London, Feb 13 | The University of Oxford has launched the first study to assess the safety and immune responses of its Covid-19 vaccine in children and young adults with first vaccinations expected during this month.
This trial will assess if children and young adults aged 6-17 years develop a good immune response with the ChAdOx1 nCoV-19 vaccine.
“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, Professor, and Chief Investigator on the Oxford vaccine trial, said in a statement.
“These new trials will extend our understanding of control of SARS-CoV2 to younger age groups.”
The study builds on previous trials of the vaccine, which have shown that it is safe, produces strong immune system responses and has high efficacy in adults.
This new trial, a single-blind, randomised phase II trial, will involve 300 volunteers, with up to 240 of these volunteers receiving the ChAdOx1 nCoV-19 vaccine, the University of Oxford said on Friday.
The remainder will receive a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as a sore arm.
“The Covid-19 pandemic has had a profound negative impact on the education, social development and emotional well-being of children and adolescents, beyond illness and rare severe disease presentations,” said Rinn Song, Paediatrician and Clinician-Scientist, Oxford Vaccine Group.
“It is therefore important to collect data on the safety and the immune response to our coronavirus vaccine in these age groups, so that they could potentially benefit from inclusion in vaccination programs in the near future.”
The trial is funded by the UK’s National Institute for Health Research (NIHR) and drugmaker AstraZeneca.
AstraZeneca’s Covid-19 vaccine, developed jointly with the University of Oxford, has been approved for emergency use in several countries. A version of the vaccine is also being used in India.
While the vaccine remains effective against the original virus and at least one variant, first discovered in Kent, England, preliminary findings in a small-scale trial prompted South Africa to limit its use while it ascertains its efficacy against the variant that emerged there.
AstraZeneca had said it could take between six to nine months to produce Covid-19 vaccines that are effective against new variants of the virus.