Pfizer has not yet provided TGA data on COVID vaccines to children

Pharmaceutical giant Pfizer has not yet submitted data on the use of its coronavirus vaccine to children to the Australian regulator, but says it is preparing the local approval process in the coming days so that children can receive doses.

During the night, the company, which supplies one of Australia’s three coronavirus vaccines, applied to the US Food and Drug Administration to allow the use of its product in children aged 5 to 11 years.

One vial of Pfizer COVID-19 vaccine.

One vial of Pfizer COVID-19 vaccine.Credit:AP

Pfizer submitted data to the U.S. regulator from a study of 2,268 participants aged between 5 and 11 years, which showed that the vaccine was safe for children and “elicited robust neutralizing 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 company spokeswoman said the data had been submitted to the U.S. regulator for an initial review, and Pfizer had also requested permission to use it in an emergency to allow the product to be used by children in the United States during this phase of the pandemic.

On Friday, Health Minister Greg Hunt said Pfizer “already had contact” with the Australian regulator and said he encouraged the company to submit its data as early as possible.


It told a spokeswoman for Pfizer Australia Aging and Sydney Morning Herald Friday, the company had yet to submit its data on the use of vaccines for 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 provision’ to allow a formal application for the inclusion of the age group 5-11 years, ”she said.

“Pfizer will send the application to the TGA for a preliminary ruling in the coming days.”

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