Valneva’s share price fell by over 25% on Monday after the French drugmaker gave a dire outlook for its floundering COVID-19 vaccine deal with the European Union, and warned it may need to stop making the vaccine entirely.
Unlike the cutting-edge mRNA-based COVID vaccines from Pfizer/BioNTech and Moderna, Valneva’s jab takes the more traditional approach of stimulating an immune response with a killed-off version of the virus.
Because it uses the whole virus rather than just focusing on its spike protein, the hope was that it could prove useful against many coronavirus variants.
Valneva’s first big order came from the U.K.—its factory is in Scotland—but the British government dealt the company a huge blow in September, when it canceled the 100-million-dose contract. The Brits claimed the decade-old firm had breached its supply obligations, and Valneva’s share price dropped 45%.
Meanwhile, talks with the EU ran hot and cold. Valneva broke off negotiations with the European Commission in April 2021 due to a lack of “meaningful progress”, but in November it won an advance purchase agreement for up to 60 million doses, to be delivered this and next year.
The deal gave the Commission the right to pull out if the European Medicines Agency (EMA) had not approved Valneva’s vaccine for use by the end of April. That turned out to be the case—the process was held up by an EMA request for more information—and the Commission told Valneva in mid-May that it would terminate the agreement.
Valneva tried to rescue the deal by proposing a remediation plan, but late Friday it admitted things were not going well. It said that, while some EU countries were still interested, the Commission was not indicating enough volume to “ensure the sustainability of Valneva’s COVID-19 vaccine program.”
The firm’s share price fell by more than 25% on Monday, before trimming some of those losses—at the time of publication, it was 15% down. The terms of the scrapped agreement allow Valneva to keep the EU’s down payment, representing around 30% of the order value.
Valneva’s COVID vaccine has been shown to be effective against the Omicron variant—news of which gave the share price a 45% bump back in January.
However, it has so far only been green-lit by regulators in the U.K., the United Arab Emirates, and Bahrain. The latter country bought a million doses and started rolling them out in April; as yet, it’s the only one to do so.
“We hope that the [European Commission] and its member states will continue to evaluate the potential advantages of an inactivated vaccine,” said CEO Thomas Lingelbach in Friday’s statement.
“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.”
There had been hopes that the rollout of more traditional vaccines would make a serious dent in the proportion of Europeans who have not been vaccinated against COVID—around a quarter have yet to receive a single dose.
However, the experience of Novavax’s protein-based COVID vaccine suggests otherwise, with low takeup in places like Germany.
The EMA continues to evaluate Valneva’s vaccine and will likely give its recommendation on its deployment next week. Apart from that product, Valneva’s portfolio also includes travel vaccines against cholera and Japanese encephalitis.
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