Sanofi Abandons mRNA COVID-19 Vaccine Development Despite Positive Early Results, Citing Missed Market Window

Compiled by | Fan Dongdong

Despite positive results from early-stage trials, Sanofi recently announced it will discontinue development of its mRNA-based COVID-19 vaccine. The company believes it is too late to launch a similar product now that competitors such as BioNTech, Pfizer, and Moderna have already captured the market.

In August this year, Sanofi acquired Translate Bio for up to $3.2 billion, aiming to secure greater market opportunities in the rapidly developing mRNA COVID-19 vaccine sector by acquiring a new platform. However, following an analysis of the Phase 1/2 interim data and a decision to accelerate its transition to improved mRNA technology, the company ultimately discontinued the development of this type of mRNA COVID-19 vaccine.

The mid-stage trial of the vaccine yielded positive results. Sanofi reported that two weeks after administration of the second dose, neutralizing antibody levels increased four-fold or more from baseline in 91% to 100% of subjects across the three different dose cohorts. Sanofi stated that no safety concerns were identified for the COVID-19 vaccine during the trial, and its tolerability profile was consistent with that of other unmodified mRNA vaccines. However, following analysis, the company concluded that competitors such as BioNTech, Pfizer, and Moderna have maintained a leading position in this market segment for an extended period. Under these circumstances, launching its independently developed mRNA vaccine into an already crowded market would hold no commercial value.

A laboratory incident in 2020 delayed Sanofi’s COVID-19 vaccine development progress by at least six months. In response to inquiries from the Associated Press, the company stated that from a public health perspective, mRNA COVID-19 vaccines are now widely used, making placebo-controlled trials highly challenging in countries where COVID-19 vaccines have already been administered. Consequently, Sanofi has determined that further development of its mRNA COVID-19 vaccine is no longer justified. Thomas Triomphe, Head of Sanofi Vaccines, noted that the pharmaceutical company has decided to focus on applying its now-proven mRNA technology to other diseases, such as influenza.

Pfizer, BioNTech, and Moderna have all modified the mRNA in their COVID-19 vaccine products in an attempt to prevent patients from mounting an inflammatory response against foreign nucleic acids. In contrast, the COVID-19 vaccine developed by CureVac employs unmodified mRNA technology, relying instead on alterations to the vaccine’s own RNA sequence to evade detection by the patient’s immune system.

However, the tremendous success of the Pfizer, BioNTech, and Moderna vaccines stands in stark contrast to the clinical data from CureVac's vaccine. While mutations in circulating viral strains may partially explain the varying efficacy trial results across different vaccines, researchers still consider mRNA modification crucial to the success of this type of vaccine. Indications suggest that Sanofi is also poised to join the ranks of developers utilizing modified mRNA technology. In the statement disclosing Phase 1/2 data for the vaccine, Sanofi stated that it is “accelerating the conversion of its acquired platform technology into modified mRNA.”

Additionally, Sanofi stated that it will continue to utilize a more traditional manufacturing technology from GlaxoSmithKline to develop another COVID-19 vaccine, which employs recombinant protein molecules to deliver antigens. Amid the impact of the COVID-19 pandemic, established vaccine manufacturers like Sanofi face the challenge of safeguarding their existing businesses from further disruption. The focus of the next competitive battle appears to be shifting toward influenza. Sanofi’s vaccine revenue last year neared €6 billion, with €2.5 billion coming from influenza vaccines.

Sanofi stated that the company aims to begin human clinical trials of an mRNA-based influenza vaccine next year.

Sanofi and Translate Bio became among the first companies to initiate trials of seasonal mRNA influenza candidate vaccines in June, but the current R&D focus has shifted to improved quadrivalent mRNA influenza vaccines.

However, Sanofi appears to once again face the risk of falling behind. Notably, Pfizer also initiated a Phase I clinical trial for a quadrivalent influenza mRNA vaccine this week. Meanwhile, Moderna had already commenced a similar trial in the United States as early as July of this year.

Reference Source:

1.After $3.2B deal, Sanofi dumps Translate's mRNA COVID vaccine but hits the gas on switch to modified molecules

2.Sanofi drops plans for mRNA virus vaccine

3.Sanofi stops development of Covid vaccine based on mRNA technology