The UK is the first country in the world to approve the Valneva vaccine, which is the sixth COVID-19 vaccine to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
The vaccine, of which the UK government has ordered 100 million doses, was approved on 14 April 2022 for use in people aged 18–50 years, with the first and second doses to be taken at least 28 days apart.
It is a whole-virus vaccine, which contains an inactivated form of the SARS-CoV-2 virus that cannot infect cells or replicate in the body, but can still trigger an immune response to the virus.
The same technology is used to produce flu and polio vaccines, but Valneva is the only company in the UK government’s vaccine portfolio that has based its COVID-19 vaccine development on this approach.
June Raine, chief executive of the MHRA, said: “Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”
Munir Pirmohamed, chair of the independent Commission on Human Medicines, said that the group had “carefully considered” the available evidence and advised that the benefit-risk balance for the vaccine was “positive”.
“Each type of vaccine has a different pattern of antibody response over time,” he added.
“For the Valneva vaccine, two doses are required before a robust antibody response is raised. This means that people will need to be made aware that protection will only start after two doses.”
According to Pirmohamed, the storage temperature for the Valneva vaccine (2°C to 8°C) is similar to that of a domestic fridge, making it appropriate for use in countries where storage at very low temperatures is not possible.
Valneva’s vaccine manufacturing site is based in Livingston, near Edinburgh, and has received investment from the UK government to support its scale-up into a major UK vaccine facility.