VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe
Valneva, a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.
With this approval, VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe. The marketing authorization will cover all 28 European Union Member States as well as Iceland, Liechtenstein, and Norway.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased that the EC granted full marketing authorization for VLA2001, the only inactivated whole-virus COVID-19 vaccine available in Europe. Once again, we have shown that Valneva has the expertise to bring a vaccine all the way from bench to market. Since we began working on VLA2001, we have continued to receive messages from Europeans who are waiting for a more traditional vaccine technology. Now that we have received this full marketing authorization, we hope that the EC and its member states will place orders that reflect this demand. 15% of Europeans over 18 are not yet vaccinated, and we believe that making our inactivated vaccine available could increase vaccination coverage and have a meaningful impact on public health.”
The EC’s approval follows recommendations yesterday from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization. This new marketing authorization in Europe follows conditional marketing authorization in the United Kingdom, which was granted in April 2022, and emergency use authorization granted in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.