COVID-19 vaccine studies

Frequently asked questions

Here are the most commonly asked questions that members of the public ask about vaccine research. To find frequently asked questions you might have about what recent developments mean for the vaccine study you may be taking part in, visit the Latest Vaccine News page. More general questions and answers can be found on our COVID-19 page.

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.

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.

General

What will taking part in coronavirus research involve?

If you take part in a vaccine study, you may or may not be offered the vaccine. Vaccines are tested to make sure they're safe before being tested in people.

You'll need to visit the hospital, or other research site, a few times over 6 to 12 months.

At these visits, you should:

  • be told about the research study
  • have the chance to ask any questions
  • have blood tests

Between visits, you'll be asked to tell the research team about any symptoms you have. You may also be asked to self-monitor at home, for example by doing swabs or keeping an e-diary. There are many different types of research taking place to tackle COVID-19. Here's how to get involved.

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

Yes. 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 protection.

We still need more research into the vaccines, to look at how best to protect communities and the population as a whole. Studies are underway or planned on:

  • new vaccines, so that there are enough vaccines to protect everyone
  • special groups such as pregnant women, children and young adults, and those with a weakened immune system
  • how best to use existing vaccines, looking at dose of vaccine, the interval between giving the first and second doses, and whether the brand/type of vaccine given for first and second doses makes a difference to effectiveness
  • giving flu vaccine at the same time as the COVID-19 vaccine
  • booster vaccines or third doses
  • vaccines against new variants of COVID-19

You can still have an approved vaccine when this is available, even if you take part in a study and there are arrangements in place to make sure you are not put at a disadvantage for protection.

Do COVID-19 vaccines contain meat products? Are COVID-19 vaccines vegetarian friendly? Are COVID-19 vaccines Halal/Kosher?

There are many COVID-19 vaccines in development at the moment. We don't have details on every ingredient yet, but many of the COVID-19 vaccines are expected to be vegetarian or vegan and as and when we start deploying vaccines in the NHS, individual details will be shared on individual vaccines.

The Pfizer BioNTech and Oxford/AstraZeneca vaccines are the first vaccines to be given to people in the UK and they do not contain any components of animal origin. They are vegetarian, halal and kosher friendly.

Is it alright to travel to take part in vaccine trials or other research in areas with high levels of COVID restrictions in place?

Yes. Please do continue to travel to take part in vaccine trials, other health research or for other healthcare requirements. Volunteers taking part in vaccine trials are even more important in areas highly affected by COVID at the moment. If you have concerns about travel to your appointment or how you will be kept safe during the appointment, please contact the research team for more information.

Will suitable volunteers who signed up first be more likely to take part than those that sign up now?

Taking part doesn't work on a first come, first served basis. Most vaccine studies will take place at multiple sites, like hospitals, across the country. Those sites may be looking for different groups of people to take part, some areas may need more people of a certain age for example.

So whether you are contacted to take part will be based on many factors including where you live and information about you and your health. Researchers will look at your answers to the questions asked when you register to see if you're suitable for their trial, and contact you if they think you may match what they need.

If I am contacted by a research study, how do I know the contact is legitimate?

In the UK, the research partner of the NHS is the National Institute of Health Research (NIHR). If you sign up to be contacted about vaccine studies, only researchers on studies supported by NIHR - and who have applied to use the service and been approved - will be able to contact you. You can view a list of NIHR supported COVID-19 vaccine studies above.

When researchers from an approved study contact you, the first email will be from an official nhs.net email address. In the list above, you can select an approved study to find out the official email address that you will receive an email from, if you match a vaccine study. Check this list to ensure the email you receive notifying you that you may be eligible for a study is legitimate.

If you are interested in a study you receive an official email about and decide to get in touch with the study team and/or complete the online screening as directed in the email, then the study team will be in touch with you directly. 

Researchers will never ask you for money or passwords. Always be alert to the risks of clicking on links or attachments. You can learn more about how to protect yourself from scam emails on the Action Fraud website.

Check back on Be Part of Research or contact the team if you are worried that an email may not be legitimate. Contact from researchers will be from one of the following email addresses: nhs.uk; nihr.ac.uk or ac.uk.

How will data collected about me in the study be used?

