Published: 14 April 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised the Valneva COVID-19 vaccine for use in the UK.
This follows rigorous clinical trials supported by the NIHR 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, and is the first in the world to approve the Valneva vaccine.
It is the sixth COVID-19 vaccine to be approved by the MHRA, but becomes the first, whole-virus inactivated COVID-19 to gain regulatory approval in the UK.
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 COVID-19 virus.
In late 2021, the NIHR-supported study reported positive results when generating antibodies against the disease, while 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 trial 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.
It follows the Pfizer/BioNTech, Oxford/AstraZeneca, Moderna, Janssen and Novavax vaccines to be approved for use by the MHRA.
Professor Adam Finn, Chief Investigator of the Cov-Compare study, University of Bristol said:
“This is a huge, positive step forward for the Valneva vaccine and all the staff and volunteers who have been involved in the study over the past year throughout every phase of the study. Their efforts should not go unnoticed. Not only is this the first, whole-virus inactivated COVID-19 vaccine approved in the UK, but it is the first stringent regulatory authorisation of a COVID-19 vaccine based on comparative immunogenicity data, rather than clinical efficacy.
“We were extremely encouraged by the initial study data and still believe this more traditional vaccine technology can help play a key role in vaccinations globally and prevent further infections.”
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 today's 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 6th 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."
Thomas Lingelbach, Chief Executive Officer of Valneva, said:
“We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence. VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this authorization could pave the way for the availability of an alternative vaccine solution for the UK population.
“We continue to receive messages every day from people who are looking for a more traditional vaccine approach. We believe that this new approval could also lead to additional marketing authorizations in other regions of the world. I would like to personally thank all the people who have been supporting us in this endeavour and our internal teams for all their hard work.”