Valneva confirms timelines for Covid-19 vaccine trial and regulatory filing
06 Jan 2022 (Last Updated January 6th, 2022 14:44)
The company plans to commence a heterologous booster trial of VLA2001.
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Valneva signed a deal in November 2021 to supply up to 60 million doses of its vaccine to the European Commission. Credit: © Valneva SE.
Valneva has confirmed the previously reported clinical trials and regulatory submission schedules for its Covid-19 vaccine candidate, VLA2001.
An inactivated, adjuvanted whole virus vaccine VLA2001 could be used for active immunisation of at-risk people for preventing disease carriage and symptomatic infection.
The company anticipates obtaining potential regulatory approvals for the vaccine in the first quarter of this year.
As reported last December, Valneva initiated rolling submissions seeking initial approval for the Covid-19 shot with the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Bahrain National Health Regulatory Authority (NHRA).
Furthermore, the company is working with the regulatory authorities to conclude the review process following positive data from the
Phase III trial of the vaccine.
During the same period, the company reported positive trial data from homologous boosting with the vaccine.
Findings showed that excellent immune responses were observed on administering a third dose seven to eight months following the second dose of the primary inoculation series.
Valneva is also analysing the sera obtained from the boosted subjects for cross-neutralisation against SARS-CoV-2 variants, including Omicron.
Parallelly, a heterologous booster trial is expected to be launched to evaluate the booster dose of VLA2001 given a minimum of six months following primary dosing regimen with licensed Covid-19 shots or after natural infection.
In addition, the vaccine is being studied in elder and adolescent subjects with topline results from the elderly study anticipated soon.
Valneva CEO Thomas Lingelbach said: “In recent weeks, we have been receiving even more messages every day from people around the world who would like to be vaccinated with an inactivated vaccine and want to know more about VLA2001.
“We continue to believe that our inactivated vaccine candidate could be an important component of the fight against Covid-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can.”
Last November, Valneva entered a deal to deliver up to 60 million doses of the vaccine over two years to the European Commission.