Pharmaceuticals giant Pfizer has not yet submitted data on the use of its coronavirus vaccine for children to the Australian regulator but says it is preparing the local approval process in the coming days so that kids can get doses.
Overnight the company, which supplies one of Australia’s three coronavirus vaccines, applied to the US Food and Drug Administration requesting it allow the use of its product in children aged between 5 and 11.
A vial of Pfizer COVID-19 vaccine.Credit:AP
Pfizer submitted data to the US regulator from a study of 2268 participants aged between 5 and 11 that showed the vaccine was safe for children and “and elicited robust neutralising antibody responses” in the younger participants.
Pfizer’s results are the first from a clinical trial of a coronavirus vaccine for this young age group. A spokeswoman for the company said the data had been submitted to the US regulator for an initial review and Pfizer had also requested emergency use authorisation to allow the product to be used by kids in the United States during this stage of the pandemic.
On Friday Health Minister Greg Hunt said Pfizer was “already engaging” with Australia’s regulator and said he was urging the company to submit its data as early as possible.
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A spokeswoman for Pfizer Australia told The Age and The Sydney Morning Herald on Friday the company was yet to submit its data on vaccine use in children to the Therapeutic Goods Administration.
“Pfizer has not yet submitted data to TGA. The first step in the process is to apply for a ‘provisional determination’ to allow formal application for inclusion of the 5-11 year old age group,” she said.
“Pfizer will be making the application to the TGA for provisional determination in the coming days.”
