promise for mRNA in fighting influenza. The company has already conducted Phase 1 trials of two formulations targeting a single strain, A/H3N2, and is hoping to expand that work in 2022.
Sanofi won't be alone in that quest. Moderna began Phase 1 work in July and Pfizer started its first tests Monday.
Of the three companies, only Sanofi is an established name in flu vaccines, with its shots bringing in 2.5 billion euros, or about $2.9 billion, in 2020. Pfizer has a vaccines business too, and its pneumococcal vaccine franchise Prevnar is one of the largest-selling pharmaceutical products in the world.