Pharmaceutical Regulatory Affairs Expert Calls on Authorities to Suspend ‘Provisional Approval’ Status Granted to COVID-19 Vaccines

Pharmaceutical Regulatory Affairs Expert Calls on Authorities to Suspend ‘Provisional Approval’ Status Granted to COVID-19 Vaccines
A health worker prepares a syringe with COVID-19 vaccine at a vaccination clinic in Montreal on March 15, 2021. (The Canadian Press/Paul Chiasson)
Henry Jom
Marina Zhang

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.”

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,” he said.

In his report (pdf) titled “The Time of COVID,” Altman argues that the problem with Australia’s Database of Adverse Event Notifications (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, 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.

“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,” he 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.”

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.”

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.”
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

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.”

Zachary Stieber contributed to this report.
Henry Jom is a reporter for The Epoch Times, Australia, covering a range of topics, including medicolegal, health, political, and business-related issues. He has a background in the rehabilitation sciences and is currently completing a postgraduate degree in law. Henry can be contacted at [email protected]
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