On Monday, the French vaccine company announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has asked for additional data and further justification for a Conditional Marketing Authorization for the vaccine. Valneva is in the process of responding to these requests.
The vaccine received its first emergency use authorization from Bahrain in March; followed by the green light from the UK’s regulator earlier this month.
24.3 million doses due in the EU this year
VLA2001 is an inactivated, adjuvanted vaccine candidate: championing a tried-and-tested approach to vaccination. A Phase 3 trial indicated that two doses of VLA2001 ‘induced superior neutralizing antibody levels and a significantly better tolerability profile compared to another EMA-approved vaccine’, according to the company.
Valneva signed an agreement with the European Commission in November 2021 to supply up to 60 million doses over two years, including 24.3 million doses this year.
In its FY2021 update in March, Valneva was anticipating a positive CHMP recommendation for conditional approval of VLA2001 this month. On this timescale, the company would expect to start delivering doses of the vaccine to European countries in the second quarter of 2022.
Speaking on Monday, Thomas Lingelbach, CEO of Valneva, said, “We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval. VLA2001 is the only inactivated COVID-19 vaccine candidate in Europe, and we continue to receive messages every day from people who are looking for a more traditional vaccine approach”.