Australia’s medical regulator has granted provisional approval for a Pfizer COVID-19 booster for children aged between six months and five years.
The Therapeutic Goods Administration says the booster will protect against severe COVID-19 outcomes including hospitalisation and death.
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Pfizer says while children are less likely to develop serious illness from COVID-19, they are still at risk of complications including long COVID-19.
Pfizer’s Australia and New Zealand medical director said children remain at a higher risk of catching a disease that overlaps with COVID-19, including pneumonia and other upper respiratory tract infections.
“Today’s provisional approval is an important reminder for parents to speak to their healthcare professional about COVID-19 vaccination,” Dr Krishan Thiru said.
The TGA approval is based on US data informed by 4500 participants.
The TGA said the data showed a similar immune response in younger children to those aged between 5 and 11 and the vaccine’s safety was similar to that seen in adults with only mild side effects.
It comes a week after the regulator granted provisional approval to Pfizer’s booster for children aged between 5 and 11.
The take-up of the boosters in Australia will be informed by advice from the Australian Technical Advisory Group on Immunisation.
ATAGI provides immunisation advice to national cabinet, which is due to meet on Friday.
But there are concerns about Australia’s vaccine take-up among poorer and less educated households and people from non-English speaking backgrounds, according to a new ANU study.
Professor Nicholas Biddle said the nation’s vaccine program was stalling, with a lack of uptake putting these groups at heightened risk.
“The proportion of Australians with two doses who go on to receive their third or fourth dose is low compared with many other countries,” Biddle said.
Younger people are also less likely to have had a third and fourth shot, as well as Australians who had already caught the virus.
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