GoBookMe.com.au – TGA grants provisional determination for Pfizer Covid-19 vaccine in children aged 5 to 11

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Australia’s medicines regulator has taken the first big step in allowing the Pfizer vaccine to be used by a new group of people.

Australia’s medicines regulator has invited Pfizer to apply to have its coronavirus vaccine approved for use in five to 11-year-olds.

The Therapeutic Goods Administration had already provisionally approved this vaccine for use in individuals aged 12 and over.

The TGA on Tuesday issued a “provisional determination”, which means Pfizer is now eligible to apply to vary the provisional approval, for the vaccine to include children aged 5 to 11 years.

Federal Health Minister Greg Hunt said on Wednesday he had been speaking with the head of Pfizer Australia about expediting their application.

Mr Hunt said Australia had the capacity to begin rolling out vaccines to under 12s pending approval from the TGA and a recommendation from the national expert immunisation group, ATAGI.

“We’ve got the supply. We’ve got the distribution mechanism. Now, we’re very hopeful …” he told 4BC Drive.

He would not give an exact date of when he expects the rollout to begin.

“Because we’re dealing with safety and effectiveness for children, [we need to] make sure that it’s a thorough assessment,” he said.

“As soon as it’s been through those two stages, both of which are ready to receive and proceed quickly, then, if it’s a double green light, we’ll have it available for children in Australia immediately.”

Mr Hunt expects Pfizer, which supplies one of Australia’s three Covid-19 vaccines, to make its application to the TGA in the “coming weeks”.

Pfizer last week asked the US medicines regulator, the Food and Drug Administration, to authorise its Covid-19 vaccine for children aged 5 to 11 there.

The drug manufacturer recently conducted a trial with 2268 five-to-11-year-old participants which it said found the vaccine was “safe, well tolerated and showed robust neutralising antibody responses”.

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