TGA approves Pfizer booster shot for Australians

While still pending further approval by ATAGI, the third Covid dose, a booster, will begin to be administered as soon as November 8.

A third-dose Pfizer shot has been provisionally approved for use as a booster, the Therapeutic Goods Administration has announced.

The booster shot is expected to be delivered to Australians aged over 18 at least six months after the “completion of a Covid-19 vaccine primary series”.

Fully vaccinated Australians could receive the Pfizer booster shot as early as November 8. While still pending further approval by ATAGI, if successful the program for the general public would begin one month after boosters were made available for those who are severely immunocompromised on October 11.

Federal Health Minister Greg Hunt’s office confirmed the provisional approval of booster shots. “Subject to final ATAGI advice it is expected that a general population booster program will commence no later than 8 November with original priority groups, including people in aged care and disability care settings, to be offered the option to receive a booster as a priority,” a statement read.

Mr Hunt’s office said it expected other vaccine manufacturers would follow Pfizer’s lead in applying for booster approval. “The Government also expects that Moderna will shortly apply to the TGA for registration of booster doses for their vaccine,” the statement reads.

“With over 151 million Pfizer, Novavax and Moderna vaccines already secured for supply into the future, Australia is well prepared to provide booster doses as approvals are provided by the medical experts.”

Under the provisional approval, residents must wait at least six months after their initial series of vaccinations before receiving their booster vaccination.

While Pfizer is the only vaccine which has been approved for use as a booster shot, it does not require residents to have had the Pfizer vaccine as their initial two doses.

The TGA did however note that there is limited data on the efficacy of a Pfizer booster shot following initially receiving AstraZeneca.

Prime Minister Scott Morrison said National Cabinet would discuss the booster program next week. Picture: NCA NewsWire / Martin Ollman

The approval follows reports in The Australian newspaper on Saturday that the federal government sought to ramp up protection against the virus in aged-care homes and for frontline workers.

Prime Minister Scott Morrison told the Today Show National Cabinet would meet next week to further discuss the booster shot program.

“We have been working steadfastly on this now for some time,” Mr Morrison said. “We will be starting with those in aged care facilities like we did with the vaccine.

“We will be looking at (how) … the states will be keeping a fair bit of their infrastructure in place to deliver that. We will obviously be leaning heavily on the primary health network, on pharmacists and GPs who have done the heavy lifting on getting these vaccination rates which … are higher than the UK.”

Australia placed an order for 60 million Pfizer doses for 2022. Picture: NCA NewsWire / Daniel Pockett

Earlier this year, the government secured 60 million doses of Pfizer for 2022 and 25 million doses for 2023, which would enable booster coverage throughout the year.

In July, Mr Morrison said “every Australian would have access to a booster shot if it is needed”.

Australia’s first dose vaccine rate is now higher than the UK. Picture: NCA NewsWire / James Gourley

In a statement on Wednesday, the TGA said the recommendation of booster shots comes off the back of advice that a third dose should be given to “severely immunocompromised people” aged 12 or older, at least 28 days after their second dose.

“TGA provisionally approved the booster dose following careful evaluation of the available data supporting safety and efficacy,” the TGA said.

“Emergency authorisation or regulatory approval of the booster dose has also been granted in the United States, Europe and United Kingdom.

“The TGA continues to work very closely with international regulators to harmonise regulatory approaches, share information and where it speeds up evaluation, collaboratively review Covid-19 vaccines and treatments.”

The announcement comes as the US Food and Drugs Administration has recommended approval of the Pfizer Covid-19 vaccine for children aged 5-11.

Data from Pfizer-BioNTech indicate the vaccine is 90.7 per cent effective in preventing symptomatic illness among children, and that the benefits of vaccination clearly outweigh any risks.