Valneva said its recent Covid-19 vaccine trial produced a strong immune response and will now be fast-tracked into a phase III/final-stage study.
The French company is developing the vaccine with the help of the UK government, which has already ordered 60mln doses to be manufactured at the group’s plant in Livingston, Scotland
In a statement, Valneva said that based on the results of the Phase 1/2 clinical trial of VLA2001, an inactivated, adjuvanted candidate, it would apply to start a phase III trial by the end of April
In the phase I/II study, two doses with vaccinations three weeks apart were evaluated in 153 healthy adults aged 18 to 55 years.
The vaccine was generally safe and well-tolerated across all dose groups tested, but importantly more than 90% of all study participants developed significant levels of antibodies to the SARS-CoV-2 virus spike protein.
VLA2001 also sparked broad T-cell responses that are key to help the body fight off any Covid-19 infection.
Clive Dix, chair of the UK Vaccines Taskforce, said: “These are great results from Valneva, particularly around the antibody and cellular responses generated and low numbers of adverse events, as these indicate good levels of immune responses among the participants to date.
“The findings of 100% levels of immunogenicity against the viral spike protein in the high-dose group is also encouraging.”
Thomas Lingelbach, Valneva’s chief executive, said: Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play.
“This includes potential modifications to the vaccine to address variants, using our existing manufacturing process.
“Inactivated virus vaccines are proven technologies that are often able to induce wide-ranging immune responses, and these promising data indicate that VLA2001 may continue this trend.”
Valneva added that the timeline for the delivery of 60mln doses of vaccine to the UK Government will extend into the first quarter of 2022.
Based on the Phase 1/2 data, the company is also investigating antigen sparing options for booster strategies.
Nadhim Zahawi, Britain’s vaccine deployment minister, revealed today that the deployment of Moderna’s candidate, the third vaccine in the UK’s programme, would begin in the third week of April.
The government wants to give all UK adults a first dose of a Covid-19 vaccine by the end of July, though question marks over the AstraZeneca version and the possibility of an adverse blood clot reaction among some young people might put the timetable under threat.