The UK’s medicines regulator on Thursday approved Valneva as a new vaccine to protect against COVID-19, the first whole-virus inactivated COVID vaccine to gain regulatory approval in the country. The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first in the world to approve the Valneva vaccine, which becomes the sixth COVID-19 vaccine to be granted an MHRA authorisation.
With this type of vaccine, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response to the COVID-19 virus. 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, said Dr June Raine, MHRA Chief Executive.
As with the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in use in the UK, Valneva is designed to be given as two doses. The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.
The process used in the Valneva vaccine is widely used already in the production of flu and polio vaccines. The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence are pleased to say that we have advised that the benefit risk balance is positive, said Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines.
Each type of vaccine has a different pattern of antibody response over time. 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, he said.
The storage temperature for the Valneva vaccine is between 2 degrees Celsius and 8 degrees Celsius, which is similar to that of a domestic fridge. The MHRA says this makes it appropriate for use in countries where storage at very low temperatures is not possible. The vaccine has been produced at the Valneva factory in Livingston near Edinburgh in Scotland. In trials, blood results from volunteers who received the jab had high levels of neutralising antibodies against the pandemic virus.
Some experts hope that it is possible that by using the whole virus, rather than just the spike protein, the new vaccine may be more useful against future emerging variants of COVID-19.