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Telethon study recruiting adolescents for 'high risk' Covid vaccine booster trial
Are you comfortable with this?
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.
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 [[email protected]](project number RGS0000005222).
The study is also running in two other Australian states:
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.
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On safety and efficacy of the mRNA boosters: Australian adolescents set to become Pfizer’s lab rats (again)
West Australian 2021 Covid vaccine safety data, showing rates of 9.2 cases of myocarditis per 100,00 Moderna shots for kids 12-17 years old: West Australian government finally releases 2021 vaccine safety data: vaccines have been pulled from the market for far less than this
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.