With Valneva’s inactivated COVID-19 vaccine candidate stalled in the regulatory process, the European Commission has pulled the plug on its advance purchase agreement for the shot.
Once believed to have blockbuster potential, Valneva’s COVID-19 vaccine now faces an uncertain future. Under the prior supply contract, Valneva was set to provide 60 million doses over two years.
It’s not quite a done deal. The French vaccine maker has until June 12 to obtain marketing authorization or propose an alternative remediation plan to provide the shot to member states who still wish to receive it.
The EC decision, coupled with the implosion of a supply agreement with the U.K. in September of last year, leaves Valneva with a limited market for its jab. The deal with Britain would have been worth $1.65 billion over five years.
Since December, the European Medicines Agency has been conducting a rolling review of the vaccine. On April 25, the EMA’s Committee for Medicinal Products for Human Use (CHMP) asked Valneva for additional data and answers to several questions. The company responded quickly but two weeks later, Europe canceled the supply deal.
“The EC decision is regrettable especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution,” Valneva CEO Thomas Lingelbach said in a release. “We have started a dialogue with member states who are interested in our inactivated approach. Valneva continues to believe that its vaccine candidate VLA2001 can make an important contribution to the fight against COVID-19.”
Two weeks ago, the company unveiled the start of a trial to measure the effectiveness of its vaccine as a booster. The company said on Monday that it still expects a positive opinion on the shot from the CHMP next month.
The U.K. granted conditional marketing authorization to the shot last month. The Valneva vaccine has also been approved for emergency use in Bahrain.