SAINT HERBLAIN: Valneva SE (Nasdaq: VALN), a specialty vaccine company, announced that the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valneva’s inactivated, adjuvanted COVID-19 vaccine, VLA2001.
This authorization follows a rolling review process with the Bahraini NHRA and reflects the NHRA’s initiative to support the authorization of COVID-19 vaccines.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this first authorization and would like to thank the Kingdom of Bahrain for their trust and confidence. We are looking forward to addressing the evolution of the pandemic in the Middle East and starting to deliver our first vaccines in the region. As the only dual-adjuvanted, inactivated COVID-19 vaccine approved in Bahrain, VLA2001 will provide a differentiated vaccine option to the Bahraini population and medical community.”
Valneva signed an advance purchase agreement with the Kingdom of Bahrain in December 2021 for the supply of one million doses of VLA2001. The Company expects to deliver the first shipments of VLA2001 to Bahrain at the end of this month.
Valneva remains focused on achieving additional regulatory approvals of VLA2001. On February 25, 2022, the Company announced that it had received an initial assessment of VLA2001 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Based on this assessment, and subject to the CHMP’s acceptance of Valneva’s responses to a list of questions and to the timetable to be proposed by the EMA, Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 in Europe for primary immunization in adults aged 18-55 at the end of the first quarter of 2022.