(Boursier.com) — Valneva has received an initial assessment from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its inactivated and adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva has received a list of questions and is confident that it will be able to answer them in the coming days.
Following the Company’s responses, the EMA will send it a timetable for a possible conditional market authorization.
Subject to acceptance of Valneva’s responses and the timeline provided by the EMA, Valneva expects to receive a positive recommendation from the CHMP for conditional authorization of VLA2001 as a primary series in adults aged 18 to 55 at the end of 1st quarter 2022.
After this authorization, Valneva plans to make its first deliveries of VLA2001 to European countries at the beginning of the second quarter of 2022.
“We are pleased with this initial assessment from the CHMP and look forward to providing them with our responses. VLA2001 is the only COVID-19 vaccine in clinical development in Europe and this assessment brings us closer to our goal of being able to provide an alternative vaccine. to the populations and doctors who need it. Adults aged 18-55 represent the vast majority of unvaccinated people in Europe and we continue to receive many messages every day from them asking us for a more traditional and proven vaccine solution. “, comments Thomas Lingelbach, Chairman of the Management Board of Valneva,
Recall that Valneva is currently conducting additional clinical trials with the aim of expanding the indications of VLA2001 to other age groups and to potentially be able to use the vaccine as a booster dose in the year 2022.
Valneva has signed an agreement with the European Commission for the supply of up to 60 million doses of VLA2001 for a period of two years, including 24.3 million doses in 2022. Valneva has started production of doses of VLA2001 for the European Commission and the Kingdom of Bahrain and has stocks ready to be labeled and distributed as soon as regulatory authorization is obtained.