If you have taken part in a vaccine study or are interested in doing so, please read the statements and FAQs below. If after reading the information you still need further assistance, please contact us.
Last updated: 29 July 2021
Statement from the Secretary of State for Transport
The following is an excerpt from a statement given by the Rt Hon Grant Shapps MP on 8 July 2021:
"The success of our vaccine programme has been aided by those selflessly creating the great benefits for society and for the rest of the world by being part of the clinical trials, without which we would not have this vaccine programme. We committed to ensuring they are not disadvantaged as a result of being part of those trials, and I am delighted to announce that those on approved clinical trials in the UK will also not need to self-isolate, or take the day eight test after arrival from an amber list country."
The NIHR is aware that uses of COVID vaccine certification are changing and that solutions are still being put in place for trial participants. We are regularly updating our FAQs below.
NIHR Statement - 11 June 2021:
Frequently asked questions
People who have had a full course of vaccines at least two weeks beforehand can demonstrate their vaccine status through the NHS Covid Pass and displaying their vaccine history- this is available via the NHS App, NHS.uk or as a paper alternative.
Vaccine certification is sometimes more commonly referred to as a ‘vaccine passport’. This sometimes exempts them from extra tests or quarantine in international travel and certain domestic events. There are usually alternatives, such as taking a test, available so people don’t need to be able to show they are fully vaccinated to travel or attend events. The latest information is available at Gov.uk Demonstrating your COVID-19 status and the country specific pages on the Gov.uk Foreign Travel Advice website.
There are separate immunisation systems in each nation in the UK, and different solutions for the certification. In England, participants have received a letter showing they are in a trial and should be treated as fully vaccinated. If you have not received your letter, please contact the clinical trial site where you took part in the trial. The letter can be used when demonstrating your COVID-19 status in England. This commitment was made by the Deputy Chief Medical Officer in an open letter on 11 June 2021.
If you wish to travel abroad, then you will need to continue to seek guidance on COVID-19 status requirements for the destination country you intend to travel to. The systems are developing rapidly and so it is a good idea to check the current situation by visiting the Gov.uk Foreign Travel Advice website or seeking advice from your travel company. Entry requirements for travel to different countries vary and can change frequently and with little warning. Most require PCR Covid tests, whether or not people have had a full course of vaccine. Only people who have had a full course of vaccines at least two weeks prior beforehand would be eligible for vaccine certification.
Information on trial vaccines has not yet been fully entered into NHS data systems. This is because of different IT systems, but also the complexities of these trials. The trials involve both placebo and active vaccines, but certain information is hidden (also referred to as ‘blinded’) during the trial and follow up period, to help ensure the best quality data from the research. The systems also need to show that these trial vaccines, although not yet approved in the UK, or other countries, are equivalent to those that have been approved.
The UK Governments are committed to resolving this at speed with those responsible for NHS IT, including NHS Digital, so that trial participants are not disadvantaged when travelling. We have already been working on this for several months, alongside multiple partner organisations. We are sorry that this has not been resolved as yet.
We are really grateful to everyone who has taken part in these critical trials and do not want you to be at a disadvantage. We recognise how much vaccine volunteers have already contributed to society and do not want them to miss out on any benefits or feel anxious or that they are being ‘left behind’.
We appreciate that the fact that trial participants cannot currently use the NHS app to show their trial vaccine history is presenting problems for many people, including uncertainty, the need to pay for additional tests for travel and in some cases, problems accessing certain destinations. We are really sorry for the anxiety, stress and the feelings of injustice around this. We would like to reassure everyone who has taken part in the trials that we are aware of this at the highest levels, and are working with the NHS data organisations NHS Digital and NHSX on solutions they can implement as quickly as they can.
We also recognise that vaccine records on the NHS app will not be a complete solution, and there are some matters that are outside the control of UK authorities, including recognition of trial vaccines by other governments. If this is a serious problem for you, you are of course free to withdraw from the study at any time. We do recommend you speak to the trial team or your doctor for further advice before receiving additional vaccine on top of your trial vaccine.
People who have taken part in vaccine trials should not be disadvantaged domestically. This means that they will be eligible to go to test events and hospitality, they will be able to demonstrate this to their employers if required, and should be offered goods and services on the same basis as any other fully vaccinated UK resident in the UK. Vaccine trial volunteers have a letter that they can use to demonstrate this purpose and can also use the NHS app to demonstrate exemption or a ‘green tick’ to access test events. There have been delays in getting these domestic systems for the COVID Pass in place for trial participants, but these are expected to be resolved during July.
