A manufacturer of one of the four COVID-19 vaccines currently under rolling review by the European Medicines Agency (EMA) received notice from the European Commission that the advance purchase agreement of over 24 million doses might be terminated.
The receipt of the notice was announced by French drugmaker Valneva on Monday (16 May), regarding its inactivated whole-virus COVID-19 vaccine candidate VLA2001.
Thomas Lingelbach, chief executive officer of Valneva, said, “the European Commission’s decision is regrettable, especially since we believe in the value of the product that we have developed”.
The decision was triggered by fact that VLA2001 had not received marketing authorisation from the EMA by April 30, 2022, which, based on the agreement, gives the right for the Commission to terminate the contract.
The decision was made by the vaccine steering board, which is composed of representatives of the Commission and member states. “This has indeed been a collective decision,” the Commission’s spokesperson said on Monday.
He continued: “This notification now triggers a process which will enable the company to respond to the board’s concerns, the steering board will only then take a final decision as to whether or not to terminate this contract. And of course, in this, in this framework, in the context of this process, the vaccine steering board will consider any remedial solution the company may propose.”
Now, based on the terms of the advance purchase agreement, Valneva has 30 days from May 13 to obtain a marketing authorization or propose an acceptable remediation plan.
Working with member states and Commission
Valneva said it will work with the Commission and the participating member states to agree to a remediation plan and to make VLA2001 available to those member states who still wish to receive it.
“We continue working very, very hard […] with those member states who would like to see this vaccine in their portfolio. And, as it’s very clear, we will try everything to come to an agreement with the Commission on an acceptable remediation plan while we continue focusing on the process with EMA and CHMP [EMA’s Committee for Medicinal Products for Human Use] to get approval,” Lingelbach said.
At the end of April, CHMP sent a further list of questions to Valneva, which were responded to by May 2, as is stated in the company’s press release.
“[Valneva] 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,” the press release said.
“Yes, we have not received a positive CHMP opinion in April. But at the same time, we are well advanced […] we really hope to get a positive CHMP opinion later by the June meeting,” Lingelbach assured.
The EU is still a priority
VLA2001 has already received conditional marketing authorisation in the United Kingdom and emergency use authorisations in the United Arab Emirates and Bahrain.
Lingelbach highlighted that despite reaching out to countries outside Europe, the EU is still a priority. “We have, of course, prioritised the EU and we are still prioritising the EU at this point in time because we still believe that there will be a substantial demand for VLA2001 within Europe”.
In Europe, VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials. It is intended for active immunisation as well as boosting.
“We believe that this vaccine can still play a role in the fight against the ongoing pandemic, but also as a basis and as a platform for the future endemic phases,” Lingelbach highlighted.
If the Commission ultimately terminates the advanced purchase agreement, Valneva will not be required to return prepayment that was around 30% of the price of 24.3 million ordered doses.
Peter Buhler, Valneva’s chief financial officer, said that “as such, we do not expect to run into any immediate cash constraints but we will, of course, continue to carefully monitor our cash situation”.
Based on the outcome of the discussions with the Commission and the relevant member states, Valneva will reconsider its full-year 2022 financial guidance.
[Edited by Nathalie Weatherald]