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.

https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-13-07-2023#myocarditis-and-pericarditis-after-covid19-vaccination

https://www.outkick.com/silent-killer-australia-to-stop-reporting-on-myocarditis-cases-related-to-covid-vaccine/

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

https://www.health.wa.gov.au/~/media/Corp/Documents/Health-for/Immunisation/Western-Australia-Vaccine-Safety-Surveillance-Annual-Report-2021.pdf

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%)

https://www.gov.uk/government/publications/myocarditis-and-pericarditis-after-covid-19-vaccination/myocarditis-and-pericarditis-after-covid-19-vaccination-guidance-for-healthcare-professionals

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