(AOF) – Valneva has finalized the recruitment of seniors for the first cohort of its phase 3 trial, VLA2001-304, for its inactivated Covid-19 vaccine candidate, VLA2001. 300 volunteers aged 56 years and over were recruited from New Zealand in the VLA2001-304 trial with the objective of generating additional safety and immunogenicity data for this age group. The number of participants recruited from this cohort was increased from 150 to 300 in consultation with the European Medicines Agency (EMA).
Initial results for this cohort are expected to be available in early 2022, and this data could be provided to support further regulatory submissions.
Juan Carlos Jaramillo, MD, Medical Director of Valneva, said, “We started this trial about a month ago, so we are extremely pleased to have taken this important step in such a short time. We believe our candidate vaccine, by virtue of its technological difference, can make a major contribution to the current fight against the Covid-19 pandemic. ”
VLA2001 is currently the only inactivated and adjuvanted vaccine candidate against Covid-19 in clinical development in Europe. In parallel with the VLA2001-304 trial conducted in New Zealand, VLA2001 is currently being evaluated in the pivotal Phase 3 “Cov-Compare” trial (VLA2001-301) in the United Kingdom (UK) for which initial results are awaited. at the start of the fourth quarter of 2021.
Valneva has started the gradual submission of the marketing authorization dossier to the British health agency MHRA for its inactivated vaccine against Covid-19.
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 growth of at least 0.5% in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.