Valneva SE announced that it has received a notice from the European Commission of intent to terminate the advance purchase agreement (“APAâ€) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate VLA2001.
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The APA provides the EC with a right to terminate the APA if VLA2001 had not received a marketing authorization from the European Medicines Agency by April 30, 2022. Based on the terms of the APA, Valneva has 30 days from May 13, 2022 to obtain a marketing authorization or propose an acceptable remediation plan.
The Company will work with the EC and the participating EC member states to agree to a remediation plan and to make VLA2001 available to those member states who still wish to receive it.
The Company announced on April 25, 2022 that it received a further List of Questions from the Committee for Medicinal Products for Human Use (“CHMPâ€) of the EMA.
Valneva submitted its responses on May 2, 2022 and believes that they adequately address the remaining questions. If the CHMP accepts Valneva’s responses, the Company would expect to receive a positive CHMP opinion at the latest in June 2022.
If the EC ultimately terminates the APA, Valneva will not be required to return the down payments received since Valneva has committed the full amount of those down payments and the APA does not require reimbursement of such payments under these circumstances.
Valneva SE announced that the United Arab Emirates granted emergency use authorization for Valneva’s inactivated, adjuvanted COVID-19 vaccine, VLA2001.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this new authorization and would like to thank the UAE for their trust and confidence. As the only dual-adjuvanted, whole-virus inactivated COVID-19 vaccine approved by the UAE Ministry of Health and Prevention, VLA2001 could offer an alternative vaccine solution to people across the Emirates. This is our second approval in the Gulf countries, and we are hoping that further approvals of VLA2001 will follow elsewhere.â€
This authorization follows Conditional Marketing Authorization from the UK MHRA[1], which was granted last month, and emergency use authorization from the Bahraini NHRA in March 2022.
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 Corporation is a component of the US 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). ■