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Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority and EMA.
December 8, 2021
By: Kristin Brooks
Managing Editor, Contract Pharma
Valneva SE signed an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Company’s inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare. Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority (NHRA). Franck Grimaud, Chief Business Officer of Valneva, commented, “We are grateful to the Bahraini government for their trust and confidence in our vaccine and are eager to work with them to start helping to address the pandemic evolution in the Middle-East. Subject to regulatory review and approval, we plan to start deliveries in the first quarter of 2022.” Last month, Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA20011. In October 2021 Valneva reported positive results from the Phase 3 trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. The trial recruited a total of 4,012 participants 18 and older across 26 trial sites in the UK. The trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 (AstraZeneca and the University of Oxford Covid vaccine), in terms of geometric mean titer for neutralization antibodies, (VLA2001 GMT 803.5 (95%), (AZD1222 GMT 576.6 (95%), as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination in adults aged 30 years and older.
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