Sanofi, the French drug hero, is not going away. The dossier on a phase 3 clinical trial of its anti-viral vaccine was submitted at the end of February to the European Medicines Agency (EMA), more than a year after its competitors Pfizer-BioNTech and Moderna. The European Authority has been working on it since July 2021, based on preliminary data, and could issue its opinion soon, possibly before the fall and a possible new wave of Covid-19. French health authorities are by no means optimistic: “The results announced by the laboratory look good, but we are still waiting for the results of the evaluation conducted by the EMA,” notes the Telegram spokesperson for the Directorate General of Health (DGS).
A “strategic” vaccine for France
If there is a green light, how many bottles can be allocated to France as part of the purchase made at the European level? So far, France has ordered 19.9 million doses of the Sanofi vaccine. This order was confirmed in October 2020,” DGS told us. For comparison, the country received roughly the same volume of vaccines in March (mainly from Pfizer-BioNTech) and 13 million in April, according to Le Parisien figures, while vaccines have now fallen to low levels, with a total of two million injections. conducted within the past two months. 3.6 million doses of AstraZeneca, which expires this month, will also have to be disposed of, according to our Paris colleagues.
How do you justify, then, this volume of orders for a Sanofi product? “It is based on a proven technology (a recombinant protein vaccine with or without adjuvants) (…). This modified vaccine is strategic in that it is more powerful and effective in the face of new variables, as confirms the General Directorate of Health, without being able to support its statements with scientific studies. “This new vaccine will therefore allow us to effectively complement our vaccine portfolio in the vaccination strategy,” concludes DGS, which is seeking to build up a permanent stockpile of 50 million doses.
It was confirmed that the Sanofi vaccine would be intended initially for the initial vaccination of adults and, depending on the permissions and opinions of the scientific authorities, to obtain booster doses under heterogeneous systems, ie to mix two types of vaccination, RNA and then recombinant protein, for example.
So far, the Sanofi vaccine doses requested by France are not sent to less affluent countries, via the Covax system. “This may change in the coming months depending on states’ needs and future arbitrations,” the DGS specifies. However, a donation agreement is under discussion between the French laboratory and the European Commission.
Important Marketing Authorization for Sanofi
Therefore, Sanofi is interested in obtaining a marketing license for its vaccine to fulfill its contracts. Notably because, as released to Mediapart by the Ministry’s delegate to industry, at the beginning of 2021, “Abandonment of the company, such as not obtaining a marketing license, results in early termination of the contract, with similar consequences: We are not tied to any future payments, and for For a deposit already paid, this results either in reimbursement (partially or in full, as the case may be) of the paid deposit (…). In response to a request for us to confirm the existence of this clause, the Ministry of Industry referred us to the Ministry of Health, which states that “these contractual elements are confidential and cannot be reported.”
Reuters indicated, in September 2020, that the European Union paid a deposit of 324 million euros to Sanofi. Call, the French lab does not confirm. His answer: “We are producing the quantities needed to meet the demand in the existing pre-purchase agreements. We will implement in accordance with our commitments and according to the needs of the health authorities. We have said, from the beginning, that our participation in the fight against the Corona virus is not linked to financial gain.”