TGA provisionally approves Pfizer jab for children aged 5-11

Primary school children are expected to have access to at least one COVID-19 vaccine before heading back to the classroom for Term One next year.

It comes after the Therapeutic Goods Administration today provisionally approved the Pfizer jab for use in children aged five years and older.

Federal Health Minister Greg Hunt made the announcement on Sunday.


“Vaccinating five to 11-year-old children in Australia against COVID-19 is a significant step closer, with the Therapeutic Goods Administration provisionally approving the Pfizer vaccine as safe and effective for use among this age group,” Mr Hunt said.

“The TGA’s provisional approval of the Pfizer vaccine for five to 11-year-olds was based on a careful evaluation of available data to support its safety and efficacy among this age group.

“The vaccine dose approved by the TGA for children aged five 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.”

Mr Hunt said the smaller dose vaccines will be distributed to providers in different packaging to the vaccine approved for people 12 and over.

“It will be clearly differentiated by being dispensed from orange-capped vials instead of grey or purple capped vials,” he said.

The vaccines are expected to initially be made available through General Practices Aboriginal Health Services, community pharmacies and state and territory clinics, with further information to be made available over the coming weeks.

In a statement released a short time ago, the TGA said they granted approval for the use of the vaccine in young children after “carefully considering” data from clinical trials conducted in the United States, Finland, Poland and Spain.

“The study demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older age groups,” the TGA said.

“Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild.

“The most frequent adverse events seen in clinical trials in children aged 5-11 years were injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills.”

Subject to final considerations and recommendations from the Australian Technical Advisory Group on Immunisation, the rollout of the Pfizer vaccine for children will begin on 10 January, 2022.