If you enrol on a vaccine study, the research team will collect information as part of that particular study. This information is held by the research team and any information that is collected about you will be kept confidential, in the same way as your medical records.

  • If your doctor or consultant is not the person who approached you about the study, it can be helpful for them to be told you are taking part in a study as they will be responsible for your day-to-day healthcare; but they can only be told with your permission.

  • Once the study has finished the results are usually published, and often presented at conferences. No name or any information that can identify you will be used in this presentation or any reports about the study.

If you want to know more about how the information collected about you by a study is used, speak to the study team: they are there to support you and answer any questions.

I received a trial vaccine. Will it protect me against new variants?

This is an important question, but we will need further studies and evidence to give a firm answer. The Delta variant emerged recently, so most of the large clinical trials have not been designed to capture data on how vaccines protect against it. There are other studies going on, including laboratory tests and looking at ‘real world’ data, that is, information on people who become ill with different variants of Covid and which (if any) vaccines they received.

From the information available so far, there is no reason to have less confidence in the trial vaccines’ effectiveness against new variants than other vaccines that are currently approved. We are already planning new studies looking at booster vaccines targeted against new variants, and will keep you updated on this area over the coming months.

Safety

How safe are the COVID-19 vaccines being tested and have they been rushed?

The safety of volunteers is our highest priority. All medicines that we take, and all vaccines that we give, carry risks. The whole purpose of research is to minimise those risks. As with any medicine, vaccines are highly regulated products. There are checks in place at every stage in the development of a vaccine and that is not being compromised.

The Medicines and Healthcare products Regulatory Agency (MHRA), a globally leading regulatory agency, checks the safety, quality and effectiveness of all COVID-19 vaccines, and ensures no stage in the development process is skipped. Volunteers are carefully assessed before they take part, and are carefully monitored afterwards, with 24 / 7 access to doctors and nurses running the trial. This is so they can report anything they are concerned about or if they feel unwell for any reason.

We’re researching different types of vaccines against COVID-19. Some of these types of vaccines have been in use for a long time. This means we have a lot of experience and data on how they work, the immune responses they generate, and knowledge about their safety. In any trial, it isn’t the research that takes a long time, it’s the steps beforehand: for example funding and approvals. What’s being sped up in the whole trial process this time is the funding, not the actual undertaking of the studies. Each trial has an independent safety committee that keeps the study under active review, including any reports of side effects. They can take immediate action such as suspending the trial, if any problems are found.

This short animation helps to explain how vaccines for COVID-19 have been developed in a short space of time.

Can I take part in research if I have a pre-existing condition?

Please sign up to register your interest. Researchers will be looking for lots of different people to take part in their studies to make sure it works for everyone. A number of studies will be looking for healthy people with no pre-existing conditions. Some studies may be looking specifically for people of different ages with an existing condition or a suppressed immune system, as they may respond differently to a vaccine. In some studies, there will be certain people who cannot be enrolled at this time, such as people who are being treated for cancer, who are pregnant or breastfeeding, or who have certain immune conditions. However, increasingly there are studies that will be looking at people in these groups, when these can be safely trialled.

Registering with this service will allow researchers to contact you. When they do, they will discuss any pre-existing medical conditions you may have with you. You may also want to speak to your own health professional for further advice.

Will I be risking my health or those I live with if I take part in a vaccine study?

The vaccines themselves should not pose a risk to those you live with. If a household member is shielding and you are supporting them by staying at home to limit exposure to infection, then taking part in the vaccine study would require you to leave your home more frequently.

How do researchers make sure COVID-19 vaccines are safe to be tested on people like me?

Vaccines are tested in a number of stages to make sure they are both safe and effective. You may be invited to participate in a study that is evaluating whether the vaccine is safe to be used for other people like you.  

The information you are given about any study you are invited to take part in will explain what stage the vaccine is at and how it has already been tested. You can consider this information when deciding whether to take part.

Will the COVID-19 vaccine tested on me have been tested on other people before me?

The number of people the vaccine has been tested on will depend on the stage of the study. You should be told how many people have been tested before you decide to take part in a study. 

Will I need to self-isolate whilst I'm part of a vaccine study?

