Valneva to start final tests on Alternative COVID-19 Vaccine
Valneva is set to launch a phase-three trial of COVID–19 vaccine this month, after getting positive results for its early-stage clinical trials.
The French drugmaker tested its vaccine in 153 adults with three dose levels based on a schedule of two doses with vaccinations three weeks apart.
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.
“The vaccine was generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board.
“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.
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 added that 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.
Kamila/Reuters