TGA approval for Pfizer Covid vaccine booster dose

The Hon Greg Hunt MP

Minister for Health and Aged Care

The Therapeutic Goods Administration (TGA) has approved a booster dose of the Pfizer COVID-19 vaccine for individuals 18 years and older.

The TGA approval means that the Pfizer COVID-19 vaccine has been found safe and effective to boost protection for individuals aged 18 years and older through a third booster dose provided at least six months after the completion of a COVID-19 vaccine primary course of two doses. The primary course can be of any of the COVID-19 vaccine registered for use in Australia.

Importantly the medical advice is that people remain fully vaccinated with two doses of TGA approved COVID-19 vaccines and the commencement of booster doses will provide additional protection and peace of mind for Australians.

As with all COVID-19 vaccines, final advice on the roll out of boosters will be provided to the Government by the Australian Technical Advisory Group on Immunisation (ATAGI).

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.

The Government also expects that Moderna will shortly apply to the TGA for registration of booster doses for their vaccine.

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.

Australia is a vaccination nation with over 34.6 million COVID-19 vaccines having been administered to date, over 87% of eligible Australians aged 16 and older have received a first dose and over 74% have now received a second dose.

Since 11 October, Australians who are severely immunocompromised have been able to receive a third COVID-19 vaccine dose to boost their protection against COVID-19 to the highest level.

The TGA and the expert medical body ATAGI has been closely monitoring local and international data about the frequency and severity of COVID 19 infection in fully vaccinated individuals to inform booster strategies.

The TGA approval follows careful evaluation of the available data supporting safety and efficacy by the TGA.

The TGA’s decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, clinical and consumer representation.

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