Healthy infants, children and adolescents aged <18 years are not recommended to receive COVID-19 vaccine

COVID-19 vaccine is not recommended for healthy infants, children or adolescents who do not have medical conditions that increase their risk of severe illness. This is because the risk of severe illness was is extremely low in this cohort over the course of the pandemic, and benefits of vaccination are not considered to outweigh the potential harms.1,2

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COVID-19

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Last updated

2 May 2025

Last reviewed

2 May 2025

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By Maryanne Demasi PhD

It didn’t come with a press conference or a media blitz. In fact, there was no announcement at all.

But sometime around 2 May 2025, the Australian Department of Health quietly removed its recommendation for Covid-19 vaccination in healthy children and adolescents under 18.

The change was tucked into an online update to the Australian Immunisation Handbook—no headline, no ministerial statement, no media campaign to inform the public.

For the first time since the rollout began, Australian health authorities now say that unless a child has underlying medical conditions, they do not need the vaccine.

Australia now joins a growing list of countries backing away from the blanket approach to vaccinating low-risk populations.

In the US, health officials under HHS Secretary Robert F. Kennedy Jr. recently removed routine recommendations for Covid-19 vaccination in healthy children and pregnant women.

The CDC now leaves it up to “shared decision-making”—a tacit acknowledgment that the previous universal approach may have overreached.

Denmark, meanwhile, was ahead of the curve.

It stopped recommending the vaccine for healthy children back in 2022, citing data showing that severe Covid in children was exceedingly rare and that the benefits of mass vaccination did not outweigh the harms.

Australia’s policy reversal might be late, but what makes it striking is how quietly it was done—and how much it implicitly concedes.

For years, anyone who questioned the need to vaccinate healthy children was dismissed as anti-science or dangerous. Now, the same authorities who widely promoted the shots are quietly walking it back.

And the adverse events that critics raised early on—myocarditis, pericarditis, and other post-vaccine complications—are no longer fringe concerns. They’re acknowledged in official risk assessments.

The shift also comes at a time when the legal and regulatory framework that enabled the rapid approval of mRNA vaccines is under growing scrutiny.

In Australia, a case brought by Dr Julian Fidge, a general practitioner and former pharmacist, challenged the legality of the vaccine approvals.

He argued that Pfizer and Moderna’s mRNA vaccines should have been classified as “gene therapies” under the Gene Technology Act, and therefore required a licence from the Office of the Gene Technology Regulator (OGTR) before being rolled out.

But the court dismissed the case on procedural grounds, ruling that Dr Fidge lacked standing to pursue it.

https://cairnsnews.org/2024/03/01/vaccine-maker-pfizers-iniquitous-tentacles-have-reached-into-every-corner-of-the-australian-legal-system-while-federal-court-refuses-vaccine-cases/

Still, the case drew attention to whether these products were channelled through the wrong regulatory pathway.

That question is now at the centre of a citizen petition in the US, filed with the FDA in January 2025, claiming the agency “wrongfully and illegally” approved the mRNA Covid-19 vaccines by treating them as conventional biologics, not gene therapies.

According to the FDA’s own definition, gene therapy products are those that use genetic material to alter cellular function for therapeutic use.

By that logic, mRNA vaccines clearly qualify – and should have faced far more rigorous safety testing, including environmental risk assessments and long-term follow-up studies.

As of June, the FDA has not responded to the petition—but the implications are enormous.

If regulators in Australia or the US misclassified these products during the emergency rush, it would expose a systemic failure to apply the appropriate safeguards to an entirely new class of biotechnology.

And it’s not just about legal definitions. The public mood is shifting.

The notion that healthy children and adolescents should have been part of a sweeping global experiment with novel gene-based technologies now looks reckless in hindsight. For the public, trust has been damaged—perhaps irreparably.

That shift in perception has consequences far beyond Covid.

Billions of dollars have been invested in mRNA platforms for other diseases—flu, RSV, and cancer. So what happens if confidence in the technology craters?

Already, the US FDA has announced it will require new randomised clinical trials for annual Covid-19 boosters in “healthy” people under 65—setting a higher threshold for evidence (than immunobridging data) that may make future approvals more challenging.

The industry might dismiss this as just a hiccup—but the truth is, mRNA vaccines were never subjected to the kind of long-term scrutiny typically required of products given to healthy people, especially children.

The argument that urgency justified shortcuts has worn thin.

The real emergency now is institutional—one of captured regulators, collapsing public trust, and a health system so entangled with the pharmaceutical industry it can no longer tell the difference between evidence and marketing.

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