MELBOURNE, Australia—A clinical trials and pharmaceutical regulation affairs expert has urged Australia’s Therapeutic Goods Administration (TGA) to suspend the “provisional approval” status granted to COVID-19 vaccines and declared Australia’s drug adverse event reporting system “broken.”
Speaking at a conference hosted by the Australian Medical Professionals’ Society (AMPS) named “Reclaiming Medicine” in Melbourne on Sept. 10, Dr. Phillip Altman—a veteran and expert in the areas of clinical medical research and pharmaceutical drug regulatory affairs in Australia—said the number of cases could be higher.
“Because we have a broken adverse drug reaction recording system, and because of underreporting—which is admitted by the TGA—we really do not know the real number of deaths caused by these vaccines,” he said.
“Due to health regulators and the pressure to adhere to the ‘safe COVID vaccine only narrative,’ doctors are often reluctant to admit to the possibility that the COVID vaccines are causing serious injury and death,” he said.
Additionally, Altman told The Epoch Times that the reporting process is subjective, and the individuals involved in ascribing causality are generally heavily conflicted insofar as their jobs and careers are linked to the vaccine industry.
In response, a TGA spokesperson told The Epoch Times in an email that inclusion in the DAEN does not mean that the details of the “event” have been confirmed, or that the “event” has been determined to be related to a medicine or a vaccine.
“In most cases the causal relationship is not certain and the adverse event could be related to other factors,” the spokesperson said.
Additionally, the spokesperson said that health professionals in NSW, Western Australia, Queensland, the Northern Territory and the ACT are required under public health legislation to notify adverse events following immunisation to their state or territory health department. Further agreements between the Commonwealth and GPs “required a commitment” from GPs to report all adverse events to the TGA, the spokeperson said.
Meanwhile, though patients can also report their adverse effects to the TGA, there may be a lack of awareness on reporting outlets. Also, the TGA’s website stated that not all reports to the TGA will be made public on the DAEN.
The TGA listed that if “the adverse event is determined to not be related to the medicine/vaccine (for example, the adverse event is explained by other causes),” then the report may not be included.
“There appears to be a heavy bias in underreporting deaths caused by the vaccines,” Altman said.
Since 1974, Dr. Altman has worked primarily within the Australian pharmaceutical industry in relation to clinical trial design, management and reporting with obtaining new drug approvals; he has also worked with the Secretary of the Department of Health and the TGA.
He said countries such as the UK, Sweden, and Denmark have all moved to pull back their vaccine recommendations due to safety concerns, but not Australia.
Neurological Diseases
Many studies have associated neurological diseases with the COVID-19 vaccination.Perez told The Epoch Times that symptoms for these people appeared on average, within 11.38 days after mRNA vaccination, and most passed away within a few months after symptoms started to appear.
In an email dated June 6, 2022, Perez wrote that all of the patients have since died.
One study told of a patient who “developed constant, shooting, 10 out of 10 upper back pain in between her shoulder blades that radiated to her arms and lower chest” two days after her first Moderna shot.
‘Provisional Approval’ Status of COVID-19 Vaccines in Australia
“Provisional Approval” is a relatively new data regulatory pathway introduced into the Therapeutic Goods Act in 2018.This pathway provides access to new medicines, including vaccines, where the TGA determines that early availability of the medicine outweighs the inherent risks despite additional information still being required.
The manufacturer is required by the TGA to submit additional safety and efficacy data over a defined period to answer specific important outstanding safety and efficacy issues not completed or concluded before the product is “Provisionally Approved.”
The current provisionally approved COVID-19 vaccines are Vaxzevria (AstraZeneca), Nuvaxovid (Novavax), Spikevax (Moderna), COVID-19 Vaccine Janssen (J&J), and Comirnaty (Pfizer).
“Products released under Provisional Approval cannot be considered fully evaluated,” the Altman report states.
“Under these circumstances and because there is pending or outstanding safety and efficacy data to be generated and evaluated, it is premature to declare such drugs ‘safe and effective,’ and the use of these agents needs to be constantly under review in light of emerging safety data to reassess the risk versus any perceived benefit.”
However, the TGA spokesperson accused Altman’s report for containing numerous “inaccuracies” and “significant misinterpretations of information” about the safety of the provisionally approved COVID-19 vaccines.
“Even though the decision to provisionally approve these vaccines was made on the basis of short-term efficacy and safety data, the data submitted to support the quality, safety and efficacy of the COVID-19 vaccines showed a positive benefit-risk ratio. Waiting for data to establish the duration of protection would not have allowed these vaccines to have been available.”
Emergency Use Authorization (EUA) in the United States
A recent study re-evaluating Pfizer and Moderna’s clinical data for emergency use authorization (EUA) resulted in findings contradictory to the U.S. Food and Drug Administration (FDA).The authors found that though the number of adverse events between the vaccinated and unvaccinated groups was similar, the vaccinated people had an increased risk of experiencing multiple adverse events, which the authors observed to be significant.
For Moderna, the vaccinated people had a six percent increased risk of serious adverse events.
The authors argued that the differences in results are because the FDA evaluated data differently.
While the authors only examined adverse events in vaccinated individuals who were given two doses with at least two months of the post-vaccine interval before follow-up, the FDA also added people who were only given one dose or had a shorter period of follow-up.
This allowed them to add an extra 5,666 people to the combined (Pfizer and Moderna) group of individuals who were vaccinated without adverse effects. This meant that a shorter follow-up period would be given to many of the people accounted for and will most likely increase the number of people who showed no adverse effects.
“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events,” the authors wrote.
“Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated.”
A spokesperson for the U.S. Food and Drug Administration (FDA) told The Epoch Times via email that the agency disagrees with the paper’s conclusions.
“Based on the agency’s thorough evaluation of the safety and effectiveness data for the mRNA COVID-19 vaccines, as well as the ongoing safety surveillance of the vaccines, we continue to find their benefits far outweigh their risks in preventing COVID-19, including its most serious outcomes of hospitalization and death,” the spokesperson said.
Meanwhile, Australia’s TGA states that deaths caused by COVID-19 vaccines are “extremely rare” and that most deaths are caused by those with underlying diseases.
Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms, the MJA study states.
Australia’s Reporting System
Altman said that if Australia’s adverse drug reaction reporting system is not fixed, then the provisional approval system needs to be removed.“You cannot have a broken adverse drug reporting system at the same time release drugs that have significant safety concerns,” Altman said.
He added that “no Australian is safe without an efficient DAEN system” and that “transparency and independent oversight is needed.”
In response, the TGA said that its adverse reporting system is just one source of information it uses for safety monitoring; it also reviews published medical literature, reports and analyses “submitted by sponsors,” and “works closely with regulators around the world to share information from vaccination programs.”
