Australia’s medicines regulator, the Therapeutic Goods Administration, has granted provisional approval for Pfizer’s comirnaty COVID-19 vaccine to be used as a booster shot for teens aged 16 and 17.
The dosage for this age group will be the same as for adults and the booster dose can be administered within three to four months after receiving the primary two doses, regardless of the branding of the first two doses.
This decision follows TGA’s provisional approval to Pfizer for the use of its comirnaty vaccine as a booster in individuals aged 18 and older on Oct. 26, 2021. Booster doses for those aged 16 and older has also been approved for use in the United States, Israel, and the United Kingdom.
“It is the first of the two green lights that are necessary. The Therapeutic Goods Administration, our medical regulator, has said that Pfizer in 16 to 17-year-olds as a booster is safe and effective,” Hunt said.
The Australian Technical Advisory Group on Immunisation (ATAGI) will soon be expected to provide advice and further information on when this age group will become eligible to receive the boosters.
“We’re hopeful to get advice from them within the next week, if not earlier,” Hunt said, promising that once approved by the ATAGI, boosters will be made available immediately.
The minister said that booster take up has been “extraordinary” with 232,000 doses as of Jan. 27.
“Two thirds of the population that are eligible have already taken up the booster so we’re actually seeing a booster take up at a faster rate than the highest daily rate from first or second doses,” he said.
He said that those who have been infected with the Omicron strain of the novel coronavirus should still get the booster shots.
“That is the very clear medical advice from the Chief Medical Officer of Australia,” he said.
The TGA will continue to monitor ongoing trials associated with booster doses for younger children.
According to the TGA, provisional approval for the vaccine is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
