Ministers are called to prevent the European Union from data on British experiments in the vaccine issue | Vaccines and immunization

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England’s deputy chief medical officer has asked ministers to withhold all UK clinical trial data from the European Union if European countries continue to refuse entry to British volunteers for a vaccine trial, the Observer revealed.

Jonathan Van Tam made the extraordinary proposal after months of uncertainty for 19,000 volunteers who are virtually unable to travel to Europe to see family, work or go on vacation because they participated in the Novavax and Valneva trials.

Since no treatment has been approved by medical regulators, people who received vaccines during trials face a problem. They have had two doses, so they are not allowed other vaccines through the NHS. But because their experimental vaccines were unlicensed, they cannot prove vaccination status outside the UK, which means many countries require them to quarantine.

If they received the Pfizer, AstraZeneca or Moderna vaccines, they would be able to travel with vaccine passports via the NHS app or other documents.

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

Ffyona Dawber, who runs a medical communications agency and was also a guest at the party, approached Van-Tam at his table at the Grosvenor House Hotel in central London.

“It was very nice,” Dopper said. “As soon as I said, ‘I’m at Novavax’s trial,’ he put his head in his hands and went, ‘Oh my God, this is a disaster.'” Dober said he asked her sympathetic questions about her situation.

“I said, ‘I realize you can’t influence international borders’ and he said ‘No, no, no’ – he said he had suggested the government should withhold all future clinical trial data from the EU if the EU didn’t allow our clinical trial people who were done with it.” vaccinate them in their countries. She added that the proposal was rejected. The government did not dispute its version of the conversation.

Professor Jonathan Van Tam speaks during a briefing in April 2021. Photo: Kirsty Wigglesworth/PA

The withholding of clinical trial data would be unprecedented and the proposal indicates how strongly Van-Tam feels about this problem. In June, he wrote an open letter promising pilot volunteers they would “not be disadvantaged as global travel resumes.”

“He is fully aware that this will have a significant negative impact on people doing trials in the UK in the future,” Dober said.

Understandably, ministers have spoken to their counterparts in Europe about learning about experimental vaccines. An alternative solution might be for experimental volunteers to have an NHS-approved vaccine.

Last week, Dober and hundreds of other volunteers formed the Novavax UK Concerned Participants Group and wrote to Sajid Javid, the health minister, asking him to allow them to receive approved vaccines.

Dober has not been able to travel to the Netherlands to visit her Dutch husband’s family since the pandemic began, and is also concerned about working abroad with her consultant, who trains doctors in new treatments and surgical practices.

“We got a job in December in France, and I probably wouldn’t be able to do that,” Duber said. “So unless this is sorted out, it will start to affect the business as well.

“We did our best to help. Now we are not allowed to have a licensed vaccine. It just seems crazy.”

Some in the group with family abroad lied to NHS clinics about their vaccine status out of desperation.

A volunteer in Scotland, who has family in the Czech Republic, went to a clinic without an appointment but was turned away because she told them she had taken part in a trial.

“I decided to go to a reception center and lie,” she said. “That was the only thing I was thinking about getting vaccinated and seeing my family. I felt bad about doing it, but I had no other choice. In June, I heard another study was recruiting. It would be crazy to do it. Everyone assumes you get On money, but you don’t.”

Another volunteer, Jillian Ince, who retired early as the head of learning and development at a large US company, was hoping to go on vacation next January.

“I actually feel trapped in my country,” she said. I feel like a bloody prisoner. It seems like the most horrible situation I’ve ever faced in my life, because I can’t do anything.

“I suffer from sleepless nights and feel very anxious. People who have done the third phase of the experiment are like me – we are all very disappointed. We were left in the dark. You feel completely trapped. It is hard to describe how frustrated I am.”

The Novavax vaccine was expected to be approved earlier this year, but is now not expected for at least another two months, leaving some of the 15,000 volunteers involved in the trial. The British government said last week it would not go ahead with the purchase. 100 million planned doses of Valneva vaccine. The company said it would continue to seek approval from the Medicines and Healthcare products Regulatory Agency.

Because the vaccines are being tested in double-blind clinical trials, none of the participants initially knew whether they had received a Covid vaccine or a different treatment, although they later had the opportunity to cross over and receive an active vaccine.

Novavax said it was working urgently to complete its requests for approval from the Ministry of Health and Population, and was arguing on behalf of those involved in the trial.

A government spokesperson said: “Clinical trials of Covid-19 vaccines have played an instrumental role in getting us to the point where we have safe and approved vaccines and provide important data to help us respond to this pandemic.

“We are clear that volunteers in officially approved UK Covid-19 vaccine trials should not be disadvantaged in terms of vaccine adoption policies, and we are committed to taking action on this issue, including reviewing guidance on additional vaccination for this group.”

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