Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.
The Company also announced positive homologous booster results at the end of December 20213. The data showed an excellent immune response after a third dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. Valneva is also evaluating the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with licensed COVID-19 vaccines or following natural COVID-19 infection.
VLA2001 is also being evaluated in elderly and adolescent volunteers. The Company expects to report topline data for the elderly trial in the coming weeks.
https://finance.yahoo.com/news/valneva-confirms-clinical-trial-regulatory-060000273.html
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