The contract includes a clause allowing the UK government to terminate it. He further claims that Valneva breached his obligations, which Valneva vigorously contests.
Valneva, in a press release
Since then, the explanations of the laboratory as of London are very fragmented, even non-existent: the laboratory has not spoken on the subject since Monday, and has not responded to our requests.
According to a spokesperson for Prime Minister Boris Johnson, there was a risk that the British health authorities would not approve the vaccine of Valneva. “The British health authorities were not relying on this product for the injections of the fall and the ‘winter:
There are business reasons why we canceled the contract, but what I can tell him is that it was also clear to us that this vaccine would not be approved.
Sajid Javid, UK Minister for Health
The Minister thus replied, without further details, to a Scottish MP. But no other information has filtered so far, which fuels doubts and speculation.
London first support, first party
Against Covid-19, Valneva is developing an inactivated virus vaccine, a more traditional technology than messenger RNA and which is used in particular for influenza vaccines each year.
The laboratory had submitted in August its request for authorization to the British health authorities for its vaccine candidate, VLA2001.
The United Kingdom was the first to support it, placing an order from it last year: first for 60 million doses, then 40 million more, for 2021-2022.
London had also largely funded clinical trials of Valneva’s vaccine, which is due to be produced in Livingston, Scotland.
Discussions with the European Union, on the other hand, had proved difficult from the outset. Interrupted, they had resumed at the beginning of the summer. And they are not called into question by the British defection, we assure the French side.
On the European side, the contractual negotiations conducted by the Commission on this contract are continuing (…) for deliveries in 2022
Bruno Le Maire, French Minister of the Economy
Several European countries, including France, are now relying on this vaccine to “diversify” vaccine coverage, the ministry said, stressing that it is an inactivated virus vaccine project.
Where are the trials at?
At the end of August, the biotech had indicated that, on the basis of the phase I and II trials (on a relatively small number of volunteers), it hoped “to have a vaccine which is effective in a manner greater than 80%”.
In the aftermath of the UK termination, Valneva announced that it had completed recruiting volunteers for its Phase 3 trial.
The laboratory recalls Monday that its results of phase III trials, the last on humans before a possible marketing, are expected at the beginning of the fourth quarter, potentially in a few weeks.
In my opinion, this is certainly more of a political decision than a medical and scientific stance: 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.
Rafi Mardachti, CEO of Universal Medica Group
Less efficient than expected?
The first results of phase 3 of the trials are therefore not expected before the last quarter. It is therefore impossible to know on what basis the British government considers that the vaccine would not have been approved …
According to immunologist Stéphane Paul, it is possible that intermediate phase 3 results have been transmitted to the British government, which would have considered that the efficacy was too low compared to AstraZeneca “.
This vaccine is of a “rather old technology”, he explains, likely to be less effective, in particular against the variant delta. But it could be used as a “booster”, for seasonal boosters or third doses, for example.
Other possible reasons?
The British press has detailed the multiple reasons which, in the contract between Valneva and the British government, are likely to be invoked.
Problems of “material security”, or even of “yield”, for example. It is true that Valneva, which specializes in “travel” vaccines, has never produced such quantities.
Financial difficulties such as insolvency and default, or even a takeover of the business, can also trigger termination, although none of them appear to be the case. Valneva’s finances are not in good shape, however – especially since the termination: its stock market price has collapsed by 20 to 12 euros, and its finances are limited.
Finally, in general the government can “tear up the contract” without penalties for more general reasons, such as proven violations of environmental, social or labor law, or non-compliance with tax laws. None of these reasons have been cited so far.