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Valneva's COVID-19 Vaccine Granted UK Regulatory Approval

A COVID-19 vaccine developed by Valneva has been granted regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).

It said it was the first independent regulator in the world to approve the vaccine.

The VLA2001 Valneva jab becomes the sixth COVID-19 vaccine to be given MHRA authorisation, and the first whole virus, inactivated, adjuvanted COVID vaccine to gain regulatory approval in the UK, the MHRA said in a statement.

A 'Positive Risk Balance'

MHRA Chief Executive, Dr June Raine, said the decision to grant approval followed "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".

Prof Sir Munir Pirmohamed, the Commission's chair, said it had "considered the available evidence" and was "pleased to say that we have advised that the benefit risk balance is positive".

The vaccine was developed by French biotech firm Valneva, which has a factory in West Lothian.

Prof Eleanor Riley, professor of Immunology and Infectious Disease, University of Edinburgh, said: "One particular advantage of the Valneva vaccine is that it is made up of the whole SARS-CoV-2 virus, not just the spike protein. This means that it will induce antibodies and T cell cells against many different components of the virus, including components that are much less susceptible to variation than the spike protein. It is possible, therefore, that this vaccine may provide better protection against new variants as they arise.  

"Approval of this vaccine by the MHRA may not make an immediate difference to vaccination programmes in the UK, but may ease the path for approval of the vaccine in countries that are still in desperate need."

Contract Dispute

In November last year, the UK Government terminated a contract for around 100 million doses of the vaccine on the grounds of a breach of supply obligations, a suggestion that the company strenuously denied.

The cancellation prompted the former chair of the country's vaccine taskforce, Dame Kate Bingham, to say that the Government might have "acted in bad faith".

The MHRA has previously given regulatory go-ahead to COVID vaccines AstraZeneca/Oxford, Pfizer/BioNTech, JanssenNovavax, and Spikevax (also known as Moderna).

The Valneva vaccine is approved for use in adults aged 18 to 50, but it's suitability for use in children and adolescents under 18, and in the paediatric population, has not yet been established. There is also limited data for use during pregnancy, the MHRA said in a summary document.

The vaccine can be stored at fridge temperatures between 2- and 8-degrees C. It is administered intramuscularly as a course of two doses (0.5 mL each) at least 28 days apart.

Prof Adam Finn, professor of Paediatrics, University of Bristol, and chief investigator of the Valneva vaccine clinical development programme in the UK, said: "This is an important step forward in several ways.  It is the first stringent regulatory authority (MHRA/EMA/MHRA) for this vaccine, thus a critical milestone towards WHO emergency use authorisation.

"It is also the first approval of a COVID19 vaccine based on immunogenicity (compared to an already-authorised vaccine), thus a pointer towards approval of future novel and reformulated vaccines."

On March 1, 2022, Valneva announced that the National Health Regulatory Authority of the Kingdom of Bahrain had granted emergency use authorisation. An approval submission has been lodged with the European Medicines Agency.

Spikevax Approval for Children

The MHRA also announced today that it approved an update to the current UK approval of the Spikevax COVID vaccine. The move will allow the vaccine to be given to children aged 6 to 11 in England, Scotland, and Wales.

Dr Raine said: "It is for the Joint Committee on Vaccination and Immunisation to advise in due course on whether 6 to 11s should be offered vaccination with the COVID-19 vaccine made by Moderna as part of the deployment programme."

Spikevax was authorised in children aged 6 to 11 in Northern Ireland under an update granted by the European Medicines Agency on March 2.

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