THE Covid vaccine which is set to be made in the North East is facing “significant” delays and may not be approved until next year at the earliest, The Northern Echo understands.

The Novavax vaccine, which if successful would be made at Fujifilm Diosynth in Billingham near Stockton, is yet to be submitted to UK regulators for the go-ahead.

It comes as the Oxford/AstraZeneca and Pfizer/BioNTech vaccines saw approval after just several weeks of passing the third and final stage of clinical trials in the UK.

The medicines regulator has denied to comment, while Novavax has admitted that timings have shifted from original plans and is hoping to submit findings for approval within the next few months.

The Northern Echo:

An email seen by The Echo between participants and the North Tees and Hartlepool NHS Trust, which has been running clinical trials for the Novavax jab, last night suggested a date for the vaccine to be ready was now unknown.

'We are now five months beyond that'

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.”

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."

The Northern Echo:

In the email from the ‘Novavax Study Team’ at the Teesside trust, they told participants that tests were now being completed on the manufactured product and results were being collated for the final submission. 

The email said: "The final items needed for all global filings were the validation of analytic assays – specifically potency and purity.

"After input from the MHRA/EMA/FDA these have now been validated. NVX are now running the assays on the manufactured product and writing up the results for the final manufacturing submission.

"The filings will now happen at a similar time in EU and UK (and other countries too) but NVX now does not expect to complete regulatory filing in the third quarter of 2021.

"It is anticipated this will take an additional couple of months. The length of time required to adjudicate/approve the file is of course, unknown and will vary by regulatory agency."

It went on to say that a booster vaccine could not now be offered as part of the third phase of trials stating that it received notification from UK regulators to say a booster study should not be added to current trials.

Last month, Novavax confirmed it had delayed its plans to seek approval with the Food and Drug Administration in the US.

At the time, Stanley Erck, chief executive of Novavax, blamed the delay on the “time-consuming” process in getting its manufacturing, analytics of potency and purity tests “in line.”

'Working as quickly as possible'

In response, Novavax said timings had "shifted" from what it had "originally guided," and that it expected final filings to US regulators - including UK regulators - would occur in the next couple of 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 Department of Health has been approached for comment, while the Medicines and Healthcare products Regulatory Agency has declined to comment.


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