Valneva’s Inactivated COVID-19 Vaccine Candidate Shown to Neutralize Omicron Variant

• Preliminary laboratory studies demonstrate that three doses of Valneva’s inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B.1.1.529 lineage) 
  
• 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

Saint Herblain (France), January 19, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva’s inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.

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 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant. The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our inactivated, adjuvanted whole virus vaccine and its ability to address currently circulating variants of concern. These results add to earlier findings from our 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. We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can.”

Valneva is continuing to provide data to the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency, and the National Health Regulatory Authority in Bahrain (NHRA) as part of the rolling submissions process for initial approval of VLA2001. The Company continues to expect to complete these submissions in time to receive potential regulatory approvals in the first quarter of 2022.¹