Pfizer has been provisionally approved by the Therapeutic Goods Administration (TGA) as a booster shot for teenagers aged 16 to 7 years old, as Australian adolescents get ready to return to school nationwide.
In a statement released this morning, the TGA noted it approved Pfizer as a booster shot for adults aged 18 and over in late October, and that the regulating bodies in the UK, USA and Israel had approved the booster mRNA vaccine for ages 16 to 17.
“Dosing in this age group is the same as the adult population – a booster dose of COMIRNATY may be administered intramuscularly after the completion of a COVID-19 vaccine primary series (2 doses). This primary series can be of any of the COVID-19 vaccines approved for use in this age group, although data on the use of COMIRNATY as a booster with other COVID-19 vaccines is more limited,” stated the TGA.
Provisional approvals permit the Pfizer vaccine to be used for two years and legally supplied in Australia.
While the TGA has approved 16 to 17-year-olds to receive a Pfizer booster shot, it does not mean the age group will be able to book appointments straight away. The third dose will further need to see provisional by the Australian Technical Advisory Group on Immunisation (ATAGI), who will provide advice and further information on the age groups eligibility.
The TGA continued to state the regulatory body is monitoring associated trials for booster shots in younger children.
Continuing their statement, the TGA said:
“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 TGA will continue to actively monitor the safety of the vaccine in all age groups both in Australia and overseas and will not hesitate to take action if safety concerns are identified.”
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