French vaccine maker Valneva launches phase 3 trial of its COVID-19 vaccine after snubbing the EU
French biotech company Valneva has launched a pivotal Phase 3 trial for its investigational COVID-19 vaccine – the last step before seeking regulatory approval.
It comes as Valneva has said it will prioritize reaching deals with individual countries after failing to make “significant progress” in delivering its candidate vaccine to the European Union, dealing another blow to the block vaccination program.
Valneva’s phase 3 trial – called Cov-Compare – will compare the immune response generated by its vaccine with that of the vaccine jointly developed by AstraZeneca AZN,
and the University of Oxford, the company said in a statement Wednesday.
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The trial will examine the immune response of 4,000 participants two weeks after receiving their second dose of either vaccine, given within four weeks. It will be carried out at around 25 sites in the UK with support from the National Institute for Health Research.
The company plans to conduct additional and complementary trials as the Cov-Compare study progresses.
Valneva VLA shares,
increased by 2.59% in early European trade. The stock has risen more than 57% since the start of the year, according to FactSet.
Valneva, based in Saint-Herblain, France, is developing an inactivated whole virus vaccine, a more traditional approach to giving injections than that adopted by German biotech BioNTech BNTX,
with the American pharmaceutical company Pfizer PFE,
Valneva will use an adjuvant – ingredients that can be added to vaccines to make them more effective – made by US biopharmaceutical company Dynavax DVAX,
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Valneva said on April 6 that it would begin large-scale efficacy trials of its two-dose vaccine candidate later that month, after initial results from a Phase 1/2 clinical trial involving 153 elderly people aged 18 to 55, having been shown to produce a “strong immune response.”
The shot was also found to be “highly immunogenic,” “more than 90% of all study participants developing significant levels of antibodies against the coronavirus spike protein. It also induces T-cell responses, which help the body repel a virus and play a role in long-lasting immunity.
Valneva plans to file for approval with UK regulators in the fall of 2021. If approved, the vaccine will be produced in Livingston, Scotland. The UK has secured up to 100 million doses of the inactivated vaccine, with the option to purchase an additional 90 million doses between 2023 and 2025. Valneva plans to deliver 60 million doses by the end of the first quarter of 2022 .
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Earlier this week, Valneva said it was “deprioritizing” centralized negotiations with the European Commission to deliver its COVID-19 across the 27-member bloc, focusing instead on bilateral “country-by-country” talks.
“We have spent a lot of time and effort trying to meet the needs of the central purchasing process of the EC. Despite our recent clinical data, we have not made significant progress, ”said Thomas Lingelbach, CEO of Valneva, in a statement.
Instead, Valneva said it would focus on “European Union member states and interested parties outside the EU” who have expressed interest.
The EU said in January that it had concluded “exploratory talks” with Valneva for the supply of up to 60 million doses of its vaccine candidate. However, he had not closed the deal.