Stronger myocarditis warnings after death linked to vaccine

The likely death of a woman in her 20s from myocarditis following a COVID-19 vaccination has prompted changes to the Product Information of both mRNA vaccines.
 
The woman reportedly died a few weeks after receiving a booster dose of Moderna’s Spikevax vaccine.
 
A Therapeutic Goods Administration (TGA) safety report last month stated that a meeting of the external Vaccine Safety Investigation Group was called on 7 September ‘to provide further advice’ on the case.
 
It said the group included a panel of experts in cardiology and vaccines, along with a consumer representative and a community engagement expert.
 
‘The TGA extends its sincerest condolences to the family and loved ones of this young woman,’ the safety report stated.
 
‘After close consideration, the panel agreed that this woman’s myocarditis was likely to have been related to vaccination but acknowledged there were several other complicating factors that may have contributed to her death.’
 
It said the panel recommended the existing warning about myocarditis be strengthened in Product Information for both Pfizer and Moderna vaccines.
 
The case was also referred to the Australian Technical Advisory Group on Immunisation (ATAGI) ahead of an update to clinical guidance on myocarditis and pericarditis after COVID-19 vaccination.
 
‘As myocarditis is more commonly seen in males aged 12–30 years after a second vaccine dose, the expert panel noted there may be less awareness in the community that myocarditis can also occur in women and after a booster vaccine dose,’ the TGA reported.
 
‘This highlights the importance of informing patients, whether male or female, about the risk of myocarditis before receiving a vaccine dose and ensuring health professionals consider the possibility of myocarditis when patients present with new symptoms following vaccination.’
 
It is the first death in Australia that has been officially linked to an mRNA vaccine. The death is being reviewed by a state coroner.
 
The TGA says that the expert group stressed the overall benefits of vaccination ‘continue to far outweigh the risks for the mRNA vaccines’.
 
There have been 14 COVID-19 vaccine-related deaths reported since the rollout began early last year.
 
As of 12 October, a total of 63,807,197 vaccine doses had been administered in Australia since the rollout began last year.
 
The Department of Health has published detailed guidance on myocarditis and pericarditis after vaccination on its website.
 
The most recent updates to clinical guidance for COVID-19 vaccines can be found here.

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COVID-19 myocarditis TGA