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ABC News
Health
national medical reporter Sophie Scott and the Specialist Reporting Team's Evan Young

Pfizer and Moderna COVID-19 vaccines are on the verge of approval for US kids under five. When could it happen in Australia?

Access to COVID-19 vaccines for children under five is one step closer in the US. (Getty Images: Tang Ming Tung)

The final group of people in the United States still ineligible for COVID-19 vaccines could be receiving them within days after a landmark recommendation from medical experts.

Advisors to the US Food and Drug Administration (FDA) — the equivalent of Australia's Therapeutic Goods Administration (TGA) — have found the Pfizer and Moderna shots to be safe and effective for children as young as six months.

The recommendations still need to be signed off by the FDA and the Centers for Disease Control (CDC), but US authorities are hopeful the vaccines could start being administered from next week.

Does that mean a similar approval for Australian kids could be imminent? 

Here's what you need to know.

When could we see an approval in Australia?

The process for approving vaccines in Australia is separate to that in other countries.

And there are still a few important steps to go through before Australian parents might have access to get a COVID-19 vaccine for their young children.

The first is an approval from the TGA.

Once a vaccine has been approved by the TGA, then it goes to the Australian Technical Advisory Group on Immunisation (ATAGI) — the federal government's expert committee on vaccines — to decide whether it should be rolled out in Australia.

ATAGI chair Professor Nigel Crawford said he was aware of the US FDA review.

"But we cannot make any considerations on a vaccine in Australia until it is approved by the TGA for that target age group," he said.

ATAGI meets regularly to discuss vaccine approvals and makes recommendations after looking at  relevant risks, benefits and uncertainties of the evidence, from clinical trials and any real-world of the vaccine in different age groups.

Children under five could start receiving COVID vaccines in the US within days. (Reuters: Dado Ruvic)

So if and when the TGA has given the green light to a vaccine for the under five's, it should only be a short time until ATAGI makes its determination.

It's then up to the federal government to sign off on the roll out of the vaccine.

How have Australia's other approvals compared to the US'?

Australia has historically followed suit in approving vaccines for different cohorts a number of weeks after the US.

For example, following a worldwide Phase 3 trial, the Pfizer vaccine was approved in December 2020 for emergency use for people aged 16 and over in the US.

The same cohort received provisional approval in Australia at the end of January 2021, about six weeks later.

US approval for use in 12- to 15-year-olds came in May 2021, and Australia followed suit about 11 weeks later in July 2021.

Australia green-lit the jab for five- to 11-year-olds in December last year, about six weeks after the US.

What jabs are already available for young kids in Australia?

There are currently no vaccines licensed for children aged four years and under. 

But in May 2022, the TGA began an evaluation of an application from Moderna to extend the use of its COVID-19 vaccine to children aged six months to five years old.

So far, the TGA hasn't received any other applications from other manufacturers to use their vaccines in kids under five.

Last month, Pfizer announced "topline safety, immunogenicity and vaccine efficacy" from a trial of the jab in children under five.

When it comes to kids, the Pfizer COVID-19 vaccine is available and recommended for children aged five to 11.

The Moderna COVID-19 vaccine is an alternative option for children aged six to 11. 

Details of which vaccines are approved for different age groups are listed on the TGA website.

Data from the National Centre for Immunisation Research and Surveillance found children were less likely to report side effects from COVID-19 vaccines.

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