Vaccine trials

People who took part in trials for COVID-19 vaccines which have not yet been authorised for use in the UK will be able to request an additional primary course of approved vaccinations.

The change is set out in the latest recommendations by the Joint Committee on Vaccination and Immunisation (JCVI) and is aimed at easing the problems faced by some participants in trials for vaccines, such as Novavax, Medicago or Valneva, in accessing international travel.

People who have taken part in vaccination trials should also receive booster jabs if they are eligible, the latest JCVI guidance confirms.

Chief Medical Officer Dr Gregor Smith has written to health boards setting out the new advice. Trial Principal Investigators will also write to participants informing them that they can now seek an additional course of primary vaccination.

Dr Smith said: "I am extremely grateful to everyone who has taken part in COVID-19 vaccine trials in Scotland for the important contribution they have made in tackling the pandemic.

"The Scottish and UK Governments have been working with international partners to agree recognition for COVID-19 clinical trial participants, but there is still currently no internationally agreed policy.

"Allowing participants in trials for vaccines which are not yet authorised in the UK to request another primary vaccination course with authorised vaccines should help to resolve this situation. The JCVI has also agreed that those who have participated in clinical trials will be offered a booster vaccination in accordance with the criteria set for the wider booster programme."

Trial participants, who would like to discuss the possibility of receiving a primary course of a UK authorised vaccine, should contact the Principal Investigator (PI) organising their trial in the first instance.

Once vaccinated with an additional primary course, individuals will be able to travel internationally in the same way as anyone vaccinated in Scotland, with their record of vaccination showing them as fully vaccinated with a UK authorised vaccine.

Background

• About 1500 people in Scotland have taken part in trials for vaccines which are not currently authorised for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA)
• Trial participants who receive an additional course of UK authorised vaccine will have this added to their digital record of vaccination which will allow for international travel and use of digital tools to display vaccination status (such as the COVID status app).
• After discussing the risks and benefits of an additional vaccination course with trial Principal Investigators, the PI can issue a Patient Specific Direction (PSD). This will allow the participant to receive a full primary course of an authorised MHRA vaccine through the national vaccination programme.
• In Scotland, participants in vaccine trials involving vaccines which have subsequently been authorised for use, namely Oxford-AstraZeneca (Spikevax), should now be able to access their record of vaccination through standard channels.
• Participants in trials with vaccines not currently authorised for use in the UK, such as Novavax, Medicago or Valneva, have so far been sent a paper certificate containing a 1D barcode, as opposed to certificates for routine vaccination (i.e. a vaccination authorised for use in the UK) which contain a 2D QR code.