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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