Valneva Receives Initial CHMP Assessment of its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided an initial assessment of Valneva’s inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

Valneva said that it has received a list of questions from the CHMP and is confident that it will be able to respond to these in the coming days. Following the Company’s response, the EMA will provide a timetable towards anticipated conditional approval.

Subject to the CHMP’s acceptance of Valneva’s responses and the EMA’s timetable, Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age at the end of the first quarter of 2022. Following such conditional approval, the company said that it would expect to deliver the first shipments of VLA2001 to European countries early in the second quarter of 2022.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are pleased with the initial CHMP assessment and look forward to providing our responses as soon as possible. VLA2001 is the only inactivated COVID-19 vaccine in clinical development in Europe, and this brings us closer to our objective of providing a differentiated vaccine option to the population and physicians who need it. Adults aged 18 to 55 represent the vast majority of unvaccinated people in Europe, and we continue to receive messages every day from many who are looking for a more traditional and established vaccine approach.”

The company said that it is currently conducting additional clinical studies aiming to gradually expand the label and indications of VLA2001 to further age groups, including for potential use as a booster vaccine in the course of 2022.

Valneva said that it has signed an agreement with the European Commission (EC) in November 2021 to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 2022. Valneva has commenced manufacturing for the EC and Bahraini supply contracts and has inventory ready for labelling and deployment upon regulatory approval.