Clinical trials will be offered “complementary” vaccine doses

• Trial participants will also be offered booster jabs, if they are eligible
• Move follows consultation with independent JCVI and medical experts

Participants in vaccine clinical trials will be offered the opportunity to obtain additional vaccine doses starting next week, to ensure they can travel abroad to countries that currently do not accept as vaccination records with COVID-19 vaccines approved for deployment.

The UK recognizes those participating in COVID-19 vaccine clinical trials as fully vaccinated for the purposes of certification, both nationally and internationally. The majority of other countries currently do not recognize clinical trial volunteers and require visitors to have been fully vaccinated with a vaccine that has been approved for deployment by the relevant drug regulatory body.

The government has therefore made the decision that those participating in clinical trials of the COVID-19 vaccine and who have not had a vaccine approved for deployment will have the opportunity to receive two additional doses of an approved vaccine. This will allow them to have the certification status necessary to travel abroad to countries that do not currently recognize trial vaccinations.

Additional doses will initially be offered to participants in the Novavax trial, which includes the vast majority of those participating in ongoing trials for vaccines that have not yet been approved for deployment. The offer will then be rolled out to participants in other relevant trials in the coming weeks. Participants in Novavax will be offered two doses of the Pfizer / BioNTech vaccine, with an eight week interval between the first and second dose.

In addition, people who have received both doses of a vaccine in a clinical trial will also be offered a booster vaccine, if eligible, in accordance with the broader advice of the Joint Committee on Immunization and Health. immunization (JCVI). This is to ensure that the protection they received from the vaccine in the trial is extended through the winter months.

This new approach, which will apply to England, was developed with the independent experts of the JCVI and the principal investigators of the clinical trials.

Deputy Chief Medical Officer Professor Jonathan Van-Tam said:

COVID-19 vaccine trials have been an integral part of our response to the virus, and as a result, we now have our renowned vaccination program, which continues to save lives. I urge as many people as possible to continue contributing to these trials.

The steps we have taken will allow UK participants in the COVID-19 vaccine trial to travel freely abroad once they receive the additional vaccinations. These volunteers now have the possibility to make a decision for themselves so that they can, for example, visit their relatives abroad.

We need to be very clear that the results of these trials are benefiting the whole world, and it must be said that if more countries around the world had reciprocated by allowing UK volunteers to benefit from fully immunized status for travel abroad, these measures would not have been necessary.

As a separate issue, those participating in the trials who are eligible for the boosters should be given the booster dose to ensure the highest possible protection during the winter.

The move follows a call by the Secretary of Health and Social Affairs to global health leaders last month at the G20 meeting for clinical trial pioneers to have their vaccine status recognized around the world.

NHSX and NHS Digital are working at a steady pace to reflect these doses in the COVID Pass for International Travel as soon as possible and further details will be provided in due course. Given the added value that participation in clinical trials brings to global public health and science, the UK already recognizes that trial participants are fully vaccinated and continues to urge other countries to do the same.

The government is working closely with its international counterparts to ensure that a longer term solution can be found for these people, and is in active conversation with other countries through groups such as the G7, the European Commission and the World Health Organization (WHO).

Letters will be sent shortly to clinical trial participants outlining more details and next steps. Participants will be contacted by the trial team, who can answer any questions and need not contact their NHS or local GP. Vaccinations will most likely take place in hospitals.

Booster injections for eligible individuals will be offered no earlier than six months after the individual’s second dose.

Principal investigator of the Novavax clinical trial, Professor Paul Heath, said:

I warmly welcome this development on behalf of the more than 15,000 Novavax trial participants and my colleagues at the 35 UK trial sites.

For too long, participants have been at a disadvantage in terms of international travel as this vaccine is not yet approved for deployment – but trial participants now have the option of receiving booster doses or additional doses for the purposes of travel, if they wish.

All clinical trial participants may already have access to an NHS COVID Pass for domestic use. They should have received a letter confirming their participation in the specific vaccine study and confirming that they have the same protected status as someone who received the approved vaccines. Participants should contact their clinical trial site if this is not the case.

Around 52,000 people are currently participating in trials across the UK, 21,000 of whom have received a vaccine that has yet to be approved for deployment by the Medicines and Health Products Regulatory Agency (MHRA). About 15,000 of them are participating in the Novavax clinical trial.

The Vaccine Working Group and MHRA are working with vaccine manufacturers to ensure their COVID-19 vaccines are cleared as quickly as possible, if they meet high standards of safety, quality and efficacy.

The decision to authorize a vaccine is made by the MHRA, which must carefully, independently and scientifically review the data to determine how it protects people against COVID-19 and the level of protection it offers.