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Pfizer Moves A Step Further Towards Providing Under-12 Vaccine in Australia

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has approved a key step towards the Pfizer COVID-19 vaccine being made available for use in children aged five to 11. The TGA said on Wednesday it had granted a provisional determination to Pfizer Australia in relation to the vaccine. It is currently provisionally approved only for use in people 12 years 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 five to 11 years,” the TGA said in a statement. “This provisional determination is the first step in the process and does not mean that an application for variation has been made by the sponsor or that any such variation will be provisionally approved by the TGA.” However, Pfizer will now need to submit comprehensive clinical data on trials done on the age …

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