Clive Palmer says the Pfizer vaccine has been a departure from ‘normal usage under Australian law’. Is he correct?



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CoronaCheck #55

Misinformation about the COVID-19 vaccine is spreading. This week, we’ve looked at claims made by Queensland businessman and maverick Clive Palmer about the approval process for the vaccine, and check a social media post shared widely which alleges children will be able to decide whether or not to get the jab without their parents’ consent.

We also bring you the latest fact checks emanating from last month’s massive winter storm in Texas, as well as some news about giant rats.

No tick of approval for Clive Palmer’s vaccine claims

When news broke last week that two aged care residents had been given the wrong dose of the COVID-19 vaccine, billionaire businessman and former MP Clive Palmer was quick to suggest that the jab was unsafe.

In a statement posted to Facebook, Mr Palmer said “revelations that two Australians were ill” following the vaccine mix-up were “disturbing”.


“While I support the use of vaccines which have approval for general use such as measles and other diseases, I am very concerned of the emergency use of this vaccine on the general population,” Mr Palmer said.

“My understanding is that emergency use of a medicine is only authorised if the person receiving the treatment is in immediate danger of dying. This is not the case with millions of Australians who are not ill.”

According to Mr Palmer, the vaccine had been rolled out without complying with “normal usage under Australian law”.

So, what has been the approval process for the vaccine, and is it a departure from the norm?

Firstly, Mr Palmer’s assertion that the 88-year-old man and 94-year-old woman given the wrong vaccine dose were “ill” is incorrect. According to the most recent reports, neither of the patients — who were given a dose similar to that of early trial participants — had shown any adverse reaction to the vaccine.

Mr Palmer is also incorrect to claim that the jab had been approved on an “emergency” basis.

Holding it with mask
Pfizer’s COVID-19 vaccine has been given “provisional” approval, which the TGA says is different to an emergency use authorisation.(AAP: Albert Perez)

According to a spokeswoman for the TGA, the administration “does not have an ‘Emergency Use Authorisation’ pathway for COVID-19 vaccines” and approval for the jabs had been granted through a formal regulatory process.

As detailed on the TGA’s website, this process has seen a number of COVID-19 vaccines granted “provisional” approval, effective for six months.

“The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data,” the TGA said in a media release issued in January.

“In making its decision to grant these provisional determinations, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.”

This pathway is not unique to COVID-19 vaccines, as evidenced by a 2018 document from the TGA on the provisional registration process for prescription medicines.

“These medicines are registered on the basis of preliminary clinical data, where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required,” the document says.

Despite Mr Palmer’s claim, neither that document nor a web page outlining the approval process specific to COVID-19 vaccines states that provisionally approved treatments should only be used in cases where a person is in “immediate danger of dying”.

Elsewhere in the world, however, COVID-19 vaccines have been approved under “temporary emergency use authorisations” (or EUAs), according to the TGA spokeswoman.

“EUAs are not the same as regulatory approval, and have been made in response to the very high COVID-19 disease burden and risk in those countries,” she said in an email, listing the US, UK, Canada and Singapore as examples.

“In these cases, the potential benefits of early access are balanced with risks associated with the uncertainties of not having evaluated a full regulatory data set on safety, quality, and effectiveness.”

According to the spokeswoman, Australia was one of the only countries in the world to have issued formal regulatory approval to the Pfizer and AstraZeneca vaccines.

“This approach of formal approval will be followed for other COVID-19 vaccine candidates if they are approved by the TGA,” she added.

A minor debate

With the COVID-19 vaccine rollout now under way, parents will soon have to decide whether their children get the jab. Or will they?

According to an image shared widely on Facebook, the Victorian Government will be letting kids decide for themselves, provided their school principal allows it.

“SO [the] VICTORIAN GOVERNMENT HAS DECIDED The School Principle [sic] can DECIDE if your child can make THE VERY BIG decision to have the Covid VACCINE,” the posting says. “You can imagine how I feel about this but HOW do YOU feel about this?”

The image included a screenshot of text taken from a Victorian Department of Health and Human Services web page, which discusses the concept of “mature minors” in relation to the Government’s secondary school immunisation program.

Mature minors are children deemed capable of making decisions on particular matters such as healthcare before they reach 18 years of age.

“Determining whether a young person is a mature minor requires consideration of whether they have sufficient maturity to understand the nature and effect of a decision to be vaccinated,” the DHHS website noted, explaining that such an assessment could be made by the school principal (in accordance with education department guidelines).

However, COVID-19 vaccines are not part of Victoria’s school immunisation program, which at the start of 2021 covered just three shots: a combined vaccine for diphtheria, tetanus and whooping cough, and one each for human papillomavirus and meningococcal.

A boy receives a flu shot in a doctor's treatment room.
Doctors assess minors for competency “all the time” according to one expert.(ABC News: Freya Michie)

That’s perhaps no surprise, since the federal medicines regulator is yet to approve any COVID-19 vaccine for children under the age of 16.

And while the regulator’s “provisional approval” means students aged over 16 years can legally receive the Pfizer vaccine, they will also be among the last in the country to be offered it, according to the national vaccine rollout schedule.

But is there anything new in children making decisions about their own health?

Lisa Young, a law professor with Murdoch University, told Fact Check that doctors assessed minors for competency “all the time” — for example, when a young woman is prescribed the pill — so, in that sense, there was nothing particularly unusual about the Victorian Government’s approach.

Professor Young explained that parents lose their decision-making authority over certain matters as a child becomes more competent.

“Parental rights of decision making go to [age] 18 in theory, but the law is clear that the matters within parental competency dwindle as the child gets older.”

Moreover, it was not a case of governments “letting” minors make decisions, she said.

“There is no written law that stops them making decisions as such; [however,] there is a law that when they are not competent, parents can take the decision on their behalf.”

From Washington, D.C

In the wake of a winter storm that left millions of Texans without power (and many still directed to boil their drinking water because of health concerns), debate has raged over who was to blame for the crisis, and to what extent renewable energies may have played a role.

According to the Republican Governor of Texas, Greg Abbott, the state’s lack of power came as a result of wind and solar being “shut down”.

“As a result, it just shows that fossil fuels are necessary for the state of Texas as well as other states to make sure that we’re able to heat our homes in the wintertime and cool our homes in the summertime,” Mr Abbott insisted during an interview with Fox News.

But fact checkers at PolitiFact found that Texas was a state with “diverse energy sources” and that grid officials had repeatedly said that a drop in power supply was attributable to all energy sources, as well as the grid’s inability to handle freezing conditions.


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