In terms of overseas travel and events, the UK Government is negotiating with other countries so that vaccine trial participants can have the same exemptions as other fully vaccinated people. However, some countries are not recognising vaccines not yet licensed, including Novavax, Valneva and Medicago, or those who cannot evidence which vaccines they had when. If you are planning to travel abroad, it is a good idea to check foreign travel advice on the Gov.uk website, and how your data appears on the NHS app (or equivalents).
I was part of a trial, when can I expect to see my vaccine status in the NHS app or be able to get a vaccine certificate?
We are working with the NHS data systems on a fix on this at the moment, and expect this to be live in the next few weeks. Participants should already be able to demonstrate a ‘green tick’ on the NHS app for domestic events. Full vaccine records are expected to be available from late July, although it will depend on your trial and trial site. Please refer back to the Be Part of Research website regularly, where we will post the latest situation. If you need to travel and would like evidence of your vaccine, your trial team will give you a letter with details on headed paper. We cannot guarantee that this will be accepted by cruise companies or foreign immigration control however.
You don't need to do anything, if you have had the full course of trial vaccine, including any crossover doses. As the information on vaccine trials was kept on a separate database to the national vaccination database, there needs to be a system to upload these records so they are visible. This is being worked upon at speed.
I was part of a vaccine trial, why can I see my vaccine status in my medical record but not through the app or other system?
Some volunteers' data may already be in their GP systems so they may be able to already see their status because those practices were involved in the trials or the GP has recorded information received via letters from the study team.
I was in a blind (placebo controlled) vaccine trial. How will I know if mine was an active vaccination?
Many of the volunteers on studies that involved placebo have now been offered an additional course of vaccine to make sure they had the active vaccine. This has been called a cross-over trial, where the volunteer may not know when they had the active vaccine, but can be assured they have now had it. Others have requested unblinding to see if they had received placebo (and if so have gone on to receive vaccine via the NHS). If you are still on a study where you may have only received placebo then please discuss this with your study team as unblinding or roll-over to active vaccination could be options if you so wish.
I've had an active vaccine on a trial, but not a licenced vaccine. Will this be adequate for travel?
Vaccines not yet licenced but which have been given as part of a phase 3 trial, will be recorded on your record. The Government is working with international partners on this. However, it is advisable to check this in advance on the Government's Foreign Travel Advice website and to remember that entry requirements for foreign countries and back into the UK can change frequently. Some countries may not recognise vaccines that they have not yet licensed (which may apply to Oxford/AZ, Novavax, and Valneva in particular).
I’m on a trial. Will I be able to demonstrate exemption from quarantine on return to England from an amber list country?
Yes. People who have been double-jabbed at least 14 days previously are expected to benefit from certain exemptions from quarantine when they return to England from an amber list country, from 19 July, the Government has announced. They will still need to pay for and take certain tests. Further details can be found on the Gov.uk website. People who have taken part in a trial and received a full course of trial vaccines will also benefit from this. This will be demonstrated through the NHS Covid Pass (on the NHS app) or an NHS Covid Pass letter, or similar documentation to demonstrate you were on a trial. Different rules are in place for Wales, Scotland and Northern Ireland.
NHS Digital are working with sites to get information pulling through to the NHS app before the end of July for foreign travel, and during July for domestic purposes. However, some countries are not recognising the Novavax vaccine, as it is not yet licensed. Please check foreign travel advice and refer to the question above.
There are two types of COVID Pass. One is for domestic purposes (the event trials such as Wimbledon). For clinical trial participants this will be demonstrated through a ‘green tick’ on the NHS app due to their participation in a clinical trial.
The second is for international travel and displays your COVID-19 vaccination history on the NHS app. Janssen participants will have one vaccine dose visible on this. We appreciate you may have had two doses, but to get a COVID Pass you only need to have received one dose of the Janssen vaccine, and the system only pulls through one date. It will have no impact on when you are called for booster doses for example, which will be based on age and health condition status rather than when you had the original vaccine doses.
If your COVID Pass (displayed as a ‘green tick’) for events or international travel, or your vaccination history are not yet visible on the NHS app, it is possible that the trial site has had difficulty uploading your record. Please contact them for further advice if you need to travel urgently.
This gives you Covid vaccine status for use at any domestic events, and the Government is working on it being recognised internationally. It will be replaced by details of the exact vaccine you have had when this is possible.
No. We are sorry that participants have been disadvantaged on foreign travel plans and in some cases, have had to incur additional costs for PCR tests for example. However, we have no control over the entry requirements set by other countries. The NHS does not cover tests for people wishing to travel abroad. The UK Government is taking steps to make sure that vaccine trial participants have equal status domestically to people who have had a deployed vaccine. They are also working with international organisations and other countries on their entry criteria.
