Valneva’s Covid vaccine gets approved for use in UK… but No10 already cancelled £1.2billion contract for jabs because it would ‘never get green light’

• The UK has become first in the world to approve Valneva’s two-dose vaccine
• The regulator found the jab is safe and effective in 18 to 50-year-olds
• It comes after No10 cancelled its order for 100million doses in September 

Valneva’s Covid vaccine has become the sixth to be approved in the UK. 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the first in the world to green-light the two-dose vaccine, said it is safe and effective in 18 to 50-year-olds.

The injection is the only approved Covid jab to use an inactivated Covid virus to trigger an immune response, meaning it triggers an immune response without causing an infection.

Trials by the French drug firm showed the jab triggers a strong antibody and T-cell response as well as few side effects.

But it’s not clear if the vaccine – called VLA2001 –will be used in Britain. 

No10 had ordered 100million doses of the jab but cancelled its £1.2billion contract with Valeva in September due to a ‘breach of obligations’. The company denied the accusation. 

Health Secretary Sajid Javid later said the contract was cancelled over ‘commercial reasons’ and because the jab would not have been approved by the UK’s medicines watchdog.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the first regulator in the world to approve the jab, said it is safe and effective 

The Government cancelled its contract with Valneva for up to 190million Covid vaccines in September. Some 100million had already been ordered for delivery in 2021 and 2022 and the UK had the option of requesting an additional 90million that would be delivered between 2023 and 2025. Now the agreement has been terminated, Pfizer is the most-ordered jab in the UK, with 189million. Some 100million doses of AstraZeneca have been ordered, along with 77million Moderna vaccines. It has ordered 60million doses each of the jabs made by GSK and Novavax. Meanwhile, the Government has requested 50million CureVac vaccines and 20million Janssen injections

The biotech firm has been manufacturing its vaccine at its plant in Livingston, West Lothian, which Scotland’s First Minister Nicola Sturgeon visited last month

The jab is the first whole-virus inactivated Covid vaccine to gain regulatory approval. 

This means the virus is grown in a lab and made completely inactive so it cannot infect cells or replicate in the body. 

Instead, it triggers an immune response to the virus. This process is widely used already in the production of flu and polio vaccines. 

It is stored at temperatures between 2°C to 8°C — similar to a domestic fridge. And the first and second doses are administered at least 28 days apart.

Valneva previously said its vaccine would not be rolled out to older adults if approved because the jab was not tested on them during UK trials due to the quick rollout of first doses to the cohort. 

Dr June Raine, chief executive of the MHRA, said the approval follows a ‘rigorous review of the safety, quality and effectiveness’ of the vaccine and expert advice from the Commission on Human Medicines — the Government’s medicines advisers.  

WHAT DO VALNEVA COVID JAB TRIALS SHOW?

Is Valneva’s vaccine safe?

No safety concerns were raised during earlier clinical trials scientists said, paving the way for it to be advanced to the next stage.

The third phase found the jabs was ‘generally well tolerated’ and participants reported ‘significantly fewer’ side effects in the week after vaccination compared to the Oxford jab. 

And no serious adverse events were recorded.  

How does the vaccine work? 

The vaccine is the only one being developed in Europe to use an inactivated whole Covid virus to trigger an immune response.

When it is injected the body attacks the spike proteins on the virus – which it uses to invade cells – by making antibodies that can bind to them, stopping an infection from happening.

The virus is killed before it is injected using chemicals, heat or radiation, meaning there is no risk of it triggering an infection.

This type of vaccine is already used to protect against polio and flu.  

What was Valneva’s agreement with the UK?

The UK ordered 100million doses from the French vaccine-maker to be delivered in 2021 and 2022.

The contract also allowed the UK to order an additional 90million jabs between 2023 and 2025.

But Valneva announced in September that the Government terminated the contract, claiming the company breached its obligations.

Sir Munir Pirmohamed, chair of the commission, said his team found the jab’s ‘benefit risk balance is positive’.

He said: ‘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.’

Its storage temperature means the vaccine is  ‘appropriate for use in countries where storage at very low temperatures is not possible’, Sir Munir added.

The biotech firm has been manufacturing its vaccine at its plant in Livingston, West Lothian.

The UK had ordered 100million doses from the French vaccine-maker to be delivered in 2021 and 2022.

The contract also allowed the UK to order an additional 90million jabs between 2023 and 2025.

But Valneva announced in September that the Government terminated the contract, claiming the company breached its obligations.

Mr Javid subsequently told the Commons it would not be approved in the UK.

He said: ‘There are commercial reasons that we have cancelled the contract, but what I can tell her is that it was also clear to us that the vaccine in question that the company was developing would not get approval by the MHRA here in the UK.’ 

However, the Health Secretary later amended his comments to say the vaccine ‘has not yet gained approval’ and ‘may not’ be green-lit in Britain.

Trials by Valneva showed the jab triggers a stronger antibody response than AstraZeneca’s rival jab when trialled on thousands of Britons.

The Cov-Compare trial involved 4,012 18 to 55-year-olds across the UK who were given Covid vaccines in two doses four weeks apart. 

Around two-thirds were given the French-made injection, while the others were given AstraZeneca.

In phase three results released in October, Valneva said its vaccine ‘demonstrated superiority’ over AstraZeneca by triggering 39 per cent more neutralising antibodies.

The company said the jab induced broad T-cell responses, a part of the immune system believed to be involved in long-term immunity. 

The side effects from the injection were ‘significantly more favourable’ that the comparator vaccine, with less people reporting a sore arm and other reactions.

Around one in 10 people will suffer from side effects after the AstraZeneca jab, such as a sore arm, tiredness and headache.

The number of Covid cases were similar between those given AstraZeneca or Valneva, suggesting they were just as effective. 

And the ‘complete absence’ of any severe Covid cases in the group suggest both vaccines offer protection against currently circulating variants, the company said. 

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