Australia’s medical regulator* has provisionally* approved the use of Moderna’s Covid-19 vaccine for children aged under six.
The Therapeutic Goods Administration (TGA) examined a North American clinical trial* before making its decision on infants and young children.
Its decision is a “first step” towards allowing the jab and “indicates that the vaccine has met high safety, quality and efficacy* standards”, the TGA said.
It will now be up to the Australian Technical Advisory Group on Immunisation (ATAGI) to recommend to the government whether or not to proceed with vaccinating young children.
Health Minister Mark Butler said sourcing enough doses of the vaccine would be another hurdle to overcome.
“As you can imagine, there is fierce competition by countries in North America, Europe and other parts of the world to get their hands on this very limited supply,” Mr Butler said.
“I’ve reported before that my department is in active negotiations right now with Moderna for Australia to secure as many doses as we possibly can from this very limited global supply.”
Moderna’s vaccine, called Spikevax, has until now only been approved for Australians aged over six. This group can get two doses of the vaccine, 28 days apart. People over 18 can also get a booster shot.
After the TGA announcement on July 19, children as young as six months could be able to get the vaccine. Those under six years old will be recommended to have two Moderna doses.
The strength of the vaccine’s active ingredient will be lower in doses given to small children.
The North American trial was conducted across several sites and involved 6000 participants aged between six months and six years old.
“The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults (18 to 25 years) with a favourable safety profile,” the TGA said.
“Clinical trials also showed that the safety profile in children is similar to that seen in adults.”
The TGA said most side effects seen in children vaccinated in the clinical trial were “mild to moderate” and usually only happened after the second dose.
These side effects included irritability or crying, redness or swelling around the area on the body where the injection was given, tiredness, fever, muscle pain and groin swelling or tenderness.
GLOSSARY
- regulator: a group that oversees or supervises something
- provisionally: in a way that is true for the present time but could change
- clinical trial: a trial or study in which people volunteer to test a new medicine or treatment
- efficacy: effectiveness, how well something works to achieve a desired result
- adverse events: bad side effects
EXTRA READING
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Pfizer jab approved for Aussie kids
How does the coronavirus vaccine work?
QUICK QUIZ
- What is the name of Australia’s medical regulator?
- Which group will now decided whether or not to recommend the vaccine for children aged under six?
- Who is Australia’s Health Minister?
- Which company makes this vaccine and what is it called?
- Where was the clinical trial conducted and how many children took part?
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CLASSROOM ACTIVITIES
1. Write a rhyme
Write a nursery rhyme, or children’s story (you can include pictures). Your purpose is to help little children getting ready to have their first dose of the Spikevax vaccine to understand why it is important. You should also try to make it less scary for little kids who don’t like needles!
Time: allow 25 minutes to complete this activity
Curriculum Links: English, Visual Arts, Science
2. Extension
Why do you think it takes so long for vaccines to be approved for use by younger children? Use information in the story and your own ideas to write a list of reasons.
Time: allow 10 minutes to complete this activity
Curriculum Links: English, Science
VCOP ACTIVITY
I spy nouns
Nouns are places, names (of people and objects), and time (months or days of the week).
How many nouns can you find in the article? Can you sort them into places, names and time?
Pick three nouns and add an adjective (describing word) to the nouns.
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2022-07-21 09:02:22Z
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