Sera from 30 participants in the Phase 1/2 trial VLA2001-201 were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the Delta and Omicron variants.
All samples presented neutralizing antibodies against the ancestral virus and Delta variant, while 87% presented neutralizing antibodies against the Omicron variant, said the company.
Juan Carlos Jaramillo, chief medical officer of Valneva, said the results add to earlier findings from the company’ Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and a broad T-cell response.
The French company anticipates receiving regulatory approvals for its vaccine within the first quarter of 2022. It is continuing to submit data to the European Medicines Agency (EMA) as well as to the regulators in the UK and Bahrain.
The French company’s COVID-19 vaccine development had previously been underpinned by a development, manufacturing and supply contract with the UK government worth €1.4bn ($1.65bn) over five years: but, in September 2021, the UK cancelled the contract over an alleged breach of supply agreement obligations (accusations which Valneva ‘strenuously denies’).
Pivoting its efforts, the company then secured a supply agreement with the EU.
The deal with the European Commission, announced at the end of November 2021, will now see it supply up to 60 million doses to the EU over two years, including 24.3 million doses this year.
In December 2021, the vaccine maker said it was in talks with Scottish Enterprise for a multi-million pound grant which would enable it to fully complete its strategic manufacturing site in Livingston, Scotland.
“Following the termination of the supply agreement with the UK government… Valneva and Scottish Enterprise have since engaged in a highly constructive dialogue, and under the proposed grant, the Livingston site will be fully developed as a key vaccine production site for the long term.”
The manufacturer also revealed last month that it had secured agreement to supply 1m doses of VLA2001 to Bahrain, with deliveries planned in the first quarter of 2022 subject to it getting the regulatory greenlight.