Important information for participants in light of COVID-19 vaccine deployment

Important information for patients and the public

Thank you for your interest in COVID-19 vaccine research.

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.

Vaccine Passports/Certification and Travel

NIHR Statement - this update was issued on 11 June 2021

On 11 June 2021, Deputy Chief Medical Officer, Professor Jonathan Van Tam sent an open letter to all UK residents who volunteered to take part in vaccine studies.
Following this, the NIHR can confirm to vaccine trial participants that they have the same status as people who have received a deployed vaccine. A mini-certificate equivalent to what you would receive on the 119 service from the NHS will be issued to all participants.

NIHR Statement - Issued 11 June 2021

We appreciate the ongoing concerns of vaccine trial participants in relation to vaccine certification. We continue to work with the bodies responsible for NHS records on this, and there is Government commitment to resolve this quickly.

We understand the frustration this delay is causing participants and the evolving situation in relation to vaccine certification. 

We have been in numerous urgent discussions since our last update, including with the Chief Medical Officer’s team this morning and are hopeful of progress shortly. 

Study teams can be contacted to request proof of vaccination on letterhead. We will continue to keep our FAQs updated with the latest information.

Demonstrating your Covid vaccine status

People who have had a full course of vaccines at least two weeks beforehand, and can demonstrate this through the NHS App or paper alternative, can benefit from vaccine certification, or 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 https://www.gov.uk/guidance/demonstrating-your-covid-19-status and the country specific pages at https://www.gov.uk/foreign-travel-advice/.

There are separate immunisation systems in each nation in the UK, and different solutions for the certification. In England, if you have taken part, or are taking part, in clinical vaccine trials you will shortly receive a letter. The letter will ensure that anyone vaccinated as part of a vaccine clinical trial can prove they are in a clinical trial and therefore 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 Government’s website https://www.gov.uk/foreign-travel-advice 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.

I’m on a trial and can’t see my vaccine status on the NHS app or equivalent, why not?

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, 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.

I feel that people on vaccine trials have been disadvantaged by this delay.

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 demonstrate vaccine status is a concern for many people. 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 on solutions as quickly as we can.

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. Please refer back to this 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.

What do I need to do to get my vaccine trial status onto the NHS app or other system?

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. We expect this will be recognised by all countries that require evidence of vaccination before entry. 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.

Does the delay in approving the Novavax vaccine in the UK mean I should have a deployed vaccine to be on the safe side?

No. There is good clinical trial evidence already to show that the vaccines tested in the UK phase 3 trials are highly effective. The regulator, the MHRA, has the vaccines under rolling review and there has been no change to this. More information about the effectiveness of the Novavax vaccine was published on 14 June 2021.

The need for, and safety of, additional vaccine doses has not been demonstrated as yet. If in doubt, participants should seek further advice from the trial team.

Having an additional deployed vaccine now may not get you earlier vaccine certification compared with staying in the trial, as it would likely take 10 weeks to complete, and we expect to have a resolution within this time.

I was on the Janssen trial and this is now licensed. Why doesn’t this show on the NHS app?

The NHS data teams are working on this now. It will be pulled through so that you can demonstrate this, and we are sorry that we cannot confirm a timescale as yet.

My NHS app is showing my vaccine status as ‘exempt’. What does this mean?

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.

What about the position of people on the trials for monoclonal antibodies?

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

What is the advice for participants on trials who are offered a deployed vaccine?

Participants on some vaccine trials may have been offered an active vaccine or a placebo (that offers no protection against COVID-19). Now approved vaccines are available from the NHS, we want to make sure participants are not put at a disadvantage, and are able to have protection as quickly as possible, while still gathering important data on the effectiveness of the trial vaccines. Arrangements are being put in place so that all participants can receive an active vaccine, together with extra monitoring in the trial environment. The trial team will be able to collect further data that will help demonstrate effectiveness. This is being done through a crossover trial appointment. The crossover trial will offer you the active vaccine being tested on your trial, and will be provided through the trial team rather than the normal NHS vaccine deployment.

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. 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, who will make you an appointment. Older participants or those who are eligible for the deployed vaccine now are being prioritised. You still have the choice to unblind (find out whether you have had the active trial vaccine or a placebo) and if you had the placebo, you can choose to book an appointment with the NHS for an approved vaccine.

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.

Do we still need people to take part in COVID vaccine trials?

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.

What will the roll out of the approved vaccines mean for the trials?

The NHS are contacting people in an agreed priority order in the coming weeks and months to be vaccinated. We would want everyone taking part in the trials to be protected, alongside the rest of the population. Your safety is our highest priority. Processes are being put in place within studies to make sure trial participants are protected either through the approved vaccine or the trial vaccine.

Is it worth me joining a clinical trial now that we have approved vaccines?

It’s a personal choice but we believe it is. There is a process in place so people on the study are not disadvantaged. 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.

I’m on a clinical trial and not in a priority group for vaccination, what does this mean for me?

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.

I've been called up for my COVID-19 vaccine by the NHS but I am on a trial. What should I do?

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.

What will happen to people on the trials when they become eligible for an approved vaccine?

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.

What if I want to leave the clinical trial as a result of the vaccine roll out?

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.

Unblinding

I’ve been unblinded and told I’ve been given the active trial vaccine. What does this mean for me?

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.

I had the placebo vaccine, what should I do?

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.

Can antibody tests reveal whether I received an active vaccine or placebo?

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.

Crossover Trials

What is a crossover trial?

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.

How does the crossover phase of a trial work?

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.

How will participants on crossover trials be protected from Covid?

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.

Which vaccine will I be offered on the crossover trial and is it approved?

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.

If you have further questions about vaccine studies please visit our frequently asked questions page or visit approved vaccine studies.

You can find more information about how to get involved in other types of COVID-19 research and how it affects people in minority ethnic communities on our site.