Covid-19 vaccine trial volunteers will be offered two further doses of an approved vaccine to enable them to travel abroad, the government has announced.
Trial participants previously described feeling “trapped” and “in limbo” over their vaccination status after being turned down for an approved vaccine.
The Department of Health has now said those in England who took part in a UK-based trial should be offered two doses of the Pfizer/BioNTech jab, with eight weeks between the doses.
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It means trial participants will be able to travel abroad to countries that require proof of an approved vaccine, and be able to get a Covid pass using the NHS app.
The first doses will be offered to those who took part in the Novavax vaccine trial from next week.
More than 15,000 people took part in the phase 3 vaccine trial at various hospital sites across the UK, but the company has not yet submitted data to regulators to get the jab approved.
The offer of two further vaccines will also be rolled out to participants in other relevant vaccine trials in the coming weeks, the Department of Health said.
In addition, if people from the Novavax study are eligible for the Pfizer Covid booster jab currently being rolled out across the UK, the booster dose can count as the first of the two doses that are needed for travel.
Principle Investigator of the Novavax clinical trial Professor Paul Heath said: “I very much welcome this development on behalf of the more than 15,000 participants in the Novavax trial and my colleagues in the 35 UK trial sites.
“For too long the participants have been disadvantaged in terms of international travel because this vaccine is not yet approved for deployment - but trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish to.”
England’s deputy chief medical officer, Professor Jonathan Van-Tam, said: “Covid-19 vaccine trials have been absolutely integral to our response to the virus, and as a result we now have our renowned vaccination programme, which continues to save lives. I urge as many people as possible to continue contributing to these trials.
“The measures we have taken will allow UK Covid-19 vaccine trial participants to travel freely overseas once they have had the additional vaccinations.
“Those volunteers now have the flexibility to make a decision for themselves so they can, for example, visit loved ones abroad.
“We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary.
“As a separate issue, those in trials who are eligible for boosters should receive the booster dose in order to ensure the highest possible protection over winter.”
No evidence exists to date on administering four doses of different vaccines, although experts do not expect significant issues.
However, there is evidence that mixing three doses of different vaccines is safe, as set out in the COV-Boost vaccine trial.
Last month, the Novavax UK Concerned Participants Group launched a petition on change.org calling for help from health secretary Sajid Javid.
The group said UK volunteers were “significantly disadvantaged” because of the barrier they face around international travel.
The petition said: “We call on the ministers to rectify the situation immediately so that Novavax volunteers can travel as freely as other vaccinated people."
Gill Ince, who participated in the trial in September 2020, said she felt like she was “living in limbo”.
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."
There are around 52,000 people currently taking part in trials across the UK, with 21,000 given a vaccine not yet approved for deployment by the Medicines and Healthcare products Regulatory Agency (MHRA).
The government said the Vaccine Taskforce and the MHRA are working with vaccine companies to ensure the vaccines are authorised as quickly as possible, if they meet the high standards of safety, quality and effectiveness.
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