She added that “in trying to convince people in positions of influence to pay attention to the risks of Long Covid and reinfection for people with vaccine injury, I have personally been met with obstruction and resistance to openly discuss this issue”.
“There has been a delay in recognition of vaccine injury, partly because of under-reporting, concerns about vaccine hesitancy in the context of managing a global pandemic, and needing to find the balance between risks and benefits on a population level,” she said.
“Reactions were said to be ‘rare’ without data to confirm how common or otherwise these reactions were. In general practice I was seeing cases, which meant other GPs and specialists were seeing cases too. Without diagnostic tests, we have to rely largely on clinical history.”
In July this year, the independent OzSAGE group of which Dr Phelps is a member issued a position statement calling for better systems and management of Covid vaccine adverse events and “recognition of the impact of vaccine injury”.
Dr Phelps, who was heavily involved in crafting the statement, wrote in her submission that the OzSAGE document “outlines the scope but not the scale of the problem because we do not know the scale of the problem”.
“This is partly because of under-reporting and under-recognition,” she said.
According to the TGA’s most recent safety update, there have been a total of 137,141 adverse event reports from nearly 64.4 million doses — a rate of 0.2 per cent.
There have been 819 reports “assessed as likely to be myocarditis” from 49.8 million doses of Pfizer and Moderna. Fourteen deaths have officially been linked to vaccination — 13 after AstraZeneca and one after Pfizer.
But Dr Phelps pointed to data from Germany’s pharmacovigilance body, the Paul Ehrlich Institute (PEI), which has “undertaken ongoing surveys of vaccine recipients … as opposed to the TGA which only accepts passive reports, or AusVaxSafety whose survey stopped at six weeks”.
“They have found that the incidence of serious reactions occurs in 0.3 per 1000 shots (not people),” she said.
“Considering that the majority of Australian adults have now had at least one booster, this suggests that the incidence of serious adverse reactions per vaccinated person could be more than 1-in-1000. PEI admits that under-reporting is a problem, and observers suggest that an order of magnitude of under-reporting is not unreasonable to consider (most estimates put underreporting at much worse than this).”
Dr Phelps said there was concern some adverse events could “cause long-term illness and disability”, but data was limited because the “global focus has been on vaccinating as many people as quickly as possible with a novel vaccine for a novel coronavirus”.
“Because of this, all of the studies that have been published so far are either small, or case studies only,” she said.
“The burden of proof seems to have been placed on the vaccine injured rather than the neutral scientific position of placing suspicion on the vaccine in the absence of any other cause and the temporal correlation with the administration of the vaccine.”
She noted some countries had gathered significant databases of adverse events, ranging from allergy and anaphylaxis to cardiovascular, neurological, haematological and auto-immune reactions.
Despite the recognition of heart inflammation associated with the Pfizer and Moderna mRNA vaccines, Dr Phelps said “even then, there has been a misconception that myocarditis is ‘mild’, ‘transient’ and ‘mostly in young males’, when there are many cases where myocarditis is manifestly not mild, not transient and not confined to the young male demographic”.
Dr Phelps said until there was acknowledgment and recognition of post-vaccination syndrome or vaccine injury, “there can be no progress in developing protocols for diagnosis and treatment and it is difficult to be included in research projects or treatment programs”.
“It has also meant a long and frustrating search for acknowledgment and an attempt at treatment for many individual patients,” she said.
“People who suffer Covid vaccine injury may present with a range of symptoms, and results of standard medical tests often come back normal. And like patients with Long Covid, they too are also asking the medical profession and public health systems for help.”
Earlier this year, Dr Rado Faletic — who previously spoke out about his battle with the TGA — launched Australian advocacy group Coverse to provide support and collect testimony from those suffering vaccine injuries.
The TGA said in a statement that people who submit adverse event reports “are not routinely given feedback about their adverse event report beyond the acknowledgement letter”.
“However, in some cases reporters are contacted if further information is required to either complete or assess the adverse event report,” a spokesman said.
“The TGA’s function is to analyse adverse event report data to look for potential conditions or adverse effects which may be linked to vaccination. The Product Information (PI) documents for Covid-19 vaccines include information on adverse events including the expected frequency, when known. The PI documents are available on the TGA website. The TGA also publishes information about adverse events in the Covid-19 vaccine safety report.”
AHPRA said in a statement that the regulator had “been clear in all of our guidance about Covid-19 vaccinations that we expect medical practitioners to use their professional judgement and the best available evidence in their practice”.
“This includes keeping up to date with public health advice from Commonwealth, state and territory authorities,” a spokeswoman said.
“Legitimate discussion and debate, based on science is appropriate and necessary to progress our understanding and knowledge. The [March 9, 2021 position] statement does not prevent practitioners from having these discussions.”
She added that as of June 2022, only 11 practitioners had been suspended “in relation to concerns raised about Covid-19”.
“The concerns raised about the practitioners related to the spreading of misinformation about Covid-19 or vaccination advice, including that the Covid-19 pandemic was fake, that the vaccination program was about government led mind control or in some instances representing that patients would develop cancer by having a vaccination administered,” she said.
Reached on Tuesday, Dr Phelps declined to comment further on the submission.
Dr Phelps, who remains a practising GP, was elected as the first female president of the AMA in 2000.
She was also a City of Sydney councillor from 2016 to 2021, and Deputy Lord Mayor under Clover Moore from 2016 to 2017.
In 2018, Dr Phelps ran as an independent candidate in the by-election for the eastern suburbs seat of Wentworth following the resignation of Prime Minister Malcolm Turnbull, defeating Liberal Dave Sharma.
