(BFM Bourse) – Has the UK government obtained any adverse information regarding the efficacy or safety of VLA2001? The statements of the British Minister of Health to justify the termination of the contract with the Nantes biotech raised suspicions on Tuesday in this direction. The principal investigator of the phase 3 “Cov-Compare” trial assures that to date nobody knows the content of the results, expected at the beginning of the fourth quarter.
It’s a bit like Schrödinger’s cat experiment applied to biotechnology. Asked Tuesday in Parliament on the reasons for the termination of the supply contract previously concluded with the French biotech Valneva (whose main production site is in Scotland), the Secretary of State for Health and Social Protection Sajid Javid highlighted a probable refusal by the competent agency, the Medicines and Healthcare products Regulatory Agency (MHRA).
“There are business reasons why we canceled the contract, but it was also clear to us that the vaccine in question developed by the company would not gain MHRA approval here in the UK,” he said. Sajid Javid (former investment banker, minister several times under Cameron, May then Johnson), without specifying on what bases this assertion was based, the agency in question not having pronounced itself. And for good reason, since the clinical trials, the results of which must feed the approval file, are still in progress.
Results that will not fall until the beginning of the fourth quarter
While the firm reported in July that the data from the largest trial (VLA2001-301 or “Cov-Compare”, involving more than 4,000 volunteers) initially scheduled for September would not be available until the beginning of the fourth quarter, the minister did not blame any delay. His allusion to a probable refusal by the British drug agency has therefore raised fears, in particular to patients worried about being unknowingly deprived of protection against the virus, that the government had obtained unfavorable information as to the effectiveness or safety (even if phase 2 showed an encouraging seroconversion rate, it is still possible that a phase 3 trial will not confirm the potential of an experimental treatment). As a reminder, phase 3 is the last stage of clinical trials before the possible marketing of a product.
On Wednesday, the principal investigator of the VLA2001-301 trial, Adam Finn (professor of pediatrics at the University of Bristol, specializing in childhood infectious diseases, and European representative of the technical advisory group of experts on immunization of WHO) made it clear that “the research program on the vaccine against the Covid-19 of Valneva, with a view to authorization from the MHRA, is on track and continues to move forward. The main results of the phase 3 are expected at the start of Q4 (fourth quarter, editor’s note) and no one, Valneva included, is aware of it at this stage “. “Study participants can be reassured,” he added.
Another clinical trial on recalls
At the same time, the University of Southampton is conducting a trial evaluating various vaccine candidates, including VLA2001, as a booster in people over 50 who have already been vaccinated. This test called “Cov-Boost” should last a year in total, but with first results expected in September, so imminently.
Asked Tuesday in the afternoon show of Radio4 (one of the BBC’s antennas) by Evan Davis, Professor Saul Faust, principal investigator of this test, assured that no data emanating from Cov-Boost does not was behind the government’s decision. While refusing to comment on the possible outcome of one or the other of the vaccines tested in this specific context, adding that the data collection was not finished, the practitioner stressed that Cov-Boost no ‘was in any case not intended as a test intended to support a license application. “It is certainly not Cov-Boost which led to the declaration of the Secretary of State”, assured Saul Faust, also a specialist in immunology and pediatric infectious diseases in particular.
After a sharp drop on Monday of nearly 42%, the Valneva share recovered slightly on Tuesday (+ 8%) and continues its momentum on Wednesday (+ 2.70% around 3:15 p.m.). The price remains up 67% since the start of the year.
Guillaume Bayre – © 2021 BFM Bourse
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