Thousands of Britons who took part in Covid-19 vaccine trials are to be offered approved vaccines so they can travel abroad, the government has announced.
Trial participants have described feeling trapped and in limbo because they were unable to get a licensed Covid-19 vaccine, hindering their ability to leave the UK for business or pleasure.
But after taking advice from the Joint Committee on Vaccination and Immunisation (JCVI), the Department of Health and Social Care (DHSC) said those in England who took part in the UK-based Novavax trial should be offered two doses of the Pfizer/BioNTech jab, with eight weeks between the doses.
The health administrations in Scotland, Wales and Northern Ireland are expected to follow suit for vaccine trial participants in their regions.
More than 15,000 people took part in the phase 3 Novavax trial at various hospital sites across the UK, but the company has not yet submitted data to regulators to get the jab approved.
The UK already recognises those in Covid vaccine clinical trials as being fully vaccinated for the purpose of certification, both domestically and internationally. However, most other countries do not recognise clinical trial volunteers and require visitors to have been fully vaccinated with a vaccine that has been approved for deployment by the relevant medicines regulator.
Sajid Javid, the health secretary, appealed to global health leaders last month at the G20 meeting for clinical trial pioneers to have their vaccine status recognised globally. But with them refusing to shift their position, it has meant thousands of people continue to be unable to easily travel abroad.
The offer of two doses of Pfizer from next week means people will be able to travel more freely and have two doses of an approved Covid-19 vaccine on their health records, as well as via the NHS app. People will be able to get their extra vaccines following a discussion with an investigator from the Novavax clinical trials team.
The offer of two further vaccines will also be rolled out to participants in other relevant vaccine trials this month, the DHSC said.
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.
Prof Jonathan Van-Tam, England’s deputy chief medical officer, 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. 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.”
Prof Paul Heath, the principal investigator of the Novavax clinical trial across 35 sites, said: “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.”
Dale Moody, a Novavax trial volunteer, said he welcomed the move. “I am both relieved and elated about the decision to let Novavax volunteers have an approved vaccine for travel or as a booster,” he said. “It is a load off my mind.
“I was concerned that we had been cast aside. I had my second dose of Novavax in November last year and was worried about not getting a booster vaccine.”
Moody, 69, of Market Drayton in Shropshire, added: “I have family in Australia and was concerned that the uncertainties about the approval timescale of Novavax would prohibit visiting my family out there.”