The provisional approval allows children aged five to 11 years to receive the vaccine in two doses, at least three weeks apart, similar to other age groups
Australia’s Therapeutic Goods Administration (TGA) has provisionally approved Pfizer Australia Covid-19 vaccine, Comirnaty, for use in children aged five years and above.
TGA’s provisional approval is valid for two years and allows the supply of the Covid-19 vaccine in Australia.
The approval is subject to certain conditions, including the requirement for Pfizer to provide longer-term efficacy and safety data from ongoing clinical trials, to the TGA.
Australia’s technical advisory group (ATAGI) is expected to provide the government with further advice on the rollout of Comirnaty to the age group.
TGA provisional approval was based on data from clinical trials conducted in the US, Finland, Poland and Spain, in participants five to 11 years of age.
The decision on provisional approval was also recommended by the Advisory Committee on Vaccines (ACV), an independent committee with scientific, medical and clinical experts.
In the study, the Covid-19 vaccine showed an effective immune response in five to 11-year-old children, similar to that observed in older age groups.
Also, the Comirnaty showed a consistent safety profile in children, to that seen in adults, with only mild side effects observed.
Injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills, include the most frequent adverse events in the clinical trials.
The vaccine was already approved in the country, for use in adults and children aged 12 years and above, and the booster dose in adults aged 18 years and above.
The approval allows children aged 5-11 years to receive the vaccine in two doses, at least three weeks apart, similar to other age groups.
However, the company has selected a lower dose of 10µg for the five to 11 years age group, compared to 30µg that used for people aged 12 years and above.
The smaller dose vaccine for children will be delivered in distinct orange-capped vials, to make them differentiated from the product used for other age groups.
TGA stated that it will actively monitor the safety of the vaccine in children and adults both in Australia and overseas and will take required action for any safety concerns if identified.
Also, its laboratories will evaluate each batch of the vaccine before it is supplied.