TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults

On 27 October 2022, the Therapeutic Goods Administration (TGA) provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over. This is the second bivalent COVID-19 vaccine approved for use in Australia.

In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study, which showed that the COMIRNATY Original/Omicron BA.1 vaccine elicited a superior neutralising antibody response against Omicron BA.1 strain and a similar response against the ancestral strain, after use as a booster dose compared with the original COMIRNATY vaccine.

Clinical studies assessing the activity of this vaccine against the BA.4/5 subvariants are ongoing, however initial results demonstrate that this vaccine produces neutralising antibodies against BA.4/5, though to a lesser extent than BA.1.

The TGA’s decision to provisionally approve the BA.1 bivalent vaccine was informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields and including consumer representation. The Australian Public Assessment Report (AusPAR) for this decision will be published in the coming days.

The Government's decision on the use of this vaccine in the Australian rollout will be informed by advice from the Australian Technical Advisory Group on Immunisation (ATAGI).

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400