Provisional determination granted to Pfizer's COVID-19 vaccine (Comirnaty) - proposed for use in children 5-11 years of age

TGA

13 October 2021 - On 12 October 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer in relation to its COVID-19 Vaccine, Comirnaty.

Currently, Comirnaty is provisionally approved for use in individuals 12 years of age or older. The granting of this determination means that Pfizer is now eligible to apply to vary the provisional approval for the vaccine to include children aged 5 to 11 years.

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Michael Wonder

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Michael Wonder