The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to continually strengthening the Yellow Card scheme to support patient safety. The MHRA regularly promotes awareness through public health campaigns, conferences, established networks, and new educational resources available on the Yellow Card website. Further information is available on the MHRA website at the following link:

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Reporting rates through spontaneous reporting systems, such as the Yellow Card Scheme, are highly variable, and dependent not just on the condition, but other factors such as the product, public interest, and media attention. As such, the MHRA does not hold estimates of under reporting rates for these conditions.

The MHRA is expanding and improving digital reporting routes. Every National Health Service webpage relating to a medicine or vaccine now links to the Yellow Card scheme, and the MHRA is working with NHS colleagues to enhance integration with the NHS App to increase visibility and reporting by the public. Yellow Card reporting is now embedded in almost all general practice clinical IT systems, enabling healthcare professionals to submit reports directly on behalf of patients.

Over recent years, the MHRA has delivered a major upgrade programme to modernise the Yellow Card scheme’s technology and infrastructure. This includes improving the quality and timeliness of submitted information, making it easier to report, adding conditional questions to reduce follow up, and support real time signal detection of safety issues.

The Yellow Card app has also been modernised to mirror the website, broaden reporting options, including defective and counterfeit medicines, and improve access to safety data. Multifactor authentication has been introduced to enhance account security and enable future integration with the NHS login. The app has also been upgraded to a progressive web application, providing a seamless and engaging user experience across devices.

Together, these improvements increase public awareness, make reporting, including of myocarditis and pericarditis, easier, and enhance the MHRA’s ability to identify and assess emerging safety concerns across healthcare products.

Data on an individual’s complete vaccination record is held by their general practitioner. Although recent vaccinations may be identified and recorded within individual patient hospital records upon presentation and diagnosis with myocarditis or pericarditis, there is no single data platform available to systematically identify patients presenting with these conditions in a time period following any vaccination.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for monitoring the safety of all vaccines authorised in the United Kingdom. One of the sources of safety information is reports received through the Yellow Card scheme, which collects and monitors information on suspected side effects following any medicinal product or device.

Since January 2020 MHRA has received 1217 Yellow Card reports of myocarditis, 161 Yellow Card reports of myopericarditis and 979 Yellow Card reports of pericarditis following receipt of a vaccine. It is important to note that a Yellow Card report does not necessarily mean the vaccine caused that reported events.

The following table shows the number of primary diagnoses and admissions cases for myocarditis and pericarditis in each year from 2018 to 2021. However, this does not represent the number of patients, as a person may have more than one admission within the period.

Source: NHS Digital

Any assessment of the potential effectiveness of the blood test being developed by the British Heart Foundation and Queen Mary University would be made by the National Institute of Health and Care Excellence.

This information is not held in the format requested.

The UK Health Security Agency’s COVID-19 vaccination consent form for children and young people or parents and carers is part of a suite of materials, including an easy to read patient information leaflet, to assist an individual in making their decision about acceptance of vaccination. There are no plans to include information on the potential risks of the vaccine in the consent form, as this is available in the accompanying easy-read leaflet and importance is placed on making the consent form as accessible as possible.

The Medicines and Healthcare products Regulatory Agency (MHRA) does not hold information concerning the efficacy of anakinra for patients diagnosed with idiopathic recurrent pericarditis.

Kineret, containing the active substance anakinra, was approved by the European Medicines Agency (EMA) in 2002 for the treatment of rheumatoid arthritis in adults. The licence was extended to include treatment of Cryopyrin-Associated Periodic Syndromes. Anakinra is not licensed to treat idiopathic recurrent pericarditis.

The EMA is required to issue an opinion on applications for new indications within 90 days of receipt of a valid application. This period will be extended if it needs to request supplementary information from the applicant. The applicant will be requested to provide supplementary information within one month, although this may be extended to two months. The assessment of any supplementary information by EMA should be completed within 60 days. The European Commission is required to amend the marketing authorisation within two months of the EMA opinion.

The MHRA does not hold information on average and longest time for approval of variations by EMA.