Twist of the scene, really surprising, for Sanofi. The French pharmaceutical giant, born in 2004 from the merger of Sanofi-Synthélabo and Aventis, is abandoning plans for its mRNA-based Covid vaccine, due to the dominant role of the BioNTech-Pfizer and Moderna alliance. Till now, BioNTech and Pfizer have delivered nearly 1.5 billion doses, making it the largest producer of Covid vaccines in the western world.
The decision to abandon the clinical development of an mRNA-based vaccine, obtained through the acquisition of Translate Bio, came for Sanofi despite the positive interim results of the Phase I / II study just announced, in which it is clearly seen how much the response immune system of the Sanofi vaccine is high.
Covid Sanofi vaccine, from low protection to stop
A hard blow for Italy too, given that this vaccine should have been filled in Anagni. In fact, in the province of Frosinone, 70 km from Rome, there is the plant where the doses of the vaccine against Covid-19 directed to the whole European continent should have been passed.
Sanofi had promised Italy 40 million doses by 2021 in October 2020. But immediately great difficulties were evident: already in December 2020, before the start of the vaccination campaign throughout Europe, Sanofi had put his hands on explaining that half of the promised doses, 20 million, would not have arrived in our country by June 2021, as originally expected.
The reason then was due to the results of the preliminary tests on his Covid vaccine, which they had shown a low immune response in adults over 49probably due to an insufficient concentration of antigen. Sanofi had mistaken the amount of the spike protein, which is the antigen that stimulates the response of the immune system, thus triggering an immune response that is too weak.
A laboratory incident revealed last year had delayed its development by at least 6 months, but Sanofi still aimed to bring its vaccine to market by the end of the year, planning to submit clinical data to regulators on its safety and efficacy as a single-dose vaccination and as a booster dose.
Covid Sanofi vaccine, what effectiveness
Initial data from Phase 1/2 showed a neutralizing antibody seroconversion in 91% -100% of study participants 2 weeks after a second injection, in all 3 dosages tested. No safety concerns were observed and the tolerability profile is comparable to that of other Covid mRNA vaccines not modified.
“We are happy to see these initial positive results. We have achieved an impressive result just 9 months after testing the mRNA vaccines and only 17 since we started this first vaccine project, ”said Toussaint.
Why Sanofi blocked his Covid vaccine
But the company, which is developing its vaccine in collaboration with GSK, said reading that data only encouraged it to pursue that technology as a potential basis for a vaccine against influenza and other diseases.
Thus renouncing the Covid area, due to the “strong market presence of the two approved mRNA doses”, namely those of Pfizer and Moderna. All this just as Pfizer continues with its ad hoc experimental drug against the Coronavirus.
Thomas triumph, head of vaccines at Sanofi, said there will be a greater impact on the vaccine market by focusing on applying its proven mRNA technology to other diseases, such as the flu. “There is no public health need now for another Covid-19 messenger RNA vaccine, when you can walk down the street to any pharmacy and get one,” he said. “If we had arrived on the market at the end of 2022 or the beginning of 2023, we would have arrived late and without differentiation”.
Sanofi’s decision shows how mRNA has effectively disrupted the vaccine business that previously seemed untouchable, letting formerly leading companies like Sanofi and Merck rush to catch up. New biotech players, including Moderna and BioNTech, who have partnered with Pfizer, have been able to use the pandemic to demonstrate the effectiveness of their technology.
Sanofi, mRna flu vaccine coming?
“These findings will clearly help map the way forward for our mRNA development programs,” said Jean-Francois Toussaint, global head of research and development at Sanofi Pasteur. Interim results confirmed the platform and support potential of Translate Bio’s recently acquired messenger RNA (mRNA) and lipid nanoparticles (LNP) by Sanofi.
Aiming straight to early 2022 for a modified mRNA flu vaccine, Sanofi launched a Phase 1 clinical trial in June 2021 to evaluate an experimental mRNA-based vaccine against seasonal influenza.
And to say that just a few days ago, in an official statement, Sanofi had stated that it would continue its efforts in the fight against the pandemic with its candidate anti-Covid vaccine developed in collaboration with GSK. But in parallel it had already expanded its development program to include a vaccine study to address any new public health needs.
Recently published preclinical data indicated that Sanofi’s vaccine candidate has the potential to strongly increase immune responses after primary vaccination across multiple vaccine technology platforms and against a broad spectrum of variants of concern.
Studies began this summer in the United States, Australia, France and the United Kingdom. The first results are expected by the end of 2021.
Because Sanofi risks losing the race
To date, Sanofi has supplied half a billion doses of licensed vaccines and is thethe only company that exploits its production capacity and worldwide expertise for the supply of the three different authorized Covid vaccines, those of Pfizer, Moderna and Johnson & Johnson, using production teams at the company’s three industrial sites in France, Germany and the United States.
Sanofi also recorded 2.5 billion euros in sales of flu vaccines in 2020, never before in its history, reaching a total turnover of 5.9 billion euros. But even here, as for Covid, it remains to already be left behind.
Pfizer announced a few days ago that it is starting human trials for its mRNA flu vaccine, while Moderna began similar tests in the United States in July. The established provider of influenza vaccines Seqirus, part of the Australian CSL is working on next-generation low-dose RNA flu vaccines, known as self-amplifying RNA. Other companies including Novavax they are working on new flu vaccines using new technology beyond mRNA.