THE Government has responded after it emerged the North East-made vaccine, Novavax was facing significant delays and may not be ready until next year at the earliest.

The Northern Echo revealed how the Novavax vaccine, which if successful would be made by Fujifilm Diosynth in Billingham, is yet to be submitted to UK regulators for approval.

It came as participants in a North East trial said they had been “abandoned,” after being told guidance is yet to be published on whether it is safe to have an alternative jab.

EXCLUSIVE: North East made Covid vaccine is facing delays - and may not be ready until 'NEXT YEAR'

Those who have been involved in a trial at the University Hospital of Hartlepool for the past twelve months said they now feared being left unprotected for winter as a result.

Meanwhile, they said they had been left seriously disadvantaged as they were unable to travel abroad as their jab is not recognised by other countries.

The Northern Echo:

A source close to the Novavax study said that as the third phase of trials were underway several months ago, there was a shared understanding the vaccine would be approved within “weeks," back then.

They said: “When we were having the Novavax jab, they were telling us it would be a matter of weeks, we are now five months beyond that.

"Originally it was due (approval) to be in the first part of this year, now it looks like it could be anything up to the middle of next year."

On Friday, The Echo reported that hundreds of volunteers hit out and write a joint-letter to Health Secretary Sajid Javid calling for “fair treatment” to the 15,000 participants left in limbo amid approval delays.

EXCLUSIVE: 'We've been abandoned': Those who took part in North East vaccine trial hit out

In the letter, which was signed by dozens taking part in Hartlepool, they urged him to “immediately” rectify the situation to allow Novavax volunteers become recognised and freely travel.

Meanwhile, on Saturday it was reported that England’s deputy chief medical officer, Professor Jonathan Van-Tam had suggested data from UK clinical trials is withheld from the EU, which was later refused.

The Northern Echo: It will be produced in Billingham, if successful It will be produced in Billingham, if successful

But a spokesperson for the Government said that being in a Covid vaccine trial should not disadvantage those and the government intended to “take action” to ensure this remains the case.

The Government said that the Vaccine Taskforce and Medicines and Healthcare Regulatory Agency (MHRA) is now working with Novavax to ensure approval is authorised as "quickly as possible," where possible.

A government spokesperson said: “Clinical trials of COVID-19 vaccinations have played an instrumental role in getting us to the point where we have safe, approved vaccines and they are providing critical data to help us respond to this pandemic.

“We are clear that volunteers in formally approved COVID-19 vaccine trials in the UK should not be disadvantaged in relation to vaccine certification policies, and we are committed to taking action on this issue, including reviewing guidance on additional vaccination for this group.”

The Government said clinical trial participants can now gain access to an NHS COVID Pass for domestic use.

In addition, they said that they should have a letter confirming their participation in the specific vaccine study and confirming that they have the same protected status as someone who has received the approved vaccines.

Novavax previously admitted to The Echo that timings had “shifted” and that it is hoping to submit findings for approval within the next few months, although no definitive date was given.

It said that it is now in active conversations with various regulatory bodies across the world including the Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organisation and US Foods and Drug Administration.

In a statement, it said: "Novavax is in alignment with these regulatory authorities on the final requirements to complete these submissions.

"As a result, there is additional work underway and we now expect that these final filings, including to MHRA, will occur in close proximity to each other in the next couple of months."

It said that it continued to work "as quickly as possible" in order to complete submissions to regulators in the UK.

The Medicines and Healthcare products Regulatory Agency previously declined to comment citing “commercial sensitivity.”

Are you in the North East and been affected by the Novavax trial? If so, email


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