TGA approves booster doses of the Pfizer COVID-19 vaccine, COMIRNATY

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

The provisional approval means that individuals aged 18 years and older may receive a booster (third dose), at least six months after the completion of a COVID-19 vaccine primary series. This primary series can be of any of the COVID-19 vaccine registered for use in Australia, although data on the use of COMIRNATY as a booster with other COVID-19 vaccines is more limited.

Individuals who have received one dose of COMIRNATY should preferably receive a second dose of COMIRNATY to complete the primary vaccination course and for any additional doses.

Further advice on the use of boosters will be provided to government shortly by the Australian Technical Advisory Group on Immunisation (ATAGI).

In addition, consistent with ATAGI advice, the TGA Product Information also now includes a statement that a third dose may be given to severely immunocompromised people aged 12 years and over at least 28 days after the second dose.

Further details of the data supporting these changes are included in the Product Information (PI). The Australian Public Assessment Report (AusPAR) will be published in the coming days.

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

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 Australian Government's priority continues to be completion of a two-dose vaccination schedule as this enables strong protection against severe illness and hospitalisation. Further information on the vaccine roll out will subsequently be published on the Department of Health's website.