Sanofi, the French drug champion, does not let go. The dossier relating to the phase 3 clinical trial of its anti-covid 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, probably before the fall and a possible new wave of covid-19. The French health authorities seem in any case optimistic: « The results announced by the laboratory seem good but we are still waiting for those of the evaluation conducted by the EMA », indicates to the Telegram a spokesperson for the Directorate General of the health (DGS).
A “strategic” vaccine for France
If there is a green light, how many bottles could be assigned to France, as part of the purchasing process carried out at European level? “To date, France has ordered 19.9 million doses of the Sanofi vaccine. This order was confirmed in October 2020”, we are told by the DGS. For comparison, the country received around the same volume of vaccines in March (mainly from Pfizer-BioNTech) and 13 million in April, figures the newspaper Le Parisien, while vaccinations have now fallen to low levels, a total of two million injections having been performed over the past two months. 3.6 million AstraZeneca doses, which will expire this month, will also have to be thrown away, reveal our Parisian colleagues.
How to justify, then, such a volume of orders for the Sanofi product? “It is based on proven technology (recombinant protein vaccine administered with or without adjuvants) (…). This adapted vaccine is strategic insofar as it is more powerful and effective in the face of new variants ”, assures the General Directorate of Health, without however being able to support its statements with scientific studies. “This new vaccine will therefore allow us to effectively complete our portfolio of vaccines in the vaccination strategy,” concludes the DGS, which is seeking to build up a permanent stock of 50 million doses.
It is confirmed that the Sanofi vaccine will initially be oriented for adult primary vaccination and, depending on the authorizations and opinions of the scientific authorities, for booster shots within the framework of heterologous regimens, i.e. to mix two types of vaccination, RNA then recombinant protein, for example.
To date, the doses of Sanofi vaccine ordered by France are not sent to less wealthy countries, via the Covax system. « This may change in the coming months depending on the needs of the States and future arbitrations », specifies the DGS. A donation agreement is nevertheless under discussion between the French laboratory and the European Commission.
A crucial marketing authorization for Sanofi
Sanofi therefore has every interest in obtaining marketing authorization for its vaccine to honor its contracts. Especially since, as released to Mediapart by the Ministry Delegate for Industry, at the start of 2021, « an abandonment of the company gives rise, in the same way as the failure to obtain the marketing authorization , at the early termination of the contract, with similar consequences: we are disengaged from any future payment and, for the deposit already paid, this gives rise either to the reimbursement (partial or full, depending on the case) of the deposit paid (…)”. Asked by us to confirm the existence of this clause, the Ministry for Industry referred us to the Ministry of Health, which states that « these contractual elements are confidential and cannot be communicated ».
The Reuters agency indicated, in September 2020, that the European Union had paid a deposit of 324 million euros to Sanofi. Contacted, the French laboratory does not confirm. His answer: “We are producing the volumes necessary to meet the demand of the current advance purchase agreements. We will deliver 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 covid is not linked to financial gains”.