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The MHRA has undertaken a thorough review of both UK and international reports of suspected myocarditis and pericarditis following vaccination against COVID-19. There has been a consistent pattern of higher reporting of these suspected events with both the monovalent COVID-19 Vaccine Pfizer/BioNTech and COVID-19 Vaccine Moderna, and of these occurring more frequently in males. These reports have also been analysed by the government’s independent advisory body, the CHM and its COVID-19 Vaccines Benefit Risk Expert Working Group. Following their advice, the product information for both monovalent COVID-19 Vaccine Moderna and COVID-19 Vaccine Pfizer/BioNTech was updated to inform healthcare professionals and patients of these reports and provide advice to be aware of important symptoms for myocarditis and pericarditis. This advice has also been included in the product information for the bivalent (original/Omicron BA.1) COVID-19 vaccines for Moderna and Pfizer/BioNTech.
The social media campaign calls upon healthcare professionals, national immunisation programme staff, as well as patients, their carers and families, to report suspected side effects from medicines or vaccines using the Yellow Card scheme. This #MedSafetyWeek is the sixth annual awareness week involving medicine regulators from over 60 countries. It focuses on the importance of reporting suspected side effects following vaccination and the MHRA is taking part to further encourage everyone to report. For the Autumn 2022 COVID-19 vaccination booster campaign, the bivalent COVID-19 Pfizer/BioNTech booster vaccine (Comirnaty Original/Omicron BA.1) and the bivalent COVID-19 Moderna booster vaccine (Spikevax bivalent Original/Omicron) are mainly being used. The original monovalent Pfizer-BioNTech vaccine is recommended for eligible persons aged 5-11 years while the COVID-19 vaccine Novavax (Nuvaxovid) is recommended for those who cannot receive an mRNA vaccine. Magnus, MC et al. Covid-19 Vaccination during Pregnancy and First-Trimester Miscarriage N Engl J Med 2021; 385:2008-2010 DOI: 10.1056/NEJMc2114466: https://www.nejm.org/doi/10.1056/NEJMc2114466 ↩ The eighth annual #MedSafetyWeek campaign has today (6 November 2023) been launched by the Medicines and Healthcare products Regulatory Agency (MHRA). Part of a global campaign involving 88 countries, the initiative runs from 6-12 November and aims to improve patient safety by encouraging reporting of any suspected side effects from medicines and adverse incidents associated with medical devices. The MHRA has received 30 UK reports of suspected ADRs with a fatal outcome to the bivalent COVID-19 Pfizer/BioNTech vaccine and 42 reports of suspected ADRs with a fatal outcome for the bivalent COVID-19 vaccine Moderna. The MHRA has received no UK reports with a fatal outcome for COVID-19 Vaccine Novavax.Bootstrap’s cards provide a flexible and extensible content container with multiple variants and options. About Every report counts and is important so if in doubt about reporting a suspected issue, the advice is to please report it as Yellow Card reports can help prevent future harm to others. Robust safety monitoring and surveillance of any COVID-19 vaccines used in the UK will continue along with timely communication on any updated safety advice when needed. Additionally, monthly updates of Adverse Drug Reaction (ADR) data will continue with the new interactive COVID-19 vaccine reports. Clinical Practice Research Datalink (CPRD) is a real-world research service to support public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care. CPRD collects anonymised patient data from a network of GP practices across the UK. Commission on Human Medicines (CHM)
With this year’s theme being ‘Who can report?’, the campaign focuses on the key role that every patient, carer and healthcare professional has in reporting suspected side effects and adverse incidents with medical devices, and the positive impact this can have on patient safety. You don’t have to prove that the healthcare product caused the side effect or incident - just a suspicion is enough for you to submit a report. Put down the necessary cards and if you don’t have any card in your hand that can be played, you must draw a card from the draw pile. If that card can be played, you have the choice of whether or not to put it down on the discard pile. Vaccination data are not always reported weekly and can be updated for historical dates when vaccinations are recorded on the relevant system, therefore the data may be incomplete, and the resulting estimates are approximate. The estimated number of doses administered differs from the estimated number of people vaccinated due to the different data sources used. Table 1: Number of people who have received at least one third or booster dose of a vaccine for COVID-19 in the UK between 8 December 2020 and 22 February 2023 [footnote 1] Country
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Northern Ireland ( The Northern Ireland Statistics and Research Agency): In the week ending 17 February 2023, 402 deaths were registered; of these deaths, 12 cited COVID-19, accounting for 3.0% of all deaths. This year’s campaign consists of an international collaboration involving 100 organisations spanning across 88 countries that operate their own national patient safety monitoring systems like the MHRA Yellow Card scheme. The purpose of safety monitoring is to gain information about new side effects and adverse incidents, to find out more about known ones, and, most importantly, to ensure the safest use of medicines and medical devices. It is important that everyone submits a report to the Yellow Card scheme as soon as they suspect a side effect from a medicine or adverse incident associated with a medical device. This ensures that actions to reduce harm are based on the best available evidence and can improve safety for as many people as possible. If identified, information on new and emerging safety concerns will be provided together with details of any resulting regulatory action or changes to advice on the use of the vaccines. Yellow Card reports Vaccine doses administered in the Autumn 2022 booster campaign
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