Dear Vaccine Trial Participant,
Receiving additional approved vaccine(s) after trial of not-yet approved vaccines
Thank you again for your participation which continues to enable progress to be made in the development of effective vaccines against COVID-19. The world owes you a debt of gratitude.
There is an expectation that the vaccines trialled in Phase 3 studies in the UK will offer strong, long-lasting protection against COVID-19, even if they have not yet been approved.
This letter provides important additional information for trial participants on booster vaccines and how they may obtain a COVID Pass for international travel purposes, if needed.
The Government’s expert committee, the Joint Committee on Vaccines and Immunisations (JCVI), together with Chief Investigators of the clinical trials, have been considering the options in order to provide data-based advice on the risks, benefits, and the best approach to protect COVID-19 vaccine clinical trial participants. The new arrangements apply only to England at this time. They will be rolled out gradually, we would like to ask once again for your patience in being able to get appointments to discuss additional vaccines with your trial team.
Booster vaccines and flu
COVID-19 booster doses are being rolled out to people who are in priority groups, including health and care workers, people with certain health conditions and older people, who have had their primary course at least 6 months ago. We are aware that there has been uncertainty about the position of trial participants which we can now clarify as below.
In consultation with the JCVI and the NHS, the plan agreed is:
- Trial participants (who are not on a booster trial) can be offered a booster, in line with their priority group.
- If invited by the NHS, you may go ahead and have a booster dose. On some trials, you may be offered a trial vaccine, which you opt for instead and can have if you choose.
- You should not take up a booster dose if you are on an active booster trial, such as Cov-Boost, AstraZeneca Beta Variant or Sanofi booster, or if you have already had a booster dose on your trial, unless your trial team contacts you to suggest this.
- You do not need a booster earlier than the rest of the population in your priority group.
- Common side effects can be expected after additional doses, as with initial doses. These may include headache, arm pain and mild fever.
- It is important to be aware that the need for, and safety of, additional boosters after trial vaccines has not been fully evaluated and approved by the regulators in the normal way.
Boosters for trial participants are available from certain vaccination centres only, for the time being (unless you were on a trial for a vaccine that has since been approved, in which case you can access a vaccine in the normal way from any centre when you receive your invitation). Please inform the person giving you the vaccine that you are on a trial. Vaccine centres have been informed of the government’s position on booster doses for trial participants. Please tell the trial team when you had your booster at your next appointment.
Whether or not you have a booster COVID-19 jab, we recommend that you have your annual flu jab in line with NHS guidance.
Demonstrating a full course of approved vaccine / international travel
We recognise that many trial participants have been unable to take advantage of some of the benefits offered to people who have received a full course of approved vaccine, particularly overseas travel.
The UK government is working with international partners to ensure that trial participants are recognised. The government is continuing active conversations with other countries, including through groups such as the G7, the EU Commission and the WHO to shape the approach taken around the world to sharing health status for travel, including vaccination status. However, there is currently no internationally agreed policy on trial participants, and we recognise each country sets their own requirements for entry, and we are aware that many do not recognise trial vaccines.
Novavax, Valneva, Medicago and Com-Cov2 trial participants
In consultation with the JCVI, advice has been produced for participants who wish to receive additional doses of approved vaccines, on top of the trial vaccines. This will make it easier for participants to travel overseas. This advice applies to participants on the Novavax, Valneva, Medicago, and Novavax recipients on the Com-Cov2 trial only, as these are the only trials affected by the travel issue.
It is important you are aware of potential risks of having additional doses, which may be without any clinical benefits. Before having any additional doses, please be aware of the following information:
● Safety of additional dose(s). While booster doses following the Astra Zeneca and Pfizer vaccines have now been approved, there are no studies which provide data when two additional doses are given, and no studies where the new, as-yet unapproved vaccines, have been used as the primary dose with 2 additional doses. We cannot confirm the safety of one or two doses of approved vaccine on top of a full course of trial vaccine (three/four active vaccine doses in total). It is therefore important to discuss the possible risks against benefits with a doctor who is part of the team supporting the trial you are on. You will be exposed to any possible side-effects from further vaccines. The vaccine may not offer you any greater protection against COVID-19.
● International travel. It is important to check the requirements of the country participants wish to travel to, which change frequently. Some countries recognise trial vaccines, or allow entry with swab tests, so there may be no need for an additional vaccine. On return to the UK, UK trial participants have already been given the equivalent status of travellers entering the UK who have received approved vaccines.
● Documentation. The COVID Pass service will be further developed to display the additional approved vaccine doses for international travel. The service will show your additional approved vaccines two weeks after the full course of additional doses has been received. This development is underway and is expected to take a maximum of 10 weeks, which is how long it will take to receive the two additional vaccine doses. Updates will be shared on the Be Part of Research website.
● Timing. In order to be recognised as vaccinated with approved vaccines, participants will generally need 2 doses, 8 weeks apart, with an additional 2 weeks after the second dose, before they are considered to have had an approved vaccine (likely to be a minimum of 10 weeks from the date of your first approved vaccine). We do not know if and when trial vaccines such as Novavax will receive regulatory approval across the world, meaning it is possible further vaccination may be unnecessary by the time of your travel.
● Clinical trial participation. Every participant makes an important contribution to the collection of data about the safety and effectiveness of trial vaccines. We are very grateful for your willingness to help and the time you have given to help identify effective vaccines. Some participants have expressed that they no longer wish to be involved, but if too many participants leave the trial early to receive approved vaccines, there may be a risk that there will not be enough data collected for authorisation, as well as important long term safety follow-up on participants. As a result, we would encourage as many participants to stay in the trial for as long as possible. You are of course free to withdraw from the trial at any time, for any reason, and we appreciate all the time you have given so far. Please just let the trial team know. For some trials, you may be able to stay in for follow-up and monitoring even after receiving additional approved vaccine(s).
If you want to have an additional vaccine to enable travel, please note that this has to be a personal decision made by you in discussion with a doctor who is part of the team supporting your trial, accepting the risks outlined above. You can request it from certain regional centres in England that have been working with the clinical trials. Please take this letter with you.
Booking and receiving your additional vaccine
It is important that you have the opportunity to discuss whether you wish to have additional vaccines with a doctor who is familiar with your trial. This is so that they can talk through any benefits of additional vaccine against the risks, for your particular case. Please do not just arrive at any vaccine centre or try to book your appointment through the 119 system ahead of this.
Your trial site will be in contact with you, as soon as they are ready to offer you an appointment, should you wish to have an additional vaccine. The process of counselling participants who want travel top-ups and arranging for their vaccination will take some time and we ask for your patience as this is rolled out across all sites. We would ask that participants do not call or attend trial sites without an appointment unless they have an urgent concern. This is so that they can put arrangements in place, to support participants through this process. Thank you for your patience as this is offered to all participants as early as possible.
More details will be confirmed on the Be Part of Research webpage (bepartofresearch.nihr.ac.uk/Vaccine-studies/Latest-vaccine-news).
Thank you again for your participation and the important contribution this has made and for your patience whilst this issue has been looked into
