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Benzinga
Benzinga
Technology
Vandana Singh

Valneva Advances Booster Phase Of Its Cov-Compare COVID-19 Vaccine Trial

Valneva SE (NASDAQ:VALN) has started booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare. 

  • This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results. 
  • The data are not intended for the initial regulatory approval process, which Valneva expects to finalize in the coming weeks.
  • Related: Three doses of Valneva's COVID-19 Vaccine Neutralizes Omicron Variant, Lab Study Shows.
  • The trial extension will evaluate a booster dose of VLA2001 in adults aged 18 and above who received primary vaccination with two doses of VLA2001.
  • The trial will also include participants aged 30 and above who received two doses of AstraZeneca Plc's (NASDAQ:AZN) AZD1222. 
  • The VLA2001 booster vaccination will be given at least seven months after completing the primary vaccination series. 
  • Topline data is anticipated in Q2 of 2022.
  • Valneva announced the first positive homologous booster results in December 2021
  • In addition, Valneva plans to initiate a further dedicated heterologous booster-only trial of VLA2001 in the coming weeks. 
  • Valneva expects to complete rolling submissions in the U.K and Bahrain in time and receive potential regulatory approvals in Q1 of 2022.
  • Price Action: VALN shares are up 14.0% at $36.08 during the market session on the last check Tuesday.
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