We don’t expect that any vaccine certification system will apply to these trial participants at the moment, as there is uncertainty as to how long the protection will last for. Participants can access testing instead, or speak to the trial team if they want to explore getting a deployed vaccine instead, if they feel they need vaccine certification.
Approved COVID-19 vaccines
The Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines are now being rolled out across the UK.
These developments are a tribute to the global efforts of the life sciences industry, researchers and volunteers, underlining the importance of this vaccine research. It is thanks to you and all those involved, that we have this encouraging news about vaccines.
It is important that clinical trials into a number of other COVID-19 vaccines continue. Different vaccines work in different ways and we still need to collect important information about which vaccines work best, and are best for different groups of people, and on exactly how effective they are at, for example, preventing severe infection, preventing infection as a whole, preventing transmission etc. We also need information on matters such as the best way to use vaccines, the number of doses, and to check long term that there are no safety concerns.
Keep taking part
It is really important that people keep taking part in all the COVID-19 studies, attending their follow-up appointments and submitting data on their health and COVID infections. We need volunteers to join new studies and existing studies are not yet complete, and we need the long term data to help us understand how best to use the vaccines, which are most effective and to give information on the levels of effectiveness, as well as reassurance on long term safety of them.
Here are some answers to questions you might have about what these developments mean for the clinical study you are taking part in.
Thank you for your continued interest in COVID-19 vaccine research.
I’m in a special sub-group, an earlier phase trial or the monoclonal antibody studies. Does this advice apply to me?
There may be different advice for people on some of the special or earlier phase trials. In particular, people on earlier phase trials where there isn’t the same amount of information available about the likely effectiveness of the trial vaccine may be advised to have the approved vaccine on top of the trial vaccine. If you have had the monoclonal antibodies (Provent or Stormchaser trials), it is important that you speak to the trial team for further advice.
Yes, the trials will continue because we need data about a number of different vaccines and their safety and effectiveness, in order to protect the population.
We need several vaccines to ensure an adequate supply and because some vaccines may be easier to transport and store than others. We need further data on whether one or other vaccine is better suited to specific groups of people, such as older people or people with other medical conditions, and all the trials are giving information on safety, which is so important to gather.
Thank you for your participation - it is thanks to people taking part in trials that we now have approved vaccines.
It’s a personal choice but we believe it is. All the studies now recruiting will give you an active vaccine during the trial. Taking part in a study is the best way to help effective vaccines to be identified and made available to everyone earlier, and may even give you early access to a vaccine later found to be effective.
I'm on a clinical trial and in a priority group for vaccination, how will I be offered early protection?
Now that approved vaccines are available, people in priority groups will be contacted by the NHS and offered an appointment to receive it.
From February 2021, this includes people over 70, health and care workers and people who are extremely clinically vulnerable, and is being rolled out by age to younger people. When you are invited to a vaccine, please contact the research team, who will follow an agreed process to advise you. This is likely to include finding out whether you received an active trial vaccine or a placebo (that would offer you no protection against COVID-19), called ‘unblinding’.
If you had an active vaccine, the research team will advise you if you still need to have the approved vaccine, taking into account the latest data on the trial vaccine’s effectiveness. If you had a placebo, you will be advised to have the approved vaccine.
Please continue to attend follow-up appointments and the advice of the research team, so that we can gather important safety information about the trial vaccine. It will be important that we gather information about the safety and effectiveness of all the trial vaccines underway. This is so that we can gather information to allow use of all the effective vaccines, to maximise supply and ensure that we gain a full picture of the effectiveness and use of all the vaccines available.
Please continue to take part in the clinical trials, attend for your follow-up booster (if applicable), and all your follow-up appointments. We are asking people to continue to take part in clinical research for as long as possible.
Please contact the research team, who will advise. If you have been on a placebo controlled trial (meaning some participants will have no protection), there are two options. One is an ‘unblinding’ process, which means finding out whether you received an active trial vaccine or a placebo. The other is to wait for the crossover trial, which means offering the participants who were on the placebo arm, the active trial vaccine.
Important: Whether you are on the placebo or active vaccine trial arm, and whether you have an approved vaccine or not, please continue to attend follow-up appointments and take the advice of the research team, so that we can gather important safety information about the trial vaccine. This is so that we can gather information to allow use of all the effective vaccines, to maximise supply and ensure that we gain a full picture of the effectiveness and use of all the vaccines available.
I’d prefer to have an approved vaccine, on top of a full course of the active trial vaccine. Is this advisable?
