Action – Read & Share: Is myocarditis a mild side effect?
Is myocarditis a “rare and generally mild” side effect of the Pfizer vaccine as stated on the Therapeutic Goods Administration website?
Summary
- A recent report into cardiac adverse events (CAE), found post-vaccination CAE rates following dose two of 162.2 and 94.0/million for boys 12-15 and 16-17, respectively. For boys with no underlying health conditions, the chance of either CAE, or hospitalization for CAE, after their second dose of mRNA vaccination are considerably higher than their 120-day risk of COVID-19 hospitalization, even at times of peak disease prevalence. The long-term consequences of this vaccine-associated cardiac inflammation are not yet fully defined and should be studied
(Høeg, Krug, Stevenson, & Mandrola, 2021). - The TGA updated its Product Information relating to Pfizer COMIRNATY vaccine to include safety related information on myocarditis and pericarditis: “The benefits of protection against COVID-19 far outweigh the risks from rare and generally mild side effects”. July 23 rd 2021 (Commonwealth of Australia, 2021)
- The Myocarditis Foundation states:
- “While this condition is uncommon, it can have serious consequences.”
- “Myocarditis and the resulting disorder of idiopathic dilated cardiomyopathy are the cause of approximately 45% of heart transplants in the U.S.”.
- “Approximately 5 to 20% of all cases of sudden death in young adults are due to myocarditis. There are many causes, including viral infections, autoimmune diseases, environmental toxins, and adverse reactions to medications”.
- Myocarditis is “poorly understood” and is an “often undiagnosed illness which can rapidly progress to heart failure and death.”
(Myocarditis Foundation, 2021)
- In the case of viral myocarditis: “Depending on the cause and extent of myocardial damage, the mortality rate is up to 20% at 1 year and 50% at 5 years. Despite optimal medical management, overall mortality has not changed in the last 30 years.” (NCBI, 2021)
Issues
The Myocarditis Foundation indicates that myocarditis can be fatal but the TGA’s Product Information for the Pfizer COMIRNATY vaccine states that myocarditis is “generally mild”.
- Considering that myocarditis is acknowledged as “poorly understood” and “often undiagnosed” by the Myocarditis Foundation, how is the TGA ensuring all adverse events following vaccination that result in myocarditis are being recorded and investigated?
- What evidence has the TGA used to conclude that myocarditis is a “rare and generally mild side effect”?
- Can the TGA definitively tell parents and young people that the risk of developing myocarditis from the vaccine is lower than from contracting Covid-19 itself?
Our recommended contact list contains State and Federal MP’s, Premiers, Chief Health Officers, TGA, Australian Medical Association and Australian Nursing and Midwifery Association.
We also request that you forward this Bulletin to as many people as possible so that they can do the same. We understand that these topics are highly emotive, but we request that you remain civil in all correspondence.
References
Høeg, T., Krug, A., Stevenson, J., & Mandrola, J. (2021, September 8). SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. Retrieved from MedRxiv: https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.full.pdf?fbclid=IwAR2WrI4T8j5IBc7yOnPtYULNfakVeNqkyIvYGJKLmFAGiUAYnqDUzlFmOgs
Commonwealth of Australia. (2021, September ). Pfizer COVID-19 vaccine (COMIRNATY) – Addition of safety information about myocarditis and pericarditis to Product Information. Retrieved from Department of Health Therapeutic Goods Administration:
https://www.tga.gov.au/media-release/pfizer-covid-19-vaccine-comirnaty-addition-safety-information-about-myocarditis-and-pericarditis-product-information
Myocarditis Foundation. (2021, March). Myocarditis and Giant Cell Myocarditis. Texas: Myocarditis Foundation.
https://www.myocarditisfoundation.org/wp-content/uploads/2021/03/Myocarditis-and-Giant-Cell-Myocarditis-2021.pdf
U.S. Department of Health and Human Services CDCP. (2021, August 06). COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years. Morbidity and Mortality Weekly Report, 70(31), pp. 1053-1058.
https://www.ncbi.nlm.nih.gov/books/NBK459259/
