Thousands to test safety of British vaccine
FOUR thousand volunteers are being recruited to test a new coronavirus vaccine.
The jab, developed by Valneva, is being manufactured at the company’s Scottish site in Livingston, West Lothian.
It is the only inactivated, adjuvanted Covid-19 vaccine – meaning it has an ingredient to create a stronger immune response – in clinical development in Europe.
Inactivated jabs have been used over the last 100 years to vaccinate billions of people – including for seasonal flu, hepatitis A, polio and rabies.
After positive safety results from the first two phases of the trial – which showed the study vaccine dose was “well tolerated with no safety concerns identified” – recruitment for the final phase of the study will start before the end of April.
The study will run across 22 National Institute for Health Research (NIHR) sites in England, and two devolved administration sites in Scotland.
It is open to healthy adults who have not had a Covid-19 vaccine yet. But unlike previous vaccine trials, those over 30 who participate will not be given a placebo and will instead receive either two doses of the
Valneva candidate, or two doses of the Oxford/AstraZeneca jab, which has already been approved.
Participants aged 18 to 29 can also be enrolled to receive the Valneva vaccine but they will not be offered the Oxford/ AstraZeneca vaccine.
If the trials are successful, Valneva aims to make submissions for approval in the autumn. It says it can provide up to 250 million vaccine doses to the UK and other countries around the world.
Role
Up to 100 million doses of the vaccine have been secured by the UK.Volunteers will be vaccinated at the beginning of May. Some will be on the NHS Covid-19Vaccine Research Registry, which has over 480,000 sign-ups.
Thomas Lingelbach, chief executive officer of Valneva, said: “The world needs multiple vaccines and we believe that ours has an important role to play – including boosters or potential modifications to address variants.”