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.
