Vaccine specialist Valneva has refinanced its debt and cut its revenue forecast for this year after the US FDA suspended the licence for its chikungunya vaccine Ixchiq saying the jab posed a danger to health.
In a business update published on Monday (6 October) the French company said the debt deal with Pharmakon Advisors means it would pay back its $215 million debt in late 2030, instead of early next year as previously planned.
It added that the agreement with Pharmakon included scope for additional borrowing up to a total of $500 million to fund business development.
At the same time, it warned that 2025 product sales would be between €155-170 million, compared with its previous forecast of €170-180 million.
It comes after the US Food and Drug Administration (FDA) said Ixchiq appeared to be causing chikungunya-like illness in vaccine recipients, and that there has been one death from encephalitis directly attributable to the vaccine.
The agency added the clinical benefit of the vaccine had not yet been verified in confirmatory clinical studies, and that its analysis showed the vaccine did “not have benefits outweighing risks”.
Ixchiq – which contains a weakened version of the live chikungunya virus – remains approved for use in the European Union, the UK, Canada, and Brazil.
The company has distribution deals with Serum Institute of India for Asia, and Instituto Butantan in Brazil for Latin America.
Valneva did not respond to a request for comment from The Global Health Report about the FDA suspension and its plans for the vaccine in other regions.
Alongside Ixchiq, the company also makes a vaccine for cholera and one for Japanese encephalitis.
