Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older.
Australian Government will start rolling out the Pfizer vaccine to 5 to 11-year-olds from 10 January 2022.
The Government expects to receive ATAGI’s recommendations on how to incorporate this safe and effective vaccine into Australia’s COVID-19 vaccination program over the coming weeks.
Subject to advise from ATAGI, vaccinating the approximately 2.3 million children aged 5 to 11 in Australia will build on the rapid uptake of vaccination among children aged 12 to 15. In just eleven weeks, more than 76.6% of this group have had at least one dose of vaccine, with 67.5% having completed their two-dose course of vaccination.
The use of this vaccine in children aged 5-11 years should be given in two doses at least 3 weeks apart.
The study demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older age groups.
“Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild.”
However, a lower dose (10 micrograms) will be given to children aged 5-11 years, compared to that used for individuals 12 years of age and older (30 micrograms).
To deliver the smaller dose, a different orange-capped vial will be used to vaccinate children. It will be clearly differentiated from the product currently used to vaccinate those 12 years and older.
It is expected the vaccines would initially be made available through General Practices Aboriginal Health Services, community pharmacies, and state and territory clinics.
In making this regulatory decision, the TGA carefully considered data from clinical trials conducted in the United States, Finland, Poland, and Spain which included participants 5 to 11 years of age.
“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.”
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia.
The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical, and clinical fields including consumer representation.
The Government has an agreement in place with Pfizer to receive a sufficient supply of the pediatric vaccine for the entire population of children aged 5 to 11 in Australia.
The first shipment of children’s doses is 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.
The TGA is also currently evaluating an application from Moderna for its COVID-19 vaccine to be used in Australia for children aged 6 to 11 and the Government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI.
However, TGA will publish the Australian Public Assessment Report for this decision in the coming days.
