The European Medicines Agency (EMA) has begun a rolling review of Valneva’s VLA2001, a whole-virus inactivated, adjuvanted Covid-19 vaccine candidate.
Valneva stated that it is now focused on securing regulatory approvals for VLA2001 after the positive results from the Phase III trial.
The firm also added that it continues to make advancements with the rolling submission in the UK (MHRA), including verification of the integrity of the clinical data of Phase III trial that is needed for finalisation of the submission.
It expects to receive regulatory approvals in Q1 2022.
With regard to the emergence of the Omicron variant, the firm has also offered an update on the Covid-19 vaccine candidate.
It believes that VLA2001 could have an important contribution to the global combat against the Covid-19 pandemic and possibly help in safeguarding against the new Omicron variant.
VLA2001 is developed making use of the complete SARS-CoV-2 virus envelope.
By preserving the complete virus envelope, it is expected to draw a broad immune response and along with the CpG1018 adjuvant may even offer an improved immunological profile by bolstering T-cell responses against more SARS-CoV-2 proteins.
Valneva stated that it will test for cross-neutralization of VLA2001 against the new variant, while confirming that its technology platform, if required, is adaptable for new variants.
The firm is carrying out laboratory development and testing of new variants at its facilities in France and Austria. This includes viral seed stock production for three earlier variants including Delta.
It produced a complete scale pilot lot drawn from the Alpha variant and verifying the suitability of its manufacturing process for variant-based vaccines.
Valneva has begun production for the European Commission supply contract and has also kept some inventory ready for labelling and deployment on receipt of regulatory approval.
Valneva intends to have a capacity to manufacture more than a hundred million doses of vaccine annually through a mix of in house production and CMO capacity.
Valneva CEO Thomas Lingelbach 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.”