Europe Can Order Inactivated Whole-virus COVID-19 Vaccines

Valneva SE today announced that the European Commission (EC) had 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 standard marketing authorization for all 28 European Union Member States, Iceland, Liechtenstein, and Norway.

Thomas Lingelbach, CEO of Valneva, commented in a media statement issued on June 24, 2022, "We are extremely pleased that the EC granted full marketing authorization for VLA2001, the only inactivated whole-virus COVID-19 vaccine available in Europe."

"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.... as we believe that making our inactivated vaccine available could increase vaccination coverage and have a meaningful impact on public health."

This new marketing authorization in Europe follows conditional marketing authorization in the U.K., granted in April 2022, and emergency use authorization in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.

VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®.

VLA2001 consists of inactivated whole virus particles of the SARS-CoV-2 coronavirus with high S-protein density, combined with two adjuvants, alum and CpG 1018.

This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1.

Note: This media release was manually curated for mobile readership.