Important information for patients and the public
Thank you for your interest in COVID-19 vaccine research.
You may have heard the encouraging interim results of clinical trials into COVID-19 from Pfizer/BioNTech and also Moderna.
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 potential vaccines.
Although these are significant steps forward, the vaccines have not yet been approved for use in the UK yet and clinical trials into a number of other COVID-19 vaccines will 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.
There are no changes to current clinical trials at the moment. As soon as a vaccine is approved and rolled out for use in the NHS, we will have a process to make sure people on the clinical trial are not disadvantaged.
This will mean being able to have an effective vaccination through the NHS (who will call people up in an agreed priority order), if they haven’t already had one through the study.
In the meantime, participants should continue to attend their trial appointments in the normal way, receive booster injections and report safety data.
Yes. There is no change to any of the number of clinical trials into COVID vaccines at the moment, and it is essential that these continue. We will need data about a number of vaccines and their safety and effectiveness, in order to protect the population. No one vaccine is likely to be suitable for everyone, the first vaccine may not be the most effective and easiest to use, and we must make sure that the other studies continue to allow us to have a selection of vaccines to protect the whole population.
I’m on a clinical trial and in a priority group for vaccination, how will I be offered early protection?
When an approved vaccine is available (called ‘deployment’), people in priority groups will be contacted by the NHS and offered an appointment to receive it.
These priority groups are likely to include people who live in care homes, people aged over 80, and some front line health and care workers. If you are invited to a vaccine, at this stage, 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. People will be called up by the NHS to be offered a vaccine in a priority order determined by experts, based on how at risk they are of becoming ill with or spreading severe infection.
It is likely to take some time for healthy people under 50 years of age to be invited to receive an approved vaccine, which could mean many months. We are asking people to continue to take part in clinical research for as long as possible.
What if I want to leave the clinical trial as a result of the information about the other effective vaccines?
People on the trial are free to leave at any time, and this is a personal choice. However, it is important to note that leaving the trial will not offer you any further protection, as it will not affect when you can receive an approved vaccine.
People taking part in the trial will still be able to receive an approved vaccine without delay when they are called up by the NHS. We are also only able to respond to unblinding requests at the end of the trial or for a medical reason, according to agreed protocols that set out how the trial is run.
We ask that people continue to attend appointments, receive booster doses and share data on their health and infection with COVID for as long as possible, so that the trials can complete as early as possible.
It’s a personal choice but we believe it is. A vaccine is not yet approved, and is unlikely to be available to many people until well into the new year. Once a vaccine is available, we will have a process in place so people on the study are not disadvantaged.
You can still have an approved vaccine when this is available, even if you take part in a study. 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.