England’s deputy chief medical officer asked ministers to withhold all UK clinical trial data from the EU if European countries continued to deny entry to British vaccine trial volunteers, the Observer can reveal.
Jonathan Van-Tam made the extraordinary proposal after months of uncertainty for the 19,000 volunteers who are effectively unable to travel to Europe to see family, work or go on holiday because they took part in trials of Novavax and Valneva.
Because neither treatment has yet been approved by medical regulators, people who received vaccines during the trials are faced with a catch-22. They have had two doses, so they are not allowed other vaccines through the NHS. But since their trial vaccines were unlicensed, they cannot prove their vaccination status outside the UK, which means that many countries require them to quarantine.
Had they received the Pfizer, AstraZeneca or Moderna vaccines, they would be able to travel using vaccine passports via the NHS app or other documentation.
Professor Van-Tam revealed that he made the proposal in a conversation with a Novavax volunteer at an awards ceremony on 1 September.
Ffyona Dawber, who runs a medical communications agency and was also a guest at the ceremony, approached Van-Tam at his table at the Grosvenor House hotel in central London.
“He was very amenable,” Dawber said. “As soon as I said, ‘I’m on the Novavax trial’, he put his head in his hands and went, ‘Oh God, that’s a disaster’.” He asked her sympathetic questions about her situation, Dawber said.
“I said, ‘I realise you can’t influence international borders’ and he said ‘no, no, no’ – he said that he had proposed to the government that the UK withhold all future clinical trial data from the EU if the EU did not let our clinical trials subjects who’d been vaccinated into their countries.” He added that the proposal had been refused, she said. The government did not dispute her account of the conversation.
Withholding clinical trial data would be unprecedented and the proposal indicates how strongly Van-Tam feels about the issue. In June, he wrote an open letter promising trial volunteers they would “not be disadvantaged as global travel resumes”.
“He is acutely aware that this will have a huge negative impact on people doing trials in the UK in the future,” Dawber said.
Ministers are understood to have spoken to counterparts in Europe about recognising trial vaccines. An alternative solution would be for trial volunteers to receive an approved NHS vaccine.
Last week, Dawber and hundreds of other volunteers formed the Novavax UK Concerned Participants Group and wrote to Sajid Javid, the health secretary, 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 pandemic began, and she is also concerned about overseas work with her consultancy, which trains doctors in new treatments and surgical practices.
“We’ve got a job in December in France, and I probably won’t be able to go and do that,” Dawber said. “So unless this is sorted, it’s going to start to impact the business as well.
“We’ve gone out of our way to help. And now we are not allowed to have a licensed vaccine. It just seems to be madness.”
Some in the group with family overseas have lied to NHS clinics about their vaccine status out of desperation.
One volunteer in Scotland, who has family in the Czech Republic, went to a walk-in clinic but was refused because she told them she had taken part in a trial.
“I decided to go into a drop-in centre and lie,” she said. “That was the only thing I could think of to get vaccinated and see my family. I felt very bad about doing that, but I had no choice. In June, I heard another study was recruiting. You would be crazy to do it. Everyone assumes you get paid, but you don’t.”
Another volunteer, Gillian Ince, who took early retirement as head of learning and development at a large US company, had been hoping to go on holiday next January.
“I actually feel trapped in my own country,” she said. “I feel a bloody prisoner. It feels like the most awful situation I’ve ever been put in in my life, because I can’t do anything.
“I’m having sleepless nights and I feel very anxious. People who did the phase-three trial like me – we’re all feeling very disillusioned. We’ve been left in the dark. You feel absolutely crapped on. It’s hard to describe how let down I feel.”
Approval for the Novavax vaccine had been expected earlier this year, but is now not expected for at least another two months, leading some of the 15,000 trial volunteers to drop out. Last week, the British government said it would not go ahead with a planned purchase of 100 million doses of Valneva’s vaccine. The company said it would continue to seek approval from the Medicines and Healthcare products Regulatory Agency.
Because vaccines are 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: “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.”