French drug firm Valneva reports positive results from its Covid trial

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French drug firm Valneva today reported successful results from its Covid vaccine trial — a month after the UK cancelled its contract for 100million doses.

The vaccine produced a stronger antibody response than AstraZeneca’s rival jab when trialled on thousands of Britons, the company said.

It also induced a strong T-cell response and triggered few side effects. No serious cases of Covid were spotted among recipients given the jab.

Ministers last month pulled out of its £1.2billion deal for 190m doses of the vaccine citing a ‘breach of obligations’. Valneva ‘strenuously’ 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.

But Professor Adam Finn, trial chief investigator and member of the Joint Committee on Vaccination and Immunisation, which advises No10 on the vaccine rollout, said the results suggest the jab ‘is on track to play an important role in overcoming the pandemic’.

The biotech firm has been manufacturing the vaccine at its plant in Livingston, West Lothian, which Boris Johnson visited in January.

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WHAT DO VALNEVA COVID JAB TRIALS SHOW?

Valneva has reported the phase one, two and three clinical trial results for its coronavirus vaccine.

The most recent trial involved 4,012 British volunteers who received two doses of the Valneva or AstraZeneca vaccine two weeks apart.  

Participants were asked to report any side-effects, and had their blood tested for Covid antibodies two weeks after getting their second dose.

Does the jab trigger Covid-fighting antibodies? 

Results showed everyone who received a high dose of the jab had Covid antibodies in their blood stream.

The company said the vaccine ‘demonstrated superiority’ over the AstraZeneca vaccine.

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 is the next stage for the vaccine? 

The company is in the process of asking the UK and European Union to approve its vaccine. 

The injection was also one of the seven Covid vaccines included in the Cov-Boost trial.

The study, led by researchers at University Hospital Southampton NHS Foundation Trust, aims to determine which jab is the most effective for booster doses.

Valneva’s is also trialling its jabs on older adults in New Zealand and preparing to test it on five to 12-year-olds.

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.

The Cov-Compare trial involved 4,012 adults 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. 

Blood samples were taken from participants two weeks after their second jab. 

In phase three results released today, Valneva said its vaccine – called VLA2001 – ‘demonstrated superiority’ over AstraZeneca by triggering more neutralising antibodies.

The company said its vaccine 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. 

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. 

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. 

Professor Finn said: ‘The low levels of reactogenicity and high functional antibody responses alongside broad T-cell responses seen with this adjuvanted inactivated whole virus vaccine are both impressive and extremely encouraging.

‘This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic.’

Thomas Lingelbach, chief executive officer of Valneva, said: ‘These results confirm the advantages often associated with inactivated whole virus vaccines.

‘We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the Covid pandemic.

‘We are keen to propose an alternative vaccine solution for people who have not yet been vaccinated.’ 

It comes after Mr Javid said it was ‘clear to use that the vaccine in question that the company was developing would not get approval by the MHRA [Medicines and Healthcare products Regulatory Agency] here in the UK’.

Some 100million doses of the vaccine were put on order after the UK increased its request by 40million back in February. 

The Government had the option of ordering an additional 90million doses to be supplied between 2023 and 2025. 

Valneva said today it has submitted its vaccine for approval by the (MHRA) and its decision will depend on the outcome of a final clinical study report.

The company said it is also preparing to ask the European Medicines Agency to approve its jab. 

Valneva’s jab is now being trialled on 306 volunteers aged 56 and over in New Zealand.

The vaccine maker is also preparing to trial its jab in youngsters aged five to 12 and as a booster jab.

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