Valneva [NASDAQ: VALN] Announces Regulatory Submission Timelines for its COVID-19 Vaccine Candidate

Valneva SE American Depositary Shares [NASDAQ: VALN] has approved the earlier conveyed timelines of its clinical studies and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Earlier, the company disclosed the positive homologous booster results at the end of December 2021.

The Company has started submissions for initial authorization of VLA2001 with the EMA, the UK MHRA, and the Bahraini NHRA as confirmed by the company in December 2021. It would continue to work closely with those bodies to end its review process after its positive Phase 3 trial results. Valneva is looking forward to possible regulatory authorization in the first quarter of 20221.

Furthermore, Valneva is also assessing the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron. Concurrently, the Company is getting ready to roll out a dedicated heterologous booster trial, which will assess a VLA2001 booster shot if at least six months after primary vaccination with certified COVID-19 vaccines or after a natural COVID-19 infection.

In addition, Valneva disclosed in November 2021 that the European Commission inked an agreement for the Company to provide up to 60 million doses of VLA2001 over two years. It includes 24.3 million doses in 2022. Delivery of the vaccine is currently due to start in April 2022, dependent on authorization by the EMA.