Findings of a study delivered in Southampton have contributed to the approval of the Valneva COVID-19 vaccine in the UK.
Over 100 volunteers took part in the clinical trial, which was supported by University Hospital Southampton and took place at various sites in the city. These included the Hampshire Research Hub and the NIHR Southampton Clinical Research Facility (CRF).
It is the sixth COVID-19 vaccine to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the first whole-virus inactivated COVID-19 vaccine to gain regulatory approval in the UK.
World-first approval
The decision to approve follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA.
The UK’s independent medicines regulator concluded the vaccine met its strict standards of safety, quality and effectiveness. It is the first in the world to approve the Valneva vaccine.
This type of vaccine (similar to the production of flu and polio vaccines), sees the virus grown in a lab and then made completely inactive. This is done so it cannot infect cells or replicate in the body but can still trigger an immune response to the virus.
UK clinical trial
In late 2021, the NIHR-supported study reported positive results when generating antibodies against the disease. The Delta variant was in circulation during the trial.
A total of 4,035 participants were recruited across the UK between April and June 2021, with over 20 NIHR-supported sites contributing to the study.
All participants received either two active doses of the Valneva vaccine, or the AstraZeneca vaccine used as a comparison dose.
‘Huge thank you’
The announcement follows the approvals of the Pfizer/BioNTech, Oxford/AstraZeneca, Moderna, Janssen and Novavax vaccines for use by the MHRA.
Professor Saul Faust, Director of the NIHR Southampton Clinical Research Facility and local investigator for the study, said:
“A huge thank you to our participants and all the research teams in Southampton who helped deliver the Valneva COVID-19 vaccine study at sites across the city.
“It is excellent that the findings of this study have contributed towards another vaccine being approved for use in the UK by the MHRA.”
Going global
Professor Andrew Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said:
“We are very pleased to see the announcement from the MHRA regarding UK approval of the Valneva COVID-19 vaccine, and would like to highlight the hard work, patience and selflessness of the research staff and participants on the study across sites across England and Scotland.
"As the sixth vaccine approved in the UK, and the third vaccine approved which was trialled in the UK, the Valneva vaccine adds another string in our bow when it comes to the global vaccination effort."
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