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Minister said to ban EU from UK trial data in vaccine row | Vaccines and Immunizations

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Britain’s deputy director may reveal that he has asked ministers to withhold data from all UK clinical trials in the EU if European countries continue to deny entry to UK vaccine trial applicants.

Jonathan Van-Tam made a special offer after months of uncertainty for the 19,000 volunteers who could not effectively travel to Europe where they could not see their families, work or go on vacation because they took part in the Novavax and Valneva exams.

Those vaccinated during the trial will face catch-22 because neither treatment has yet been approved by health regulatory agencies. They’ve been vaccinated twice, so they can’t get any other vaccines through the NHS. However, since no trial vaccine has been licensed, it is not possible to prove vaccination outside the UK, requiring quarantine in many countries.

If you were vaccinated with Pfizer, AstraZeneca or Moderna, you could have traveled using your vaccine passport through the NHS app or other documentation.

Professor Van-Tam revealed that he made the proposal in a conversation with a Novavax volunteer at the awards ceremony on September 1.

Ffyona Dawber, who runs a medical communications agency and is also a guest at the event, approached Van-Tam at a table at the Grosvenor House hotel in central London.

He was very compliant, Dawber said. As soon as I said I was testing Novavax, he put his head in his hands and said, My God, that’s a disaster. He asked sympathetic questions about her situation, Dawber said.

I know you can’t influence international borders and he said no, no, no. He said that our clinical trial subjects were vaccinated in their own country. He added that the offer was rejected. The government did not dispute her explanation of the conversation.

Professor Jonathan Van-Tam speaking at the April 2021 media briefing. Photo: Kirsty Wigglesworth/PA

Withholding clinical trial data would be unprecedented, and the proposals indicate just how strongly Van-Tam feels about the matter. In June, he wrote an open letter promising test applicants that they would not be penalized when global travel resumes.

He is well aware that this will have a huge negative impact on people doing clinical trials in the UK in the future, Dawber said.

It is understood that the ministers were talking with their European counterparts about recognizing an investigational vaccine. An alternative solution is for test volunteers to receive an approved NHS vaccine.

Last week, Dawber and hundreds of other volunteers formed a group of interested participants in Novavax UK and wrote a letter to Health Minister Sajid Javid asking them to ensure that they receive an approved vaccine.

Dawber has not been able to travel to the Netherlands to visit her Dutch husband’s family since the outbreak of the pandemic, and is concerned about working abroad with a consulting firm that trains doctors on new treatments and surgical methods.

We got a job in France in December, and I probably won’t be able to do it, Dawber said. So if this isn’t sorted out, it will start to affect your business as well.

We are here to help. And now we don’t have a licensed vaccine. It just seems crazy.

Some of the group with families abroad hopelessly lied to NHS clinics about their vaccine status.

A Scottish volunteer with a family in the Czech Republic went to the clinic but was rejected for taking part in a clinical trial.

I decided to go to the drop-in center and lie, she said. All I had to do was get vaccinated and see my family. It felt very bad to do it, but I had no choice. In June, I was told that another study was being recruited. You will be crazy to do it. Everyone thinks you get paid, but you don’t.

Another volunteer, Gillian Ince, retired early as head of learning and development at a large American company and is taking a vacation in January next year.

She said she actually felt trapped in her own country. I feel a bloody prisoner. I feel like I’m in the most terrible situation of my life because I can’t do anything.

I have sleepless nights and I am very anxious. Everyone who took the Phase 3 trial, like me, was disillusioned. We remain in the dark. You feel completely messed up. It’s hard to explain how disappointed I was.

Approval for the Novavax vaccine was expected earlier this year, but is now not expected for at least two months, resulting in some of the 15,000 trial applicants dropping out. Last week, the UK government said it would not proceed with the planned purchase of 100 million doses of Balnevas vaccine. The company said it will continue to seek approval from pharmaceutical and health care product regulatory agencies.

Because the vaccine is being tested in a double-blind clinical trial, no one knew if they had received the COVID-19 vaccine or received any other treatment, so those more vulnerable to the virus could not be reassured.

“Clinical trials of a COVID-19 vaccine have played an important role in ensuring we have a safe and approved vaccine,” a government spokesperson said.

We make it clear that volunteers for an officially approved Covid-19 vaccine trial in the UK should not be penalized with respect to their vaccine certification policy, and that We are doing our best to take action.

Sources

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2/ https://www.theguardian.com/society/2021/sep/18/ministers-told-bar-eu-uk-trial-data-vaccines-row-england-deputy-chief-medical-guinea-pigs

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