There is no need to routinely self-isolate if you are taking part in a vaccine study. After some vaccines, you may experience a fever for one or two days.  If this were to happen, then you may need to self-isolate depending on the current public health policy

Will I experience any illness or side effects as a result of a vaccine?

Common vaccine side effects include soreness, swelling and redness at the site of the vaccination and sometimes more general symptoms like tiredness, achy muscles and fever which may last for a few days and get better by themselves. The study team will give you further information about common side effects and how to manage them, and what to do if you experience any other side effects.

I understand that volunteers could be deliberately infected with coronavirus in order to test the effectiveness of the vaccine. Is this what is planned for those who have signed up the vaccine registry?

Taking part in human challenge trials is voluntary. In these trials, a few young, healthy volunteers may be exposed to small amounts of live virus after vaccination. Volunteers for any clinical trials only take part with their full consent, and all the facts of the trials are made available to them before they sign up. This ensures that volunteers do so with full knowledge of the facts and clinical risks.

I received a trial vaccine. Will it protect me against new variants?

This is an important question, but we will need further studies and evidence to give a firm answer. The Delta variant emerged recently, so most of the large clinical trials have not been designed to capture data on how vaccines protect against it. There are other studies going on, including laboratory tests and looking at ‘real world’ data, that is, information on people who become ill with different variants of Covid and which (if any) vaccines they received.

From the information available so far, there is no reason to have less confidence in the trial vaccines’ effectiveness against new variants than other vaccines that are currently approved. We are already planning new studies looking at booster vaccines targeted against new variants, and will keep you updated on this area over the coming months.

Participation

Would I have to tell others that I'm part of a vaccine study?

You do not have to tell family, friends or employers that you are part of a vaccine study. If you are admitted to hospital for any reason, we ask you to inform the staff caring for you. Please follow the study's instructions if you experience any symptoms of COVID or any unexpected side effects.

Will I be disadvantaged if I join a trial, and I'm invited to receive a licensed vaccine?

We don't want vaccine trial volunteers to be disadvantaged. When you are invited to receive an approved vaccine, the research team has a system to 'unblind' you and give you advice on whether to have a licensed vaccine as well as the trial vaccine.

Will taking part in the study affect my life/health insurance?

Joining a research study should not affect life or critical illness insurance cover that you already have. You don’t generally have to tell your insurer that you are taking part in a research study, or the results of any investigations found during the study.

This is because life insurance is long term and continues until either you cancel it or make a claim. It is always best to check the terms and conditions of your policy with your insurer. If you are taking out a new policy, most of the time, insurance companies will ask about your health and your medical treatment, but won't be worried about the fact you are taking part in a study. But if they ask, you need to tell them, and answer all questions as fully and accurately as you can.

Will taking part in the study affect my travel insurance?

No, not generally, as taking part in the COVID vaccine study does not increase your risks. But do speak to the study team if you have travel planned, as it may affect when appointments and tests are booked. When applying for travel insurance, insurers will ask questions about a person's health in order to make an accurate assessment. Customers should answer any questions in the insurance application to the best of their knowledge. The insurer will ask about any pre-existing health conditions and associated medical treatments.

Participation in a clinical trial is not something that would be expected to lead to increased premiums or insurance refusal as it does not carry increased risk above that associated with the condition under trial. So, whilst having a condition itself may attract additional costs to travel insurance, participation in the clinical trial should not result in any further costs or penalties.   

Should I still get a flu vaccination?

Yes, if this is recommended for you. You may need to wait between one to four weeks between receiving the flu vaccine and receiving any COVID vaccine, but you can still enroll in the study and discuss timing with the research team. Do not put off your flu vaccination to take part in the COVID trial, as it will give you important protection.

Can I take part in a trial if I've already tested positive for COVID-19?

Not generally. This is because you may have some immunity that means you are less likely to contract COVID, with or without a vaccine, and could sway the research findings. You can still sign up to take part in COVID and other healthcare research though. There are many other trials underway that you may be suitable for, including some on the long-term after effects on having had COVID. Find out more on the How to Get Involved section of the Be Part of Research website.

Please also come forward for an approved COVID vaccine when you are invited to, as long as it is 28 days since your positive COVID test.

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.