COVID-19 vaccines: updates for July 2021
Revisions have been made to the information for healthcare professionals and information for UK 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. Our advice remains that the benefits of getting vaccinated outweigh the risks in the majority of people.
Review of extremely rare reports of myocarditis and pericarditis
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 Friday 25 June, revisions were made to the product information for COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine, and the MHRA sent a notification to NHS contacts and healthcare stakeholders.
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
- all suspected adverse reactions associated with COVID-19 vaccines should be reported to the MHRA through the MHRA’s Coronavirus Yellow Card reporting site
Further information on reports of myocarditis and pericarditis
As of 23 June 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 June 2021, an estimated 18 million first doses and around 11 second 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.
Advice for the public
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.
The COVID-19 vaccines remain highly effective in protecting people from COVID-19 and have already saved thousands of lives. These events are extremely rare and tend to be mild when they do occur. Our advice remains that the benefits of getting vaccinated outweigh the risks in the majority of people. It is still vitally important that people come forward for their first and second vaccination when invited to do so, unless advised otherwise.
Summaries of Yellow Card reporting and other recent MHRA publications
We continue to publish the summaries of the Yellow Card reporting for the COVID-19 vaccines being used in the UK. The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
We have also recently:
- published the Public Assessment Report (PAR) and updated the Decision page on our website to provide more details about the COVID-19 Vaccine Janssen
- issued a conditional marketing authorisation for the COVID-19 Vaccine AstraZeneca, with corresponding Summary of Product Characteristics, Patient Information Leaflet, Conditions of Authorisation, Information for healthcare professionals and for UK recipients documents
We previously included summaries of latest COVID-19 information, including in the April 2021, May 2021, and June 2021 issues of Drug Safety Update. See guidance on COVID-19 for all our latest information, including after publication of this article.
Reporting Yellow Cards
Suspected adverse reactions associated with COVID-19 vaccines should be reported to the MHRA through the MHRA’s Coronavirus Yellow Card reporting site or via the Yellow Card app.
As these products are under additional monitoring this includes all suspected ADRs associated with these vaccines. This will allow quick identification of new safety information.
When reporting please provide as much information as possible, including information about medical history, any concomitant medications, onset, treatment dates, and vaccine product brand name and batch number.
You may be contacted following submission of a Yellow Card report so that we can gather additional relevant information for the assessment of the report. These contributions form an important part of our understanding of suspected adverse events.
Article citation: Drug Safety Update volume 14, issue 12: July 2021: 4.