Thousands of Covid jab trial volunteers ‘trapped’ without vaccination status

Some 15,000 Britons took part in the Novavax clinical trial.
Gill Ince participated in the Novavax trial in September 2020 (PA)
Ella Pickover20 September 2021

Ministers are being urged to help thousands of people who took part in Covid-19 vaccine trials who cannot prove their vaccination status.

Trial participants have described being “trapped” and “in limbo” because they are unable to get a licensed Covid-19 vaccine or travel abroad.

Around 15,000 Britons took part in the Novavax Covid-19 vaccine clinical trial.

The vaccine is yet to be approved for use in the UK.

I wanted to do my bit to fight Covid but I feel utterly betrayed by the system and I’m trapped without any vaccination status

Trial participant Gill Ince

People who took part have said that despite being vaccinated, and volunteering to enhance medical science early on in the pandemic, they are unable to enjoy the same freedoms as the general population.

A petition has been launched on change.org calling for help from Health Secretary Sajid Javid.

The petition, launched by the Novavax UK Concerned Participants Group, states that UK volunteers are “significantly disadvantaged” because they face barriers to travel and are unable to get another Covid-19 vaccine.

“We call on the ministers to rectify the situation immediately so that Novavax volunteers can travel as freely as other vaccinated people,” the petition states.

Retiree Gill Ince, who participated in the trial in September 2020, said she felt like she was “living in limbo”.

We have no idea if, where or when Novavax will be approved so now we are living in limbo. It’s incredibly stressful and I feel like a prisoner

Trial participant Gill Ince

The 61-year-old, from Oxfordshire said: “I stepped forward early in the pandemic to participate in a vaccine trial.

“I wanted to do my bit to fight Covid but I feel utterly betrayed by the system and I’m trapped without any vaccination status.

“I was given reassurances that I would not be disadvantaged in anyway at a later date.

“We have no idea if, where or when Novavax will be approved so now we are living in limbo.

“It’s incredibly stressful and I feel like a prisoner.

“It feels like the most awful situation I’ve ever been put in in my life, because I can’t do anything.”

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

Government spokesperson

The Observer reported on Sunday that England’s deputy chief medical officer Professor Jonathan Van-Tam suggested to the Government that the UK withhold clinical trial data if vaccine trial participants were not being allowed into European countries.

A Government spokesperson said: “Covid-19 vaccine trials have been absolutely critical to developing safe and effective vaccines which have prevented 230,800 hospitalisations and 112,300 deaths – and that is thanks to the volunteers who made those trials possible.

“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.

“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 Novavax spokesperson added: “Novavax is in active conversations with various regulatory agencies, including MHRA, EMA, WHO, FDA and others, and is working on the completion of our rolling submissions.

“Novavax is in alignment with these regulatory authorities on the final requirements to complete these submissions. As a result, there is additional work under way and we now expect that these final filings, including to MHRA, will occur in close proximity to each other in the next couple of months.

“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.”

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