French drug firm Valneva reports positive results from its Covid trial 

The vaccine produced a stronger antibody response than AstraZeneca‘s rival jab when trialed 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 canceled 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’.

And he said Valneva is ‘cautiously optimistic’ the vaccine will be approved in the UK by the end of the year, and it is not clear why Mr Javid said it would not be.

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

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

The graph shows the antibody levels — known scientifically as the geometric mean titre (GMT) — triggered by Valneva’s vaccine (left), compared to AstraZeneca’s jab (right) on day one (dark blue bar) and two weeks after the second dose is administered (light blue bar). Trials of 4,012 Britons found the French-made vaccine on average produced 39 per cent more antibodies among those who received it than those injected with AstraZeneca

Professor Adam Finn, trial chief investigator said the results suggest Valneva’s jab ‘is on track to play an important role in overcoming the pandemic’

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.

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 39 per cent 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.

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.

Professor Finn said it was ‘ethically impossible’ to measure the vaccine’s efficacy because other vaccines were already being rolled out rapidly in the UK.

Instead, under an approach agreed with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the jab was tested by comparing it to a vaccine that had already been approved.

For Valneva’s jab to be licensed, its vaccine has to trigger a higher immune response than AstraZeneca’s jab.

This approach is already used to license new meningitis vaccines, Professor Finn 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 vaccinating people who are reluctant to receive Covid jabs using ‘newer vaccine platforms’ is a priority, so there is a role for Valneva’s jab in countries that are advanced in the rollout, as well as countries struggling with dishing out injections.

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 here in the UK’.

But Professor Finn said: ‘We don’t really know why he said that.’ Mr Javid subsequently corrected his comments and acknowledged he ‘got it wrong’, he said.

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

The Government cancelled its contract with Valneva for up to 190million Covid vaccines last month. 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 135million due to arrive in Britain by next year. Some 100million doses of AstraZeneca have been ordered, along with 60million doses each of the jabs made by GSK and Novavax. Meanwhile, the Government has requested 50million CureVac vaccines, 20million Janssen and 17million Moderna injections

He added: ‘The data presented today is as good as we could have hoped for in the strategy toward authorisation that the MHRA set out.

‘So we are cautiously optimistic we will get authorisation based on this data.’

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.

Professor Finn said ‘we are all drifting into position we are talking like pandemic done and dusted’, but there are uncertainties about how the virus will evolve, how the vaccines will perform over time and global supply.

‘So having a wider range of vaccines puts us in a more secure position everywhere,’ he said.

‘We need more vaccines, more platforms and we need to give ourselves options to cover ourselves against things we don’t know that are going to happen in the future.’

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 and will approach other countries, including the US, in the first half of next year.

If the jab is approved, it will only be authorised for 18 to 55-year-olds due to difficulties recruiting older groups during the UK participants due to the quick rollout of first doses to older groups earlier this year.

The company is now trialling the injection 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.

These results will then be given to regulatory authorities, so the vaccine could subsequently be approved for younger and older groups.