Valneva SE was granted emergency use authorization by the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain for its 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.

 
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.
 
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 1Q22.
 
VLA2001 is currently the only whole virus, inactivated, adjuvanted COVID-19 vaccine in clinical development in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination including addressing new variants. Further, VLA2001 could potentially be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO. 
 
VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies, is a component of the U.S. FDA- and EMA-approved HEPLISAV-B vaccine. 
 
VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).