TGA releases vaccine-related myocarditis severity details

Only nine people with likely myocarditis or pericarditis associated with COVID-19 vaccination have been treated in Australian intensive care units, according to the Therapeutic Goods Administration (TGA).
 
The number represents less than 1% of all likely cases, while most of the approximately 700 patients admitted to hospital were reportedly discharged within four days.
 
Overall, 1399 people have been identified as having vaccine-linked suspected myocarditis since the COVID-19 vaccine rollout began, equivalent to three cases per 100,000 doses (0.003%). It also means that only 1.6 people have been hospitalised for every 100,000 doses, while for every five million doses, one person has ended up in intensive care.
 
No one has died as a result of vaccine-related myocarditis or pericarditis in Australia.
 
Conversely, at the time of publication 6526 people had died due to COVID-19 in Australia, at a rate of 130 deaths per 100,000 known cases.
 
The local experience with mRNA vaccines is similar to that of other comparable countries, such as the US, insofar as the highest rates of suspected myocarditis and pericarditis hospitalisations and cases have occurred in males under 30 years of age.
 
According to the TGA, in the majority of cases symptoms had resolved by the time patients were discharged and the most common treatment for these individuals was nonsteroidal anti-inflammatory drugs, such as ibuprofen.
 
‘Evidence from a US surveillance survey of patients who had myocarditis following vaccination indicates that most patients fully recover without lasting impacts on their quality of life or ability to work,’ the most recent TGA COVID-19 vaccine safety report states.
 
‘The survey, which was conducted three months after the initial myocarditis diagnosis, involved mostly men under 30 years after their second vaccine dose.
 
‘There were no deaths from myocarditis reported in these patients.’
 
The highest rates of vaccine-linked myocarditis in Australia are still among boys aged 12–17 who have received the Moderna vaccine (20 cases per 100,000 second doses), closely followed by men aged 18–29 who received the same vaccine (17.8 cases per 100,000 second doses).
 
To date, the youngest case classified as ‘likely myocarditis’ was nine years old.
 
Novavax
For the first time, the TGA has confirmed receiving a small number of reports of suspected myocarditis and/or pericarditis in people who have received the Novavax vaccine.
 
However, after assessing these cases against a set of internationally accepted criteria, none were deemed likely to represent myocarditis, while only four were likely to represent pericarditis.
 
Moreover, the TGA has not identified a safety signal that would indicate an association between Novavax and either condition.
 
The most commonly reported reactions to Novavax, according to AusVaxSafety survey, are fatigue, injection-site reactions and headache, which are ‘expected side effects’ that were also seen in clinical trials.
 
There have been 424 reports of suspected adverse events from about 97,800 Novavax doses administered in Australia up until 3 April, the TGA said. The most commonly reported reactions include headache, chest pain, paraesthesia (skin tingling), fatigue and dizziness.
 
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COVID-19 Moderna mRNA myocarditis Novavax pericarditis Pfizer vaccination