telethon

Telethon Study Recruiting Adolescents for ‘High Risk’ Covid Vaccine Booster Trial

15 May 2023

3.9 MINS

A Covid vaccine booster trial continues to recruit adolescents despite Australia’s vaccine advisory body, ATAGI, acknowledging the comparatively high risks associated with boosters compared to comparatively low risks associated with Covid infection for healthy young people.

The PICOBOO study was launched at the Telethon Kids Institute last year to, “investigate whether immunity can be maximised by “mixing” vaccine booster types and how long this protection lasts, as well as evaluate how strategies may need to differ depending on age and previously administered Covid-19 vaccines.”

Telethon researchers are measuring neutralising antibodies and cellular immune responses to determine vaccine effectiveness. The study is funded by a $4.1 million grant from the Federal Government. There is no hard time limit on the study – it ends when the funding runs out – but it is nominally projected to run for three years.

PICOBOO study, Telethon Kids Institute

In March this year, a Perth parent received an invitation to enrol her adolescent child into the PICOBOO study from her child’s school. The children are going on an overseas trip and the school suggested that getting the kids boosted in the trial might be a neat workaround to having to do a PCR and risk testing positive and missing the tour.

The parent was shocked, because she was aware that the month prior, ATAGI had recommended against Covid boosters for healthy young people, stating on 08 Feb 2023,

”Adolescents and younger adults have a lower age-related risk of severe COVID-19, and a comparatively higher risk of myocarditis following vaccination.”

The parent wondered if the PICOBOO trial team would still enrol the kids now that ATAGI had acknowledged the asymmetric risk-benefit profile. The email from the school included enrolment forms for the trial (attached at the end of this post), which acknowledged the “rapidly evolving” evidence around Covid vaccines and recommended speaking to a member of the research team if parents had any concerns on this front. So the parent called up and asked some questions.

Following is this parent’s telling of the phone call. It was relayed to me over the phone, so quotes are paraphrased according to the parent’s best recall.


The Research Nurse (RN) who answered the phone was very friendly and informative. I told her about the school trip.

RN: Thanks to the trip, we’re getting more teenagers coming through.

Parent: Which vaccine do the kids get for their booster?

RN: They get either the Pfizer, Moderna or Novavax, but you won’t know which one they got.

Parent: What about side effects?

RN: Risks are quite low. There may be some redness and hardness at the injection site, some tiredness, and feeling unwell that might last for a few days.

Parent: What about myocarditis? I’ve heard people say things about myocarditis risks…

RN: Oh well, yes there have been studies to suggest a very low risk of myocarditis in males under 30.

Parent: What do you mean, low risk?

RN: 2.7 per 100,000 but there are studies to show that the risk with Covid infection is higher, around 11 per 100,000.[1]

Parent: How come you’re still testing this on kids when ATAGI is not recommending it for this age group?

RN: Well they keep changing their mind so you can never keep up! However, because it’s for research purposes, it’s allowed. It’s been through ethics and governance.

Parent: My husband is not supportive. Does my child really need permission from both parents for this?

RN: We only need one parent’s signature…


A spokesperson for the PICOBOO study confirms that despite ATAGI recommending against Covid boosters for young people, full ethics approval has been obtained for this study because it is for research purposes. Information gathered in this study will be used to, “provide more information for ATAGI to base their future decisions on.”

The question for parents to consider is,

Are you comfortable with West Australian children being used as lab rats for an under-tested, novel therapeutic with an asymmetric risk-benefit profile?

Maybe you are.

If you are not, the PICOBOO Parent Guide suggests the following course of action:

If you/your child have any concerns or complaints regarding this study, you/your child can contact the Executive Director Medical Services at Perth Children’s Hospital (08 6456 2222). Your/your child’s concerns will be drawn to the attention of the Ethics Committee who is monitoring the study. Alternatively, you/your child can email [cahs.ethics@health.wa.gov.au](project number RGS0000005222).

The study is also running in two other Australian states:

South Australia: VIRTU@adelaide.edu.au
Tasmania: Research@cliffordcraig.org.au

As this is a subject that tends to draw high emotion, please be reminded that all points of contact for the PICABOO study, for both myself and the parent, were very friendly, helpful and seemingly sincere. Please keep communications civil. Let’s not give those concerned about experimental therapeutics a bad name.

If you have information/links to share that may assist parents in getting across the risk-benefit profile of these products, please add them in the comments. I have added a few of my own below under the header, Resources.

UPDATE: My intention in this post is not to suggest that trials are bad. The point is that there is now abundant evidence of the high risks and low benefits of Covid vaccines to adolescents, and that therefore a trial of this nature is risk-heavy. There is also the question of whether parents can reasonably give informed consent when the risks are being downplayed by the accompanying materials and by the staff, even if unwittingly.

