TGA to stop reporting myocarditis
TGA to stop reporting myocarditis
Myocarditis is reported in around 2 in every 100,000 of those who receive Spikevax (Moderna).
As reporting rates of myocarditis and pericarditis following vaccination are very stable,
we will not include this section in future COVID-19 vaccine safety reports.
However, we continue to monitor and review these adverse effects and will communicate any updated safety advice if needed.
Primary course recommendations
COVID-19 vaccination is recommended for all people aged 5 years or older to protect against COVID-19.
For most people, a primary vaccination course consists of 2 doses.
Adverse reactions, TGA data
One adverse event report per 490 doses given, 0.2039%
In Western Australia
0.241%
10,428 adverse events (97%) occurred after a COVID-19 vaccine
21 times more common than ‘conventional’ vaccines
Swiss data
Myocardial Injury after COVID-19 mRNA-1273 Booster Vaccination
https://onlinelibrary.wiley.com/doi/epdf/10.1002/ejhf.2978
mRNA-1273 vaccine-associated myocardial injury was adjudicated in 22 participants (2.8%).
(N = 777 per group)
One in 35 recipients (2.8%) had vaccine-associated myocardial injury
Matched controls, elevated high-sensitivity cardiac troponin T concentration
Significantly higher in post vaccination group p<0.001
Thai study
Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9414075/
After BNT162b2, 2nd dose, Thai adolescents, aged 13–18 years,
n = 314
Seven participants (2.33%) exhibited at least one elevated cardiac biomarker
Myopericarditis was confirmed in one patient after vaccination.
Two patients had suspected pericarditis
Four patients had suspected subclinical myocarditis
Hence, adolescents receiving mRNA vaccines should be monitored for cardiovascular side effects.
Israeli study
A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons
https://pubmed.ncbi.nlm.nih.gov/36097844/
Incidence of myocardial injury after fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech)
N = 324
Reported vaccine-related adverse reactions
Chest pain in 12 (3.7%)
Palpitations in 7 (2.16%)
Vaccine-related myocardial injury in two (0.62%)
Post-COVID-19 vaccination
As of 23 November 2022,
following Pfizer/BioNTech
851 reports of myocarditis and
579 reports of pericarditis
Total of 1,430
Following Moderna vaccine
251 reports of myocarditis
149 reports of pericarditis
Total of 1,530
As of 23 November 2022,
myocarditis following monovalent Pfizer/BioNTech was 10 reports per million doses;
If there is a suspicion of myocarditis or pericarditis, initial investigations should be:
12 lead electrocardiogram (ECG)
inflammatory blood markers (C-reactive protein (CRP), full blood count (FBC) and erythrocyte sedimentation rate (ESR)
Troponin
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