(Photo credits: Valneva Group -)
(AOF) – Valneva today announced positive initial results for the pivotal Phase 3 Cov-Compare trial of its inactivated and adjuvanted Covid-19 vaccine candidate, VLA2001. The latter successfully fulfills the two main evaluation criteria of the trial. It produces higher antibody titre levels compared to AstraZeneca vaccine. The neutralizing antibody seroconversion rate is greater than 95%.
VLA2001 elicited a broad T cell response producing specific interferon gamma against the S, N and M proteins.
VLA2001 was well tolerated, demonstrating a statistically significantly better safety profile than that of the comparator vaccine.
Thomas Lingelbach, Chief Executive Officer of Valneva, said: “These excellent results confirm the benefits often associated with inactivated whole virus vaccines. We are committed to registering our differentiated vaccine candidate as quickly as possible and continue to believe that we could make a major contribution to the global fight against the Covid-19 pandemic “.
Valneva has started the gradual submission of the initial authorization application dossier to the UK Health Agency (MHRA) and is preparing to begin phased submission to the European Medicines Agency (EMA), as part of a request for conditional authorization.
A final validation of one of the assays used in the assay was required by the MHRA in order to verify the integrity of the data from VLA2001-301. This validation is currently underway and is a prerequisite for the final submission of the clinical study report.
The group is preparing a trial in children (5 to 12 years old) and a booster vaccination trial to assess the performance of VLA2001 in people in need of a booster.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: testing of the molecule on a small scale in humans to assess its safety, tolerance, metabolic and pharmacological properties.
Phase II: safety and efficacy evaluation on several hundred patients to identify side effects.
Phase III: evaluation of the overall benefit / risk ratio in several thousand patients.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7 billion euros): 1.5 billion for university hospital research, 2 billion for investment in health via bpi France , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenses reimbursed by Medicare will be 2.4%, which should generate at least 0.5% growth in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.