 

[1] The TGA’s official numbers on adolescent Covid vaccine myocarditis, which are lowballed due to under-reporting factor, are higher than the RN’s estimate by the order of 2x to 9x. There is no data on the third dose rate currently available, but note that thus far, the risk of myocarditis increases with the additional dose.

___

Originally published by Dystopian Down Under. Photo by cottonbro studio.

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6 Comments

  1. Kim Beazley 15 May 2023 at 6:08 am - Reply

    “The TGA’s official numbers on adolescent Covid vaccine myocarditis, which are lowballed due to under-reporting factor…”

    This is not true, as data from around the world is consistent with the figures provided by the TGA. And why gloss over the 4 times higher risk of Myocarditis from COVID infection cited? And it should also be noted that Myocarditis from the vaccine is normally mild and self correcting, but that as a symptom of the virus it can lead to permanent heart damage and premature death.

    It’s also not true that they “recommend against” the booster for adolescents and young adults. The correct wording is “not recommended”, a subtle but important difference based, not on the risk but on the potential benefit against a disease which is not normally severe for that age group, which is spelled out i the document referred to (so why the distortion?):

    “For children and adolescents aged 5-17 years with risk factors for severe illness, a booster dose may be beneficial; decision-making around booster vaccination should be based on an individual risk-benefit assessment with their immunisation provider. The risk of severe disease with current high population levels of hybrid immunity in children and adolescents aged 5-17 years without risk factors is now considered to be lower than when previous ATAGI booster advice was issued.”

    And when the writer states that “There is no data on the third dose rate currently available, but note that thus far, the risk of myocarditis increases with the additional dose”, this again is contradicted by the same document she cites as evidence for her claims, DIRECTLY FOLLOWING the sentence she quotes:

    “The risk of myocarditis appears to be lower after COVID-19 booster doses in comparison with dose 2 of the primary course and is lower following Pfizer COVID-19 vaccine as compared with Moderna COVID-19 vaccine in some contexts.”

    So either the writer did not read the document properly, or she is knowingly distorting the facts. Either way, it’s a poor example of fear mongering.

  2. Jim Twelves 15 May 2023 at 8:25 am - Reply

    Rebekah, thank you, this is a most important piece. I am so pleased you are shining a bright light on this ‘research activity’. A few things come to mind:
    1. Surely trials should have been done, really good ones, with proper controls, ‘before’ any worldwide mass role out. To be conducting one now seems to be far from ‘the science’.
    2. Who in our community would willingly support a $4.1 million grant from the Federal Government (our money)? Did we vote for this?

    • Kaylene Emery 15 May 2023 at 12:06 pm - Reply

      Thank you for the balance you bring Jim. This is what the Australian Government has come to. They seek to illicit parents to willingly, participate in such an experiment because God constantly tells us in His Word that He will not, remove our free will.
      It is the enemy and it’s minions who seek to impair our ability to recognise Truth by again saying “ what is truth “? “ Did God really say………”
      Yes – God really did say “ do not” !
      Satan is the father of lies and we the church are being crucified . Should we once again be part of a coward obedient crowd ?

  3. Kim Beazley 15 May 2023 at 9:37 am - Reply

    If only this were an “important piece”, Jim. As my own five minutes of research (all that was needed) shows (see my comment above), it presents a biased and skewed picture of the facts.

    “Surely trials should have been done, really good ones, with proper controls, ‘before’ any worldwide mass role out. To be conducting one now seems to be far from ‘the science’.”

    As the virus mutates, so also the vaccines need to be reconfigured to take account of the new strains. So trials will always be on-going to test the alterations. But those trials do not need to go back to “square one”. They only need to test their effectiveness against those newer strains.

    “Who in our community would willingly support a $4.1 million grant from the Federal Government (our money)? Did we vote for this?”

    Yes we did vote for them to act on behalf of the whole country. That’s how representative democracy works. So if you disagree with the trial, that doesn’t give you the right to question whether or not you voted for it. And to ask “Who in our community” falsely suggests that the whole community must surely agree with you, a strange notion at best. As for the money spent, I’ll happily pay your 25 cents for you, Jim.

  4. Kaylene Emery 15 May 2023 at 7:50 pm - Reply

    Dear Rebekah , so often when I am deeply impacted by the message I forget all about the niceties. And , the niceties are very important so thank you for this fabulous article . Thank you for your attention to detail. Thank you for your courage and integrity.
    Love n blessings to you and those you love.

  5. Chris Smith 7 February 2024 at 4:07 pm - Reply

    To Kim Beazley,
    How about you check the excess death rates since vaccine roll out in our own government data, it’s shocking.
    It tells the truth to what’s going on.!!!
    It’s been proven doctors have lied, studies and tests falsified.
    The whole medical profession for over a century is based on lies
    Rockefeller medicine.!!!

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