An Australian senator has said he is concerned about the country’s therapeutic authorities’ delayed approach to updating Australia’s Database of Adverse Event Notifications (DAEN) after it was revealed the government body had neglected to include a number of deaths attributed to the vaccine, including that of two children aged 7 and 9.
This comes after a Freedom of Information request by an Australian doctor revealed the Australian pharmaceutical and drug administrator, the Therapeutic Goods Administration (TGA), had not updated its DAEN with the deaths.
Australian Liberal Party senator, Gerard Rennick, told The Epoch Times that he was deeply concerned about the TGA’s failure to update DAEN and is calling for there to be some independent oversight on the TGA, given the conflict of interest.
The senator noted that he was highly concerned that the TGA had soft-pedalled the risks involved with the COVID-19 vaccines, especially those 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.
TGA Independent Review Board
The TGA does have a pre-existing independent review (pdf) vehicle for vaccines called the Vaccine Safety Investigation Group (VSIG).
The group is meant to provide independent specialist immunisation (and other relevant) expertise to assist the TGA in investigating and managing Adverse Event Following Immunisation (AEFI) that require the services of national-level experts.
The group is described as a time-limited working group 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 the vaccine or is listed, but causality has not been established.
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 being 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 Agencies Record on COVID-19 Vaccines
“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.
But 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,” Skerrit 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., and four deaths have been recorded.
Doctors Concerned Over Number of People Suffering Adverse Events
Meanwhile, one Australian doctor who has been given anonymity told The Epoch Times that they knew of hundreds of Australians who were suffering from adverse events and that doctors around Australia were struggling to help them.
“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 Australian 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.”