THE final data on the Novavax coronavirus vaccine has been submitted to the UK regulator for approval.

The Fujifilm Diosynth plant in Billingham, near Stockton, has been earmarked to make the vaccine.

Earlier in the year, it was announced 60 million doses of the vaccine are to be made at Fujifilm in Billingham.

The approval announcement followed a meeting with Novavax’s Head of Government Affairs and Stockton North MP Alex Cunningham yesterday.

Read more: Fears for workers at Fujifilm in Billingham over Novavax vaccine delay

Mr Cunningham said: "After speaking to Novavax representatives yesterday about the need to end the uncertainty around the vaccine it’s great to hear that the company have finally submitted it for approval. I don’t know how long the approvals process will take but hope production will get up and running soon.

“This announcement is good for Billingham – creating jobs for the area – and also good for our continuing efforts to protect people against coronavirus. We now need it approved, produced and ready to be administered to people as soon as practically possible – and I‘ll continue to monitor Novavax’s progress.”

The firm behind the vaccine said it anticipates a “positive decision” following the completion of its rolling regulatory submission to the Medicines and Healthcare products Regulatory Agency (MHRA).

Tees Valley Mayor Ben Houchen, said: “The news that the Novavax vaccine has been submitted to the UK regulator for approval is a huge step forward.

“Since the start of the coronavirus pandemic Teesside, Darlington and Hartlepool have been at the forefront of the fight against the deadly virus. Our researchers and engineers at CPI have worked with the Vaccine Taskforce, scientists from Absolute Antibodies have worked on virus testing and all 60m doses of the Novavax vaccine will be manufactured right here in Billingham.

"The Novavax vaccine will be another weapon in our armoury against the Coronavirus and I’m proud it will be produced in Fujifilm Diosynth’s world-class manufacturing here and the Teesside.

“As a region Teesside, Darlington and Hartlepool have an enviable reputation the world over as a centre of excellence when it comes to engineering, chemicals and processing, but now our hugely impressive bioscience sector is getting the praise it rightly deserves.”

More than 15,000 people took part in the phase 3 Novavax trial at various hospital sites across the UK.

According to results of a phase three trial in the UK, announced in March, the jab offers 100 per cent protection against severe disease, including all hospital admission and death.

Results released in January by Novavax regarding its South Africa trial showed 60 per cent protection against mild, moderate or severe disease, where most cases were the South African variant.

Today (Wednesday), Novavax said its application for conditional marketing authorisation (CMA) marks the first submission for authorisation of a protein-based coronavirus vaccine in the UK.

Britain has ordered 60 million doses of the vaccine.

Stanley Erck, the company’s president and chief executive, said: “This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based Covid-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus.

“We look forward to MHRA’s review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision.

“We thank the clinical trial participants and trial sites in the United Kingdom, as well as the UK Vaccines Taskforce, for their support and vital contributions to this programme.”

Earlier this month, it was announced that thousands of people who took part in the trial will be able to have two further doses of another vaccine to enable them to travel abroad.

The fact the jab has not yet been approved means thousands of people have been unable to travel because other countries do not recognise Novavax as a valid Covid vaccine.

After taking advice from the Joint Committee on Vaccination and Immunisation (JCVI), the Department of Health said those in England who took part in the UK-based Novavax trial should be offered two doses of the Pfizer/BioNTech jab, with eight weeks between the doses.

Scotland, Wales and Northern Ireland’s health teams were expected to follow suit.

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