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

PARIS (Reuters) -Valneva on Tuesday reported positive results for its COVID-19 vaccine in early stage clinical trials and said it planned to launch a Phase Three 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 based on a schedule of two doses with vaccinations three weeks apart.

Valneva shares were up 8% in early trading.

The vaccine, Valneva said, was “generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board”.

Valneva said the vaccine, for which the U.S. company Dynavax supplies an adjuvant, was also “highly immunogenic”, with “more than 90% of all study participants” developing significant levels of antibodies to the coronavirus spike protein.

“Based on the data assessed, the company has decided to advance the high dose into the phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated,” Valneva said.

The company added that it was working with authorities in Britain to review plans including for potential variant vaccine development and supply.

Valneva has signed a deal with Britain for up to 190 million doses by 2025 in a transaction potentially worth up to 1.4 billion euros ($1.65 billion). The company is also in talks with the European Union to supply it with 60 million doses.

The company said it intended to submit the vaccine for approval in Britain in the autumn of this year and said discussions with other regulatory bodies were ongoing.

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