As you will be receiving a vaccination for COVID-19 soon, or have already received one, we would like to ask for your help to increase our knowledge on the vaccine safety profile. Before a vaccine is used widely it undergoes robust clinical trial testing to ensure the vaccine is effective and safe to use. A vaccine will then be licenced and given to a larger, and more diverse group of patients, and at this stage we can still learn more about how the vaccine benefits patients, as well as any possible side effects. To help us gather this, we would like to ask you to participate to collect information about your experience.
Who are we?
We are the Medicines and Healthcare products Regulatory Agency (MHRA), and we regulate medicines, medical devices and blood components in the UK. This remit includes ensuring that these products, including vaccines, meet high standards of safety, quality and efficacy.
We already run a scheme, called the Yellow Card scheme, which collects information from patients and healthcare professionals about suspected side effects and incidents to products. This scheme has been in place since 1964 and has played an important role in building confidence on the safety of vaccines, as well as in the detection of unrecognised side effects. Further information on the Yellow Card scheme can be found here.
The Yellow Card scheme will continue to operate as normal, however we want to collect more information, more rapidly for new COVID-19 vaccines and so we are conducting a proactive data collection to collect information from recipients of the vaccine, such as yourself; this is system is called the Yellow Card Vaccine Monitor.
Why are we collecting this data?
We will be collecting information from patients in the weeks and months after their vaccination to see if they experience any side effects or are diagnosed with COVID-19. This data will be used to build our knowledge on the safety profile of new COVID-19 vaccines.
During clinical trials, some patient groups are excluded on ethical grounds, such as pregnant women or those with a weakened immune system. However, once a vaccine is licenced they can be given to these groups and so it is important that we collect information for these patient populations as soon as we can.
The data we collect will be analysed to help us to take regulatory decisions to ensure COVID-19 vaccines are used as safely as possible.
This data collection will be conducted by the MHRA. Results from this will be shared in collaboration with the MHRA Vaccine Expert Working Group, the Joint Committee on Vaccination and Immunisation and the Department of Health and Social Care.
Why am I being asked to participate?
As an early recipient of the vaccine, you may be part of a patient population that was excluded in clinical trials. Early recipients will also include patient populations included in clinical trials but on a greater scale and with a greater diversity of patients. As such, each recipient of a COVID-19 vaccine provides a valuable opportunity to collect information on the vaccine safety profile.
We are asking early recipients to support this so we can collect information as soon as possible.
What will you do with my data?
We will analyse the data to ensure that the benefits of the vaccines outweigh any potential risks.
Once you have familiarised yourself with the details of this data collection, if you are happy to contribute, please select the ‘Agree’ button at the bottom of this page. You will then be asked to register, which will include providing details about your medical history, including any medicines you are taking and any current or previous medical conditions.
Once you have received the vaccine, we will ask you to provide us with the vaccine name and batch number, which should be provided to you by your vaccination nurse. Please then enter this information into your profile.
After this, we will contact you via your preferred method (SMS, email or push notification) to ask you to let us know if anything has changed to your current circumstances, such as if you have taken any new medicines, had any symptoms you believe are related to the vaccine or if you have been diagnosed with COVID-19. We will ask you for this information more regularly to begin with and continue to follow up until X years after the vaccine.
If you would like to update your information with us outside of these time frames you can also do so via the App or website.
What happens if I have suspected side effects?
All vaccines carry a risk of side effects, however the most symptoms tend to be short term and mild, such as redness at the vaccination site.
If you are worried about a suspected side-effect and need medical advice, please contact a doctor or pharmacist, telephone NHS 111 in England and Scotland on 111 (textphone 18001 111) or NHS Direct Wales/Galw IECHYD Cymru on 0845 46 47 (textphone 0845 606 46 47).
What will happen if I don’t want to carry on with the data collection?
Participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason. You can opt out by updating your communication preferences.
As your data contains safety information related to COVID-19 vaccines, if you do opt out we will remove your patient identifying details from our database however we will store your anonymised data. Further information on right to erasure can be found here and in the privacy statement.
We hope you will be able to support us.
Your sincerely, Yellow Card team