Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001

Valneva SE confirmed that the European Medicines Agency (EMA) has started a rolling review of VLA2001, its whole-virus inactivated, adjuvanted COVID-19 vaccine candidate.

Valneva remains focused on achieving regulatory approvals of VLA2001 following its positive Phase 3 trial results. The Company continues to make progress with the rolling submission in the UK (MHRA), including verification of the Phase 3 clinical data integrity (required for finalization of the submission), as previously disclosed. Potential regulatory approvals are expected in the first quarter of 2022.

Valneva is also providing an update on VLA2001 in the context of the emergence of the Omicron variant. Valneva believes that VLA2001 can make an important contribution to the global fight against the COVID-19 pandemic and potentially play a role in protecting against the new Omicron variant.

In contrast to other vaccines that target only the spike protein of the SARS-COV-2 virus, VLA2001 is developed using the entire SARS-CoV-2 virus envelope. Preserving the whole virus envelope is expected to elicit a broad immune response and together with the CpG1018 adjuvant may provide an improved immunological profile by boosting T-cell responses against additional SARS-CoV-2 proteins. Valneva will test for cross-neutralization of VLA2001 against the Omicron variant.

Valneva also confirms that its technology platform is adaptable for new variants, if required. The Company has undertaken laboratory development and testing of variants, at its sites in France and Austria, including the production of viral seed stock for three earlier variants of concern, including Delta. Valneva produced a full scale pilot lot derived from the Alpha variant, validating the suitability of its well-established manufacturing process for variant-based vaccines.

Valneva has commenced manufacturing for the European Commission supply contract and has some inventory ready for labelling and deployment upon regulatory approval. Valneva expects to have capacity to produce over a hundred million doses of vaccine per annum through a combination of in house production and CMO capacity.

Commenting, Thomas Lingelbach, Chief Executive Officer of Valneva, said, “The latest COVID-19 wave in Europe underlines the need for additional vaccines and we continue to believe that VLA2001 will contribute to addressing the pandemic. We are hopeful that our vaccine candidate might cross protect against variants to the SARS-CoV-2 virus and also have the flexibility, knowledge and resources to adapt if required. Our teams are working diligently to achieve regulatory submissions so that we can quickly deploy our vaccine and ensure that it reaches people who need it.”