The Valneva Covid vaccine has been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK, making it the sixth Covid vaccine the regulator has authorised.
The MHRA is the first regulator in the world to approve the Valneva vaccine after it made the move on 14 April, and it is the first whole-virus inactivated Covid vaccine to be approved in the UK.
This means the virus is grown in a lab but is then made fully inactive, so it will bring on an immune response to the virus without infecting cells or replicating in the body.
The vaccine, developed by French biotech company Valneva and manufactured in Scotland, is approved for use in people aged 18 to 50, with first and second doses at least 28 days apart.
It should be stored at 2°C to 8°C, which is similar to the temperature of a domestic fridge, with the Government commenting that this makes the vaccine ‘appropriate for use in countries where storage at very low temperatures is not possible’.
The UK Government had previously ordered 100 million doses of the Valneva vaccine. However, the company announced in September last year that the order had been cancelled.
But today the company’s CEO Thomas Lingelbach said: ‘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.’
MHRA chief executive Dr June Raine 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.’
Chair of the independent Commission on Human Medicines Professor Sir Munir Pirmohamed said: ‘The independent Commission on Human Medicines and its Covid-19 Expert Working Group has carefully considered the available evidence and are pleased to say that we have advised that the benefit risk balance is positive.’
He added that people will ‘need to be made aware that protection will only start after two doses’.
Last month, the NHS launched the next phase of its Covid vaccination programme for people eligible for a spring booster jab.
A version of this article was originally published on The Pharmacist's sister publication Pulse.
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