Australia has suffered its first death from myocarditis associated with an mRNA based COVID booster shot.
An external expert Vaccine Safety Investigation Group (VSIG) was convened by the TGA on 7 September 2022, to provide further advice on the case of a young woman in her 20s who died a few weeks after receiving a booster dose of Moderna’s Spikevax vaccine.
The VSIG included specialists in cardiology and vaccines, as well as a consumer representative and community engagement expert, and was asked to consider whether any additional advice to the public and healthcare professionals was required.
Given the available information, including the absence of other apparent causes of the myocarditis, and the timeframe for the onset of symptoms, the panel agreed with the TGA’s assessment that the myocarditis the woman experienced was likely to have been related to vaccination.
However, the panel acknowledged there were several other complicating factors that may have contributed to her death, with the circumstances and potential causes that leading up to the event officially investigated by a state coroner.
“The TGA extends its sincerest condolences to the family and loved ones of this young woman,” the authority said.
“Myocarditis is a known risk associated with the mRNA vaccines. It is rare, particularly after a booster dose, and when it does occur cases are generally mild and resolves after a few days with treatment and rest.
“A small number of serious cases have been reported in Australia and overseas [yet] current evidence tells us at a population level, the risk of myocarditis and other heart problems after COVID infection is higher than after vaccination.”
Given this, the VSIG reaffirmed that overall, the benefits of vaccination at a population level continue to far outweigh the risks for the mRNA vaccines.
However, they also confirmed that serious cases of myocarditis have occurred, and the TGA has recommended that the existing warning about myocarditis be strengthened in the prescribing information for Pfizer’s Comirnaty and Moderna’s Spikevax
The expert group has also referred this case to the Australian Technical Advisory Group on Immunisation (ATAGI) who are publishing an update to clinical guidance for healthcare professionals on myocarditis and pericarditis after COVID 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 VSIG said.
“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.”
The TGA has closely reviewed all deaths reported in the days and weeks after COVID vaccination, and since the beginning of the vaccine rollout to 18 September 2022, some 63.3 million doses of COVID vaccines have been administered to Australians.
From the 939 reports received and reviewed, only 14 reports were identified where the cause of death was linked to vaccination and as previously reported, 13 of these deaths occurred after the first dose of AstraZeneca’s Vaxzevria: 0.8 were associated with thrombocytopenia syndrome (TTS) cases, two were linked to Guillain-Barre syndrome, two related to very rare conditions involving the nervous system, and one was a case of immune thrombocytopenia.
The 14 deaths occurred in people aged 21 – 81 years old and to date, there have been no deaths in children or adolescents determined to be linked to COVID vaccines in Australia.
“Vaccines can lead to death in extremely rare instances. However, most deaths that occur after vaccination are not caused by the vaccine,” the TGA explained.
“In large populations in which a new vaccine is given, there are people with underlying diseases who may die from these diseases. When a vaccine is given in that same population, the link between the vaccine and death is usually coincidental – not caused by the vaccine.
“These deaths are carefully reviewed for whether vaccines could be the cause and for the vast majority that is not the case.”