EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The European Medicines Agency (EMA) has accepted Valneva’s marketing authorisation application (MAA) for its COVID-19 vaccine candidate, VLA2001.

The COVID-19 vaccine candidate can now move from the initial rolling review process to the formal review process, which is overseen by the Committee for Human Medicinal Products (CHMP).

Valneva’s vaccine candidate is currently the only whole virus, inactivated, adjuvanted candidate for COVID-19 in clinical trials in Europe.

The vaccine is intended for active immunisation of vulnerable populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic. It is also hoped that it will be used for routine vaccination and as means of addressing new variants.

VLA2001 also has the potential to be used as a booster, as repeat booster vaccinations have so far been proven to work well with whole virus inactivated vaccines.

If the CHMP accepts the company’s conditional MAA, Valneva would be looking for a positive CHMP opinion in June 2022.

Should this be the case and a positive opinion is issued by the CHMP, a review of the recommendation from the European Commission (EC) will follow, along with a final decision on the MAA.

If Valneva gets the grant from the EC, the centralised marketing authorisation would be valid in all EU member states, as well as in Iceland, Liechtenstein and Norway.

Commenting on the regulatory developments, Thomas Lingelbach, CEO of Valneva, said: “The EMA’s acceptance of the filing for VLA2001 is an important step toward product approval. We remain fully committed and dedicated to working jointly with the regulators, the European members states and the European Commission toward making a more traditional and established COVID-19 vaccine technology available to people in Europe.”