The 100 million doses planned will never arrive. The Franco-Austrian laboratory Valneva has “received a notice of termination” from the British government concerning the “supply agreement” of its candidate vaccine against the coronavirus, he announced.
in a press release published on Monday.
“The contract includes a clause allowing the British government to terminate it. He also claims that Valneva failed to meet its obligations, which Valneva vigorously contests, ”said the laboratory, based near Nantes (Loire-Atlantique). Why did the UK take this decision? What will be the consequences ? 20 minutes make the point.
How many doses were expected?
Shunned by France and the European Union, the Franco-Austrian laboratory Valneva signed an agreement with the United Kingdom for 60 million doses in September 2020, then for another 40 million in February 2021. In total, nearly 100 million doses were expected for 2021-2022.
This country “responded first, probably largely because we were already there, and also because they immediately believed in our inactivated vaccine. They were the first to react and to give us a structured offer of help. They took all the risks on the program, ”welcomed Franck Grimaud, CEO of Valneva at the start of the year, which uses a deactivated virus vaccine, a technology more traditional than RNA, and which serves in particular for flu shots every year.
“Valneva has worked tirelessly, and invested to the maximum of its abilities”, in its collaboration with the British government, “in particular by committing significant resources and by showing a very strong implication in order to respond to [ses] requests for vaccines suitable for variants, ”explains the laboratory in its press release.
Where were the authorizations?
According to the press release, the results of phase III trials, intended to prove the real effectiveness of a treatment before a possible marketing at the end of 2021-beginning of 2022, “are expected at the beginning of the fourth quarter”. At the end of August, after the phase I and II trials, the laboratory had indicated that it hoped “to have a vaccine which is effective in a manner greater than 80%”. “We will have to demonstrate this in the phase III trial”, then underlined its managing director Franck Grimaud.
These results were to “be part of the progressive submission of the application for conditional authorization of VLA2001 to the British health agency”. Subject to phase III results and approval from the UK health agency, Valneva believed “that an initial marketing authorization for VLA2001 could be obtained by the end of 2021”.
Why did the UK terminate the contract?
In its statement, released on Monday, Valneva announced that the British government had terminated the contract for 100 million doses of vaccine, but the reasons remain unknown for the moment. The Franco-Austrian laboratory only indicated that “the contract includes a clause allowing the British government to terminate it” and that the latter claims that the biotech “has failed in its obligations”, without further details.
For Nathalie Coutinet, health economist and teacher-researcher at Paris-13 University, interviewed by 20 minutes, several hypotheses are possible: “It may be a manufacturing delay, a vaccine safety problem, a cost that is ultimately too high, supply difficulties, a necessary budget extension” , explains the specialist.
“It’s quite new and surprising that a country breaks a contract overnight. The UK government is talking about a breach, so something has happened. I think it is a problem of relations or deadlines, ”explains Nathalie Coutinet. For the economist, perhaps “the game is no longer worth the candle”. As the Valneva vaccine is still in phase III, there are several months before it can be put on the market. “It may ultimately be too expensive, when we have other vaccines, like Pfizer, which are safe and can be manufactured quickly in large quantities,” continues the teacher.
For Rafi Mardachti, CEO of Universal Medica Group, a consulting company in the pharmaceutical industry, it is more “a political decision than a medical and scientific position”. “When we look at its results, Valneva is far from being ridiculous and is defending itself very well in terms of effectiveness” against the Covid, he told AFP.
What are the consequences of this decision for the firm?
This is a hard blow for the Franco-Austrian firm, which fell very heavily at the opening of the Paris Stock Exchange on Monday morning, losing more than 40% of its price, to 12,098 euros. But if the contract with the United Kingdom seems badly off, the laboratory could try its luck with other countries. In its statement, Valneva said that it “continues to be fully engaged in the development” of its vaccine candidate and that it “will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the pandemic ”.
At the end of August, Franck Grimaud had also affirmed that discussions with the European Union were also “still in progress”. However, for Nathalie Coutinet, the chances that Valneva will get a contract with the European Union are relatively low. “The Sanofi vaccine will arrive within a few months, it is a huge competitor for Valneva, the giant of the pharmaceutical industry has much larger production capacities. It seems unlikely, ”analyzes the economist.