French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate.
The firm announced on February 25 that CHMP had sent the company a series of questions as part of its initial assessment, to which it responded within two working days.
It anticipates that it can swiftly respond to the latest batch of questions.
Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.
In such a case, the company would supply European countries with the vaccine in the second quarter of the year.
Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.
The company says the COVID-19 vaccine is the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials in Europe.
Earlier this year, the company’s stock surged after it announced its vaccine neutralized omicron in neutralizing antibody study.