Australia’s drug regulator was slow to update the country’s Database of Adverse Event Notifications (DAEN) despite several deaths being attributed to the vaccine, including two children, aged 7 and 9.
The information came to light following a Freedom of Information request by an Australian doctor that found the delayed response from the Therapeutic Goods Administration (TGA).
Senator Gerard Rennick said he would push for independent oversight of the TGA.
“A third independent medical party should examine the evidence as the TGA has a conflict of interest because they approved the vaccines and would therefore be held responsible for the deaths of these children due to poor regulatory oversight,” Rennick told The Epoch Times.
The senator also said he was concerned that the TGA was soft-pedalling the risks with the COVID-19 vaccines, especially around myocarditis and cardiac arrests.
“They are definitely downplaying the risks. They do not have enough information to rule it out given the known link between the vaccines and myocarditis and myocarditis and cardiac arrests,” Rennick said.
The TGA states that they “rigorously assess any COVID-19 vaccine for safety, quality and effectiveness before it can be supplied in Australia.”
Currently, the TGA has granted provisional approval to VaxZeveria, Nuvaxovid, MVC COVID-19 vaccine, Cosmovaxx, and vaccines by Janssen, Moderna, and Pfizer.
“All COVID-19 vaccine applications are being treated with the greatest priority as part of the Department of Health and Aged Care’s response to the pandemic,” the TGA states.
“Under normal circumstances, the TGA’s assessment (for both provisional and full registration) begins once all information to support registration is available. For COVID-19 vaccines, the TGA has agreed to accept rolling data to enable early evaluation of data as it comes to hand using the provisional pathway.”
As of March 6, the DAEN states that since the beginning of the vaccination rollout in Australia, 137,576 adverse events have been reported relating to the range of COVID-19 vaccines. Of those, 134,224 are believed to be directly related to the vaccines, while 980 are vaccine-related deaths.
What the Vaccine Safety Investigation Group Does
The TGA does have a pre-existing independent review vehicle for vaccines called the Vaccine Safety Investigation Group (VSIG).
The group is meant to provide independent expertise to assist the TGA in investigating and managing Adverse Event Following Immunisation (AEFI) cases.
The group is described as a time-limited working group of experts that can be convened when a single serious AEFI—that is unexpected and without an obvious non-vaccine cause—occurs. The TGA notes that an AEFI is considered unexpected when it is not listed in the product information document for a drug, or when causality cannot be established.
Alternatively, the group can be established when a serious AEFI results in death, is life-threatening, requires inpatient or prolonged hospitalisation, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
It can also be established when an AEFI is above an expected rate or level of severity, or there is a cluster of AEFIs that are serious or could be due to administration or quality issues. A cluster is considered to be two or more cases of the same or similar events related in time, geography, and/or vaccine administered.
Despite the 100,000 plus adverse events recorded, according to the TGA’s website, the VSIG has been convened only a couple of times during the pandemic.
One instance occurred on Jan. 21, 2022, to discuss two fatal cases of suspected thrombosis with thrombocytopenia following a second dose of the AstraZeneca vaccine.
“Both cases were complex and involved patients with underlying conditions that could have caused their symptoms. After extensive deliberation, the panel concluded there was not sufficient evidence to link either case to vaccination,” the TGA said.
TGA Head Defends Agency’s Record
The deputy secretary of Health Products Regulation Group, Prof. John Skerritt, defended the TGA’s decision to recommend the vaccines in a Senate Estimates hearing in February.
He said that while the TGA acknowledged and apologised for the pain and distress of those seriously injured from the vaccines, those reactions were rare.
“I have actually apologised on national television, together with former Minister Hunt, when the first death—the first sad death was a lady from the Central Coast. We apologised in writing for what were weekly and are now fortnightly vaccine safety reports.
“So we put out detailed public reports—as well as doing media—on vaccine safety, and, in those, we acknowledged the pain and distress of those who had been seriously injured, but we also emphasised the extreme rarity of these conditions,” he said.
He noted that all modern medicine comes with a set of associated risks, adding that many other common medicines have a higher rate of injury and death than the COVID-19 vaccines.
“We have modern medicines, and every medicine has risks as well as benefits,” Skerritt said. “By way of indication: since the beginning of the COVID pandemic, more than 10 times as many people have died from paracetamol, from Panadol, as from adverse events due to COVID vaccines.”
According to the DAEN website, since 2020, adverse events attributed to Panadol number 99; of those adverse events, 58 are believed to be directly tied to the medicine with four reported deaths.
The DAEN website also notes that since 1971, there have been 1,002 adverse events related to Panadol, with 38 deaths.
Doctors Hands Are Tied
Meanwhile, an Australian doctor who spoke to The Epoch Times on condition of anonymity, said they knew of hundreds of Australians suffering adverse reactions.
“I know of literally hundreds who are suffering from adverse events; they have had their WorkCover or government compensation claims declined and have been left with disabling injuries,” the doctor said.
“As doctors, we really do not know how to treat these adverse events; there is limited information and limited collaboration because overall there is some reluctance to discuss these events and for some doctors even to admit they are happening.”