French biotech company Valneva has launched a key phase 3 test for its experimental COVID-19 vaccine – the last step before seeking regulatory approval.
Valneva said it will prioritize securing transactions with individual countries after failing to make “meaningful progress” in providing its vaccine candidate to the European Union, dealing another blow to the European Union. Block’s vaccination program.
and Oxford University, the company said in a statement Wednesday.
The trial will look at the immune response of 4,000 participants two weeks after a second dose of either vaccine, administered over a four-week period. It will be conducted at approximately 25 locations in the UK with the support of the National Institutes of Health Research.
The company plans to conduct additional and additional tests while the Cov-Compare study is ongoing.
Stocks in Valneva
up 2.59% in early European trading. Shares have risen more than 57% this year, according to FactSet.
The French company Valneva based in Saint-Herblain is developing a full, inactivated vaccine, a more traditional approach to vaccination than the one implemented by BioNTech’s biotechnology. Virtue
with US pharmaceutical company Pfizer
Valneva will use adjuvants – ingredients that can be added to vaccines to make them more effective – made by the US biopharmaceutical Dynavax.
Valneva said on April 6 that it will begin large-scale efficacy trials on its two-dose vaccine candidate later that month, after getting initial results from a Phase 1/2 clinical trial Involving 153 people aged 18-55, suggests it produces one “Strong immune response.”
The injection was also found to be “highly immunogenic,” with “more than 90% of all study participants developing significant levels of antibodies to the coronavirus mutant protein. It also induces T-cell responses, helps the body fight off the virus and plays a role in long-term immunity.
Valneva is expected to apply for approval with UK regulators in the fall of 2021. If approved, the vaccine will be made in Livingston, Scotland. UK has guaranteed 100 million doses inactivated vaccine, with the option to purchase an additional 90 million doses between 2023 and 2025. Valneva is expected to deliver 60 million doses by the end of the first quarter of 2022.
Earlier this week, Valneva said it was Center “deprivation”Ized negotiated with the European Commission to provide COVID-19 firing to the 27-member bloc, focusing instead on bilateral discussions on a “country-by-country basis”.
“We have committed considerable time and effort trying to meet the needs of the EC central procurement process. Despite our recent clinical data, we have not made meaningful progress, ”Valneva CEO Thomas Lingelbach said in a statement.
Instead, Valneva said it will focus on “EU member states and interested parties outside the EU” expressing interest.
The EU said in January that it was concluded “conversation of discovery” with Valneva to deliver up to 60 million doses of its candidate vaccine. However, it did not complete the deal.