A couple have been left “dissatisfied” and “angry” at their treatment as a part of the Novavax Covid vaccine trial.
Meanwhile, his wife Pam says she has been “left in limbo” after being given two doses of the vaccine that is yet to receive formal approval.
Bill, 72, said he signed up to take part in the Novavax test run in “good faith”, informing doctors that he was on anticoagulant medication when he first applied to the programme in October 2020.
But to his wife’s “horror”, after receiving his first dose at Hartlepool hospital he was handed a letter intended for his GP, which read that no patient should be prescribed anticoagulants if they’ve received the vaccine.
Pam explained: “I’d spoken to my doctor about Bill during my consultation, and they said he wouldn’t be a suitable candidate due to the medication he was on, so I was very surprised when he got a jab in the first place.
“And then when I saw the letter, I was immediately very worried that our GP might stop his anticoagulants.
“I took up the issue with the onsite doctor and weeks later I was called by a research nurse who informed us that Bill couldn’t have his second dose, because it went against trial protocol.”
Bill said it was a “damn nuisance” not to be given this information before entering the trial and that the mistake caused him “obvious concern and stress”.
During wintertime when vaccines such as AstraZeneca and Pfizer were granted approval, Bill was advised by trial doctors that he should take up one dose of an NHS vaccine.
Pam said she asked a lot of “searching questions” at this point because it had been 15 weeks since her husband’s first dose, and the recommended time in between is 12.
In the end, Bill decided to “take the bull by the horns” and booked two doses of AstraZeneca. As a result, Novavax made the decision to remove him from the trial.
Pam said this was “wrong” because Novavax “had a responsibility to monitor him after they made a mistake”.
The couple are equally frustrated with Pam’s experience of the trial.
Because Novavax is yet to approved she can not travel abroad freely and is unable to get a booster jab this winter or two doses of another already approved vaccine.
She said that volunteers “are being left in the dark”, and that nearly a year on from signing up, volunteers are “repeatedly” being told approval is “just weeks away”.
She added: “If we raise our concerns, we are told we are marvellous for taking part, but ultimately we remain in the same difficult position.”
She added: “People in our age group are going to a get a booster, but we’ve been told Novavax cannot give one.
“And since it’s recommended that we don’t have another vaccine, we are being left in a worrying position over the winter period.
“I’m totally dissatisfied with Novavax and the government’s involvement. We want action instead of being repeatedly fobbed off.
“It’s a shame because we came into this process wanting to play our part – but it’s ended up disrupting our lives”.
In response, a Novavax spokesperson said: “Novavax is grateful to clinical trial participants, who are a primary reason that some countries are able to begin reopening during this unprecedented global pandemic.
“We empathise with their concerns – and challenges – as the world begins to reopen.
“The UK government and Novavax are of the position and are making the case that those who participate in clinical trials should be treated in the same manner from a public health perspective as those who have received a deployed vaccine, and we continue to advocate for this.
“Regarding boosters, we have sought urgent guidance from NHS/JCVI, which they are actively considering, and will be sure to share updates as we have them.
“Clinical trial participants made a vital contribution during an unprecedented global pandemic. In addition to working day and night to complete the submission process, Novavax is doing all we can to advocate on their behalf to support proof of vaccination outside of the UK.”
The government, meanwhile, have said they are doing “all they can” to ensure that no volunteers from vaccine trials are disadvantaged and that any decision for a participant in a vaccine trial to receive an alternative vaccination should be made in conjunction with the clinicians who lead the trial.
A spokesperson from the Department of Health and Social care said: “ Covid-19 vaccine trials have been absolutely critical to developing safe and effective vaccines which have prevented 230,800 hospitalisations and 123,100 deaths – and that is thanks to the volunteers who made those trials possible.
“We are urgently working to resolve this issue and any decisions will be communicated directly to the participants and trial chief investigators as soon as possible.”
North Tees and Hartlepool hospital trust declined to comment.