Other safety alerts
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| The United Kingdom: COVID-19 vaccines: Review of extremely rare reports of myocarditis and pericarditis |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that revisions have been made to the information for healthcare professionals and information for United Kingdom vaccine recipients for the COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine following a thorough review of extremely rare reports of myocarditis and pericarditis after COVID-19 vaccination. These events are extremely rare and tend to be mild when they do occur. The MHRA’s advice remains that the benefits of getting vaccinated outweigh the risks in the majority of people.
The MHRA and the Government’s independent expert advisory body, the Commission on Human Medicines (CHM), has conducted a thorough review of suspected adverse reaction reports of myocarditis and pericarditis following COVID-19 vaccination. The CHM has carefully considered the available data and has advised that healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinated individuals should be advised to seek immediate medical attention should they experience new onset of chest pain, shortness of breath or symptoms of arrhythmia. On 25 Jun 2021, revisions were made to the product information for COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine.
As of 23 Jun 2021, the MHRA has received 60 Yellow Card reports of myocarditis and 42 reports of pericarditis following use of the Pfizer/BioNTech vaccine, as well as one report each of viral pericarditis and Streptococcal endocarditis. There have been 5 reports of myocarditis and 2 reports of pericarditis following use of COVID-19 Vaccine Moderna up to the same date. As of 23 Jun 2021, an estimated 18 million first doses and around 11 million doses of the Pfizer/BioNTech vaccine had been administered. An approximate 0.88 million first doses of the COVID-19 Vaccine Moderna have also now been administered.
There has also been reporting of similar cases internationally following receipt of the Pfizer/BioNTech and Moderna vaccines. These have occurred most frequently in younger men aged 40 years and younger and within 10 days after the second dose. Most of these cases were mild and individuals typically recovered within a short time and with symptomatic treatment and rest. While reports of myocarditis and pericarditis after vaccination with COVID-19 vaccine AstraZeneca have also been received, there is insufficient evidence to recommend similar warnings for this vaccine.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Confirmation of diagnosis of these conditions typically requires targeted diagnostic procedures, such as electrocardiograms, cardiac imaging, and biomarker analysis, and it is also important to exclude other potential causes for the symptoms. Treatment of more symptomatic patients will occasionally require relevant expert follow up that might need detailed cardiac imaging to determine the nature of the condition.
Vaccinated individuals should be advised to seek immediate medical attention should they experience new onset of chest pain, shortness of breath, or symptoms of disturbance of cardiac rhythm.
Advice for healthcare professionals:
- There have been extremely rare reports of myocarditis and pericarditis occurring after vaccination with COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine.
- Cases occurred most frequently in younger men and shortly after the second dose of the vaccine.
- These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest.
- Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis.
- Vaccinated individuals should also seek immediate medical attention should they experience new onset of chest pain, shortness of breath, palpitations or arrhythmias.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/covid-19-vaccines-updates-for-july-2021
In Hong Kong, the above products are not registered pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138). The COVID-19 vaccine by Fosun Pharma/BioNTech (i.e. Comirnaty) is authorised for emergency use in Hong Kong in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K). Related news was previously issued by European Medicines Agency, the United States Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 12 Jun 2021, 26 Jun 2021 and 2 Jul 2021. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 28 Jun 2021. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Thursday, Jul 8, 2021
Issued at HKT 17:00
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