EU sets out intention to terminate COVID-19 vaccine deal with Valneva
The vaccine candidate is currently under review by the European Medicines Agency (EMA), but authorization has not yet been received. Under the terms of the Advanced Purchase Agreement, the EC has the right to terminate the agreement if marketing authorization from the EMA was not received by April 30.
Based on the terms of the APA, Valneva has 30 days from May 13 to either obtain a marketing authorization or propose an acceptable remediation plan.
The inactivated vaccine candidate has received authorization for use from several jurisdictions - notably the UK, Bahrain and UAE – but the deal with the EU would cover up to 60 million doses over two years.
EU agreement crumbles 18 months after UK deal
Valenva’s COVID-19 vaccine was initially focused on the UK market with a development, manufacturing and supply contract with the UK Government worth $1.65bn over five years, but this was cancelled by the UK in September 2021.
Pivoting its efforts, the French vaccine specialist secured a supply agreement with the EU, initially hoping to see authorization and distribution happen in Q1, 2022. It started a rolling review for the vaccine with the EMA in December.
In an update in April, Valneva confirmed it had received a further List of Questions from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its application, but remained upbeat a positive opinion was forthcoming. It submitted the required responses on May 2, and says it ‘believes that they adequately address the remaining questions’.
If the responses are accepted by the CHMP, then Valneva anticipates a positive opinion by June 2022 ‘at the latest’.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
It is produced on Valneva’s 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.
In addition to its applications and authorizations for the vaccine as a primary series, the company has started trials this month for VLA2001 as a booster after mRNA vaccination or natural infection.
A statement from the company confirms it 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.
Thomas Lingelbach, CEO, Valneva, commented: “The EC decision is regrettable especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution. We have started a dialogue with member states who are interested in our inactivated approach.
"Valneva continues to believe that its vaccine candidate VLA2001 can make an important contribution to the fight against COVID-19 and complement existing vaccines with an inactivated, whole virus approach”.
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.
Based on the outcome of the discussions with the EC and the relevant member states, Valneva will reconsider its full-year 2022 financial guidance.
