TGA provisionally approves Pfizer vaccine for children

The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer Australia COVID-19 vaccine, COMIRNATY, for use in individuals aged 5–11 years old, indicating the vaccine is safe and effective for use among this age group. Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia.

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 five to 11 years of age. 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. 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.

As with other age groups, the TGA recommended that the use of the vaccine in children aged 5–11 years should be given in two doses at least three weeks apart. However, a lower dose (10 µg) will be given to individuals aged 5–11 years, compared to that used for individuals 12 years of age and older (30 µg). To differentiate the smaller dose, the vaccine will be dispensed from an orange-capped vial instead of the grey- or purple-capped vials currently used to vaccinate those 12 years and older.

The first shipments 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. Subject to final considerations and recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI), which are expected in the coming weeks, the Australian Government will start rolling out the Pfizer vaccine to 5- to 11-year-olds from 10 January 2022.

It is expected the vaccines would initially be made available through general practices, Aboriginal Health Services, community pharmacies, and state and territory clinics. Once the final ATAGI advice is received, further information on how to book a COVID-19 vaccination will be provided.

The TGA is also currently evaluating an application from Moderna for its COVID-19 vaccine to be used in Australia for children aged 6–11; the government already has supply deals in place to make the vaccine available should it be approved by the TGA and recommended by ATAGI.

Image credit: ©stock.adobe.com/au/Jacob Lund

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