England’s deputy chief medical officer has asked ministers to withhold all UK clinical trial data from the EU if European countries continue to deny entry to British volunteers in vaccine trials, the Observer can reveal.
Jonathan Van-Tam made this extraordinary proposal after months of uncertainty for the 19,000 volunteers who effectively cannot travel to Europe to see family, work or go on vacation because they participated in the Novavax and Valneva trials. .
Since none of the treatments have yet been approved by medical regulatory bodies, people who received vaccines during trials face failure. They have received two doses, so they are not allowed to receive further vaccines through the NHS. But because their trial vaccines weren’t licensed, they can’t prove their vaccine status outside the UK, which means many countries are forcing them to self-quarantine.
If they had received the Pfizer, AstraZeneca or Moderna vaccines, they could travel using vaccine passports through the NHS app or other documents.
Professor Van-Tam revealed he made the proposal during a conversation with a Novavax volunteer at an awards ceremony on September 1.
Ffyona Dawber, who runs a medical communications agency and was also a guest at the ceremony, approached Van-Tam at her table at the Grosvenor House hotel in central London.
“He was very accommodating,” Dawber said. “As soon as I said, ‘I’m on the Novavax trial’, he put his head in his hands and said, ‘Oh my God, this is a disaster.’ He asked her sympathetic questions about her situation, Dawber said.
“I said, ‘I realize you can’t influence international borders’ and he said ‘no, no, no’ – he said he proposed to the government that the UK hold back all future clinical trial data from the EU if the EU did not let our vaccinated clinical trial subjects into their country. He added that the proposal was denied, she said. government did not dispute his account of the conversation.
The withholding of clinical trial data would be unprecedented and the proposal indicates how convinced Van-Tam is about the matter. In June, he wrote an open letter promising the trial volunteers that they “would not be at a disadvantage if world travel resumed.”
“He is fully aware that this will have a huge negative impact on people testing in the UK in the future,” Dawber said.
The ministers are said to have spoken to their counterparts in Europe about the recognition of trial vaccines. An alternative solution would be for trial volunteers to receive an NHS-approved vaccine.
Last week Dawber and hundreds of other volunteers formed the Novavax UK Concerned Participants Group and written to Sajid Javid, the secretary of health, asking him to allow them to receive approved vaccines.
Dawber has been unable to travel to the Netherlands to visit her Dutch husband’s family since the start of the pandemic, and she is also concerned about working abroad with her consulting firm, which trains them. doctors to new treatments and surgical practices.
“We have a job in December in France, and I probably won’t be able to go and do it,” Dawber said. “So unless that is fixed, that will start to impact the business as well.
“We did everything we could to help. And now we are not allowed to have a licensed vaccine. It just seems like madness.
Some members of the group with their families abroad lied to NHS clinics about their immunization status out of desperation.
A volunteer in Scotland, who has family in the Czech Republic, went to a walk-in clinic but was turned away because she told them she had participated in a trial.
“I decided to go to a reception center and lie,” she said. “It was the only thing I could think of to get the vaccine and see my family. I felt terrible for doing this, but I had no choice. In June, I heard that another study was recruiting. You would be crazy to do that. Everyone assumes you are getting paid, but you are not.
Another volunteer, Gillian Ince, who took early retirement as a learning and development manager at a large American company, was hoping to go on vacation next January.
“I actually feel trapped in my own country,” she said. “I feel like a prisoner of blood. It’s like the most horrible situation I’ve ever been in my life, because there is nothing I can do.
“I have sleepless nights and I feel very anxious. People who have done phase three like me – we all feel very disillusioned. We have been left in the dark. You feel absolutely terrible. It’s hard to describe how disappointed I feel.
Approval of the Novavax vaccine was expected earlier this year, but is now not expected for at least two months, leading some of the 15,000 volunteers in the trial to drop out. Last week, the British government said it would not go ahead with the planned purchase of 100 million doses of the Valneva vaccine. The company said it will continue to seek approval from the Medicines and Health Products Regulatory Agency.
Because the vaccines are being tested in double-blind clinical trials, none of the participants knew if they had received a Covid vaccine or a different treatment, so there was no peace of mind for those who were more vulnerable. to the virus.
A government spokesperson said: “The clinical trials of the Covid-19 vaccination have been instrumental in getting us to the point where we have safe and approved vaccines and they are providing critical data to help us respond to this pandemic.
“We are clear that volunteers in officially approved Covid-19 vaccine trials in the UK should not be at a disadvantage with vaccine certification policies, and we are committed to taking action on this issue, including by reviewing supplemental immunization guidelines for this group. “