Valneva SE (NASDAQ: VALN) confirmed that the European Commission (EC) has given notice of its intention to terminate the advance purchase agreement (APA) for Valneva's inactivated whole-virus COVID-19 vaccine candidate VLA2001. If VLA2001 does not get a marketing license from the (EMA) before April 30, 2022, the EC has the power to terminate the APA.
Valneva has 30 days from May 13, 2022, to get a marketing authorization or provide an appropriate repair plan under the conditions of the APA. The Company will collaborate with the European Commission and participating EC member states to develop a remediation strategy and make VLA2001 available to those member states who still want it.
The Company stated that it had received a new List of Questions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) On April 25, 20221. Valneva's replies were submitted on May 2, 2022, and the company thinks they fully address the outstanding questions. If Valneva's replies are accepted by the CHMP, the Company should expect a good CHMP opinion by June 2022.
Furthermore, VLA2001 earned Conditional Marketing Authorization from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom on April 14, 20222, as well as Emergency Use Authorizations from the UAE Ministry of Health & Prevention and Bahrain's National Health Regulatory Authority on May 13, 2022, and February 28, 20223, respectively.
The EC decision is regretful, said Thomas Lingelbach, CEO of Valneva, particularly as it continues to receive communications from Europeans asking for a more traditional vaccine approach. The company has started a discussion with member states that are interested in our inactive strategy. Valneva remains optimistic that its COVID-19 vaccine candidate VLA2001 will make a significant contribution to the fight against the virus, complementing current vaccines with an inactivated, whole viral approach.
Additionally, Valneva will not be obligated to return the down payments received if the EC dissolves the APA since Valneva has pledged the full amount of the down payments and the APA does not demand payback of such payments in these circumstances. Valneva will review its full-year financial projection for 2022 based on the outcome of its discussions with the European Commission and relevant member states.