(Reuters) -Valneva on Monday warned it may have to reassess its financial guidance after the European Commission informed the company of its intent to terminate an advance purchase agreement (“APA”) for its VLA2001 COVID-19 candidate vaccine.
“The EC decision is regrettable especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution,” CEO Thomas Lingelbach said in a statement.
“Based on the outcome of the discussions with the European Commission and the relevant member states, Valneva will reconsider its full-year 2022 financial guidance,” the French pharmaceutical manufacturer added.
Valneva signed a deal with the European Commission in November 2021 to supply up to 60 million doses of vaccine over two years, including 24.3 million doses in 2022.
That advance purchase agreement concluded at the end of last year provided the European Commission the right to cancel the deal if Valneva’s VLA2001 had not received marketing authorisation from the European Medicines Agency (EMA) by April 30, 2022.
Last month the European Medicines Agency (EMA) asked Valneva for more data on its COVID-19 vaccine. [L2N2WN083]
“Based on the terms of the APA, Valneva has 30 days from May 13, 2022, to obtain marketing authorisation or propose an acceptable remediation plan,” Valneva said, adding it had submitted its response to the EMA’s latest request on May 2.
“The company will work with the European Commission and the participating EC member states to agree to a remediation plan and to make VLA2001 available to those member states who still wish to receive it.
The whole-virus inactivated COVID-19 vaccine developed by Valneva relies on technology that has been used for decades, for instance in some shots against polio, influenza and hepatitis.
The approach involves growing the virus in a lab, then rendering it completely inactive so it cannot infect cells or replicate in the body, but can still trigger an immune response.
The shot is seen by some as having the potential to win over people wary of some vaccines which use newer mRNA technology.
(Reporting by Anait Miridzhanian and Benoit Van Overstraeten; editing by Kim Coghill and Jason Neely)
