When French vaccine maker Valneva signed a purchase agreement with the European Commission in November, executives touted how the deal – under which it would supply 60 million doses of its inactivated whole-virus Covid-19 vaccine and with adjuvant – offered an alternative to the mRNA and adenovirus-based vaccines already available.
But the whole business may be in jeopardy now.
The EC first sent a notice of intent to terminate the purchase agreement in May as regulatory review of Valneva’s vaccine stalled. Despite offering a remediation plan, Valneva revealed on Friday that the latest discussions suggest the chances of reaching a revised agreement are slim.
Valneva (EPA: $VLA) shares plunged 26% to €7.70 on the Paris Stock Exchange.
While the EMA began its ongoing review of Valneva’s firing in February 2021, regulators still had questions as recently as February. Under the original deal, the EC had the right to back out of its purchase if Valneva hadn’t received marketing clearance by April 30 — and it didn’t (although the UK authorized it in mid-April).
In response to the EC’s Notice of Intent, Valneva proposed a remediation plan. However, the “preliminary and unofficial volume indications” that the EC has obtained from the few Member States that have expressed interest in inactivated shot “would not be sufficient to ensure the sustainability” of the programme, let alone its further development.
If those order numbers become final, Valneva suggested the reduction would be so drastic that it likely won’t fit into an amendment. This could spell the end of any hope of access.
In a statement, CEO Thomas Lingelbach said he hoped the EC and member states would reconsider their decision.
“There is emerging evidence that hybrid immunity – derived from a combination of vaccination and natural infection – increases protection against the 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 in six European countries has indicated material interest in an inactivated Covid-19 vaccine for primary or booster vaccination. We continue to receive messages from people looking for more traditional vaccine technology and we hope to receive a significant order size to further support public health in Europe.