5 Dec 2021

Australian medicine regulator provisionally approves Pfizer vaccine for children aged 5-11

2:38 pm on 5 December 2021

Australia's Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer vaccine for children between five and 11 years of age.

A vial of the new children's dose of the Pfizer-BioNTech Covid-19 vaccine sits in the foreground as children play in a hospital room at Hartford Hospital, Connecticut, US, 2 November 2021.

Photo: AFP

Federal Health Minister Greg Hunt said the government expected to begin the rollout of the vaccine to the age group from 10 January, once it was approved by the Australian Technical Advisory Group on Immunisation (ATAGI).

"The vaccine dose approved by the TGA for children aged 5 to 11 is the same safe and effective vaccine used for other age cohorts, however is one-third the dose approved for those aged 12 and over," he said.

"The Pfizer vaccine for 5 to 11-year-olds will be distributed to vaccine providers in different packaging to the vaccine approved for people 12 and over, and will be clearly differentiated by being dispensed from orange-capped vials instead of grey or purple capped vials.

"This two-step TGA and ATAGI assessment-and-approval process is the same rigorous process followed for all Covid-19 vaccine approvals in Australia."

Once approved, the vaccine will be available to approximately 2.3 million children in the age group.

More than 87 percent of Australians aged 16 and over are fully vaccinated, with several states recording high numbers of those aged between 12 and 15 also getting the jabs.

The Health Minister said 76.6 percent of Australians aged between 12 and 15 years have had their first dose, with 67.5 percent receiving their second.

"The first shipment of children's doses are due to arrive in Australia by early January 2022 and will undergo the same rigorous batch-testing processes in the TGA laboratories as other batches of Covid-19 vaccines," Hunt said.

The TGA's provisional approval is the first of four steps that need to be taken before children can receive the vaccine.

A second step will be the recommendation of vaccine use from ATAGI.

"The third is training, in relation to the use of the Pfizer vaccine in paediatric cases, and then finally it is the batch-testing," Hunt said during a press conference on Sunday.

"Our batch-testing team will be working right through Christmas, right through the new year."

TGA head says vaccinating children is important, despite lower risk

TGA head Professor John Skerritt said the vaccine had been extensively tested in children with no safety concerns arising.

"There were no safety signals, as we call them, no safety problems identified in those trials," he said.

"But children had some of the same things that adults get - tiredness, sore arms, headache and so forth. But these tended to be brief and fairly short-lived. So we have confidence in the safety of this."

The vaccine is already being rolled out to children in the United States, and is also approved for use in Canada.

Professor Skerritt said that while Covid-19 tended to be very mild in children, it was important they were vaccinated for a few reasons.

These included the small risk of serious illness, the possibility children could catch and spread Covid-19 to family members, and providing parents with the confidence to return children to normal activities such as school and play.

"The effects on social, educational, sporting and physical development of these kids has been affected by Covid," he said.

"And the ability to vaccinate those kids, so that they can return to those activities - their parents can be confident they can return to those activities - is a real step ahead."

Earlier on Sunday, Hunt said the government was considering an application from Moderna for a vaccine for those aged between six and 11 years.

"The government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI."


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