If you have received the full trial dose or doses, you will be advised NOT to have an approved vaccine (which is the current national guidance from the independent expert group). This is because the risks of receiving the approved vaccine after a full dose of trial vaccine are unknown and also because there is a good expectation that the active trial vaccine could protect you. It is very important to speak to the research team as only they can help you with the key information on the risks and benefits of your options.
The current vaccine trials have studied the benefits and safety of individual vaccines. We do not have evidence for the benefit and safety or risks of having an additional vaccine over and above the trial doses, so the risks are unknown. There may be a risk of increased side-effects, such as pain at the injection site and flu-like symptoms. If you choose to have an additional course of vaccines, it is advisable to ensure there is an adequate gap between vaccines and the trial team could advise on the appropriate time.
We want to make sure people on the trials are offered protection, as soon as, or even before, they are offered an approved vaccine. Participants can also request to be unblinded so they can go and get an approved vaccine, but there is a process in place so participants can get an active vaccine while they are on the trial, instead of going separately for an approved vaccine.
There are two types of trials, those that tested against a placebo (that offers no protection against COVID-19), and those testing against an active vaccine (that is hoped will be effective or may have already been approved as effective). All trials now recruiting in the UK will be looking at active vaccines, meaning all participants will be offered an active vaccine during the trial. Some of the active vaccines in some of these trials have not yet been approved, and their effectiveness has not been fully evaluated.
Everyone who has taken part in a placebo-controlled trial is now being offered an active vaccine. This happens through the ‘crossover’ stage, where participants are offered two extra appointments, where they are given a jab that may be an active vaccine (if they had the placebo in their first two jabs) or may be a placebo (if they had the active vaccine in their first two jabs). This is done without ‘unblinding’, so participants don’t find out when they actually had the vaccine, but can be reassured they are now protected.
Participants are free to leave at any time, and this is a personal choice. If you are anxious about staying in the trial, do speak to the research team who can probably help you with any concerns and help you with information about leaving. We would encourage people to stay in the trials until they are called up for an approved vaccine, and to continue with the follow up appointments after that. The longer people are in trials, the more data can be gathered, and the earlier the trials can complete, and hopefully produce more data on effectiveness of the vaccines.
When you are unblinded, you will be supported with further advice. If you have received the full trial dose or doses, you will be advised not to have the approved vaccine (which is the current national guidance from the independent expert group).
This is because the risks of receiving the approved vaccine after a full dose of trial vaccine are unknown and also because there is a good expectation that the active trial vaccine could protect you. As more evidence from the trial is developed, further advice may be offered to you if necessary. Please continue with the follow-up appointments.
If you are advised that you were given the placebo and are subsequently called up for the approved COVID-19 vaccine, it is recommended that you take this up. The placebo will not give you any protection against COVID-19. Please continue to attend your trial appointments.
No. Antibody tests have been developed to give an idea of whether someone has had coronavirus infection (even if they had no symptoms). However many of these tests look at antibodies to parts of the coronavirus that are not contained within the vaccines. Therefore you may have had an excellent response to the vaccine and be protected from infection, but the antibody tests will be negative.
An antibody test should not be used to determine if you have had active vaccine or placebo in a trial, or to see how good a response you have had to a vaccine, as they cannot reliably provide this information.
This type of trial offers participants who were on the placebo arm, the same active vaccine that is being trialled. You will receive the vaccine from the trial team, rather than through the NHS vaccine deployment service. The trial team will contact you to offer you an appointment. At the appointment, if you received the placebo vaccine (the dummy vaccine), you will be offered an effective active vaccine. This will allow the trial team to collect more data without participants going through the unblinding process and receiving an approved vaccine from the NHS.
You do not have to do anything at this stage. At your next trial visit (or sooner if you have already been offered the deployed vaccine), you will be offered an active vaccine if you received the placebo (dummy vaccine) initially. This is expected to start from late March. The trial team will contact you to offer you an appointment. If you are not called before you are offered a deployed vaccine, you can contact the trial team.
At a future time-point, participants will be offered the chance to have the active trial vaccine if they had the placebo initially. This is called a 'crossover' trial. It means that all participants will get the benefit of the active trial vaccine, together with extra monitoring in the trial environment. The trial team will be able to collect further data that will help demonstrate effectiveness. There would not be a need for participants to unblind and come off the trial to receive an active vaccine.
You will be offered the same active vaccine as on your trial (so the Novavax vaccine for the Novavax trial). The approval process is underway for a number of these vaccines at the moment, but may not have been completed. Your trial team can give you further information on the latest status.
Will supply of vaccines for the crossover trial be affected by any shortages affecting the national deployment?
No, there are dedicated vaccine supplies for the crossover trial. You would not be affected by any shortages of supply affecting the national scheme.