Australia’s Adverse Drug Reporting System is ‘Broken,’ Says Pharmaceutical Regulatory Affairs Expert

MELBOURNE, Australia—A clinical trials and pharmaceutical regulation affairs expert has declared Australia’s drug adverse event reporting system—Database of Adverse Event Notifications (DAEN)—“broken.”

Dr. Phillip Altman has also urged Australia’s Therapeutic Goods Administration (TGA)—the equivalent of the U.S. Food and Drugs Administration (FDA)—to suspend the “provisional approval” status granted to COVID-19 vaccines.

This comes after the TGA reported 135,978 cases of total adverse events following COVID-19 immunisations to Sept. 4. The TGA has also identified 13 reports where the cause of death was “linked” to vaccinations from the 937 reports it received and reviewed.

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,” Dr. Altman said.

In his report (pdf) titled “The Time of COVID,” Dr. Altman states that the problem with DAEN is that its system involves voluntary reporting and that most doctors are reluctant to report adverse drug reactions to vaccines due to fear of being “accused” by health regulators, namely the Australian Health Practitioner Regulatory Agency (AHPRA), of being “anti-vax.”

“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, Dr. 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.

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,” said Dr. Altman.

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.

“After 18 months of use, worldwide use, we are seeing the highest rates of death and serious adverse events ever associated with any drug released in history,” Dr. Altman said, adding that cases of deaths, cancers, heart attacks, stroke, diabetes, and neurological diseases that are associated with the vaccine have “risen significantly” around the world.

Neurological Diseases

Many studies have associated neurological diseases with the COVID-19 vaccination.

A pre-print study co-authored by Dr. Jean-Claude Perez, the late Nobel Laureate Prof. Luc Montagnier, and Dr. Claire Moret-Chalmain documented 26 cases of Creutz-feldt Jakobs Disease (CJD) with mRNA COVID-19 injections.

CJD is a fatal and incurable disease that progressively kills all the brain cells of the person affected. It is very rare and affects about 1 to 2 people out of 1 million every year.

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.

Other studies on rare neurological conditions such as neuromyelitis optica (NMO) have also emerged in individuals vaccinated with mRNA injections. It is a relapsing disease that kills cells in the central nervous system and can be physically debilitating.

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.

Both Pfizer and Moderna did not respond to requests to comment from The Epoch Times.

‘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.”

In a June 2019 statement, the TGA said that it uses the provisional approval pathway when a new medicine is a promising treatment for a “serious or life-threatening condition.”

“However, it is important to be aware that our knowledge of the risks and benefits of these medicines is less certain than other approved prescription medicines,” the TGA said.

“Although evidence is still being collected on the medicine, we have assessed the available data and made a decision based on that.”

To ensure the safety of provisionally approved medicines, the TGA says it guarantees that available evidence shows that the benefits of the medicine outweigh any risks, all applications for approval include a plan on how the drug company will conduct more research on the medicine’s safety and efficacy, monitor the medicine more closely so that any issues are identified, and limit, suspend or cancel the approval if there are major patient safety concerns.

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.

While the FDA found “balanced” and “without meaningful imbalances” in differences between the vaccinated and the unvaccinated people in the Pfizer (pdf) and the Moderna (pdf) studies, the authors found that vaccinated individuals in the Pfizer study had a 36 percent greater risk of serious adverse events.

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.

“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,” the TGA website states.

Further, a study published by the Medical Journal of Australia (MJA) states that of the three million Australians who reported any adverse reactions 0-3 days after vaccination from Feb. 22 to Feb. 30, 35.9 percent reported one or more adverse reactions after the first Pfizer dose, while 54.7 percent reported having one or more adverse reactions after the first AstraZeneca dose.

Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms, the MJA study states.

“In the largest published post‐marketing analysis of the safety of Comirnaty (Pfizer) and Vaxzevria (Astrazeneca), adverse events were more frequently reported by people with underlying medical conditions, including a history of anaphylaxis,” the study states.

Australia’s Reporting System

Dr. 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,” Dr. Altman said.

He added that “no Australian is safe without an efficient DAEN system” and that “transparency and independent oversight is needed.”

Australia’s Therapeutic Goods Administration (TGA) did not respond to The Epoch Times requests for comment.

Zachary Stieber contributed to this report.