CORONAVIRUS: EMA ASKS VALNEVA FOR ADDITIONAL DATA ON ITS VACCINE CANDIDATE
PARIS (Reuters) – Valneva announced on Monday that it had received a new list of questions from the European Medicines Agency (EMA) about its candidate vaccine against COVID-19, for which the French laboratory still hopes to obtain the marketing authorization during this quarter.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is in particular calling for new data and additional justifications for a conditional marketing authorization, said Valneva, which intends to answer these questions “in the coming days”. .
“We are disappointed that the EMA has not considered our submissions to be sufficient to date. We remain fully committed to working jointly with the regulatory authorities towards the marketing authorization of the product”, said the Chairman of the Management Board of Valneva, Thomas Lingelbach, quoted in a press release.
(Written by Bertrand Boucey, edited by Myriam Rivet)