Once promising an alternative shot, Valneva's Covid-19 supply deal with Europe on verge of collapse
When French vaccine maker Valneva signed a purchase agreement with the European Commission in November, execs touted how the deal — under which it would supply 60 million doses of its inactivated, adjuvanted whole-virus Covid-19 vaccine — offered an alternative to the mRNA and adenovirus-based shots already out there.
But the whole deal may be in jeopardy now.
The EC first sent a notice of intent to terminate the purchase agreement back in May, as the regulatory review of Valneva’s vaccine stalled. Despite proposing a remediation plan, Valneva disclosed Friday that the latest discussions suggest the chances of reaching a revised deal are slim.
Valneva shares (EPA: $VLA) plunged 26% to €7.70 on the Paris stock exchange.
While the EMA began its rolling review of Valneva’s shot in February 2021, regulators still had questions as recently as February. Under the original deal, the EC had a right to pull out of its purchase if Valneva had not received marketing authorization by April 30 — and it didn’t (although the UK did authorize it in mid-April).
In response to the EC’s notice of intent, Valneva proposed a remediation plan. However, the “preliminary, unofficial volume indications” the EC got from the few member states that expressed interest in the inactivated shot “would not be sufficient to ensure the sustainability” of the program, not to mention further development.
If those order numbers become final, Valneva suggested the reduction would be so drastic that it likely won’t enter into an amendment. That could spell an end to any access hopes.
In a statement, CEO Thomas Lingelbach said he hopes the EC and member states will reconsider.
“There is emerging evidence that hybrid immunity – from a combination of vaccination and natural infection – increases protection against development of severe Covid-19 caused by different variants of concern, and our inactivated vaccine closely mimics natural infection by exposing vaccines to the entire inactivated SARS-CoV-2 virus,” he said. “Additionally, market research studies in six European countries indicated material interest in an inactivated Covid-19 vaccine for primary or booster vaccination. We continue to receive messages from people looking for a more traditional vaccine technology and we hope to receive a meaningful order size to further support public health in Europe.”