The French biotech Valneva has filed for initial approval of its COVID-19 vaccine candidate from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). The move, which Valneva hopes will result in a green light by year-end, boosted its share price by over 5%.
Although it hails from the continental side of the English Channel, Valneva’s big existing contract—for 100 million doses in 2021 and 2022, with the option for another 90 million through 2025—is with the British government, and the sole manufacturing site for its potential COVID-19 vaccine is in Scotland.
Announcing the move Monday, Valneva said the top-line results for its large-scale Phase III trial were likely to emerge early in the fourth quarter. As has become standard practice in the pandemic, in order to speed up the process, Valneva on Monday launched a “rolling submission” for authorization, meaning the drug regulator will consider data as it becomes available, rather than all at once after trials conclude.
“We are pleased to begin the regulatory review process for our COVID-19 vaccine with the MHRA,” said the company’s chief medical officer, Juan Carlos Jaramillo, in a statement. “We are working hard to make our vaccine candidate available as soon as possible.”
At the time of publication on Monday afternoon, European time, Valneva’s share price had risen 5.8% on the news of its application.
As one of the latecomers to the COVID-19 vaccine game, Valneva’s vaccine (VLA2001) would probably be used as a booster; a U.K.-government-funded clinical trial is evaluating it and other candidates for this purpose.
VLA2001 is the only vaccine candidate being evaluated in Europe that is based on a killed-off version of the SARS-CoV-2 virus itself. Because it takes this broader (and relatively traditional) approach rather than focusing on the virus’s spike protein, it could be that it proves successful in handling variants where the spike protein has significantly mutated.
Back in April, talks between Valneva and the European Commission broke down because, the EU executive said, the company failed to meet “a certain set of conditions.” Valneva’s prioritization of the U.K.’s order was reportedly a factor, and the subsequent resurrection of the talks in late June suggested that the EU no longer saw this as a blocker.
However, Valneva still has no EU purchase agreement. “Valneva continues to have productive discussions with the European Commission,” a spokesperson said Monday, declining to give any further details.
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