Valneva's COVID-19 shot set for Phase 3 trial this month

April 07, 2021 World
Valneva on Tuesday reported excellent results because of its COVID-19 vaccine found in early level clinical trials and said it planned to launch a Phase 3 trial this month.The French drugmaker, whose shot uses the technology behind its licensed Japanese encephalitis vaccine, tested its vaccine in 153 adults with three dose levels predicated on a schedule of two doses with vaccinations three weeks aside. Valneva shares had been up 8% in early on trading.

The vaccine, Valneva said, was "generally safe and well tolerated across all dose groups tested, with no safety concerns discovered by an unbiased Data Safety Monitoring Board".Valneva said the vaccine, that the U.S. firm Dynavax supplies an adjuvant, was also "remarkably immunogenic", with "a lot more than 90% of all study participants" developing significant degrees of antibodies to the corona virus spike protein.

"Based on the data assessed, the company has made a decision to advance the huge dose into the stage 3 clinical trial. Different trials, including booster trials, regarding antigen sparing doses may also be evaluated," Valneva explained.The business added that it was working with authorities in Britain to examine plans including for potential variant vaccine advancement and supply.

Valneva has signed a good deal with Britain for 190 million dosages by 2025 in a good transaction potentially worth up to 1 1.4 billion euros ($1.65 billion). The business can be in talks with the European Union to supply it with 60 million doses.The company said it designed to submit the vaccine for approval in Britain in the autumn of this year and said discussions with other regulatory bodies were ongoing.