A Covid vaccine that was abandoned by the government because of production delays on Thursday became the sixth to be approved for use in the UK.
The Valneva jab is made in Scotland and has been found in trials to potentially offer better immunity and fewer side effects than the commonly used AstraZeneca vaccine, including against Omicron and new variants.
However there appears little chance that the Valneva vaccine, known as VLA2001, will be made available any time soon on the NHS in England - despite the UK government having helped to fund its development.
However the firm said it was in discussions with the Scottish government to offer 25,000 doses to NHS staff and frontline workers north of the border.
The decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to grant it regulatory approval provides part of the legal authority required for its use in the UK, including potentially as a booster.
Thomas Lingelbach, chief executive of Valneva, said on Thursday: “We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence.
“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. We believe that this new approval could also lead to additional marketing authorizations in other regions of the world.”
The MHRA regulatory approval follows UK trials of the vaccine in about 4,000 volunteers. Approval from the Joint Committee on Vaccination and Immunisation (JCVI) woudl also be required before ministers approved any NHS roll-out.
But the UK government currently has no contract to buy any doses, after screapping a 100m dose deal last September, and is understood to have sufficient supplies of other vaccines to meet current demand, both for first, second and booster doses.
In addition, the Valneva jab can only be given to unvaccinated adults aged 18 to 50 – of which only about five per cent have yet to receive a single jab.
A Department of Health and Social Care spokesman said: “The independent medicines regulator has approved Valneva’s Covid vaccine for use in adults aged 18 to 50 after it met robust standards of safety.
“This is the third vaccine approved by regulators in which the clinical trials took place in the UK - showcasing the strength of our incredible research sector.
“The UK continues to have sufficient supply for its vaccination programme.”
Because it only needs to be stored in a conventional fridge, the jab could also help countries who are struggling for vaccine supplies.
Valneva, a French-based firm, already has contracts to supply 60m doses to the European Union and to Bahrain.
The Valneva jab is the only Covid vaccine in Europe to use the “traditional” approach of using an inactivated whole Covid virus – which is grown in a lab and “killed” before use to prevent it replicating or causing disease - to spark immunity.
The same process has been widely used for 60 years, for example in the production of flu and polio vaccines, and has the potential to offer wider immunity.
This contrasts with the viral vector and mRNA vaccines developed by AstraZeneca, Pfizer and Moderna that deliver genetic instructions to the body’s cells to produce spike proteins.
These were quicker to produce because they used just a small part of the virus to “train” the body to respond.
Trial results also suggested that Valneva could offer longer-lasting protection against Covid, including cellular immunity in addition to that provided by antibodies.
After the UK government cancelled a deal for 100m doses last September, MrLingelbach accused ministers of throwing it “under the bus”.
He said a six-month delay in expanding its factory in Livingston was due to Brexit-related problems with the supply of materials.
However the Scottish government continued to support the factory, with £20m from an enterprise quango and a visit last month from First Minister Nicola Sturgeon.
The MHRA is the first medicines regulator in the world to approve Valneva, which is given as two jabs at least a month apart. It is licensed for adults aged 18 to 50.
It has not been licensed for use in children or in older adults because of a lack of trial data. Nor is there data on using it after a dose of another vaccine, meaning two doses of Valneva are needed to ensure protection.
Dr June Raine, MHRA chief executive, 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.”
Professor Adam Finn, a paediatrician at Bristol university who was the chief investigator in the Valneva trial, said the MHRA ruling was a “step forward”. He said if the European Medicines Agency also granted approval then it may soon become available in the EU for people yet to have a jab.
In addition, EMA approval would also make it easier for the 4,000 Britons who took part in the trial to travel abroad, he said.
A step forward for this vaccine altho UK plans to purchase it were dropped last Sept. If EMA approve it - hoped for soon - it may become available in the EU soon for people hitherto unvaccinated. EMA approval may also help trial subjects wishing to travel https://t.co/6Q3gR2TcUn
— Adam Finn (@adamhfinn) April 14, 2022
Professor Finn told the Evening Standard: “There are no plans to make it available in UK at present, as far as I know.
“If EMA approve which, it is hoped, may happen very soon, then I think there are EU orders for a large number of doses. So we may see the vaccine used in the EU soon.”
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said: “We have advised that the benefit risk balance is positive.
“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.
“The storage temperature for the Valneva vaccine - of 2°C to 8°C - is similar to that of a domestic fridge, making it appropriate for use in countries where storage at very low temperatures is not possible.”
