Pfizer COVID-19 bivalent (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine

On Wednesday 20 December 2023, the Therapeutic Goods Administration (TGA) granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) for use as a booster dose in individuals aged 5 years and older. The new bivalent vaccine comprises 5 micrograms of famtozinameran based on the Omicron variants BA.4 and BA.5, and 5 micrograms of tozinameran based on the original strain of SARS CoV-2.

In making this regulatory decision, the TGA carefully considered data from an ongoing Phase II/III study, which showed that the vaccine elicited a satisfactory neutralising antibody response against the Omicron BA.4/BA.5 strain and against the ancestral strain one month after the booster dose. The vaccine also elicited a good neutralising antibody response against a number of other currently circulating and emerging variants.

Evidence from extensive use in the US and Europe over recent months has also shown that this booster provides clear reductions in hospitalisation and death. This vaccine has a similar safety profile to the original COMIRNATY booster.

The decision to approve COMIRNATY Original/Omicron BA.4-5 COVID-19 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 potential use of this vaccine in the national COVID-19 vaccination program is still to be determined. The Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on these matters in coming weeks.

mRNA vaccines

COMIRNATY Bivalent Omicron BA.4/BA.5 (tozinameran and famtozinameran) is the third bivalent mRNA vaccine to receive provisional approval in Australia. mRNA vaccines use a synthetic genetic code called RNA to give our cells instructions about how to make the coronavirus' unique spike protein. When our body has made the protein encoded by the mRNA vaccine, it then recognises the spike protein as being foreign and launches an immune response against it. The RNA from the vaccine does not change, or interact, with our DNA in any way.

Supporting regulatory documents

The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.

The following regulatory documents are made available as part of this process:

• Product Information (PI)
• Consumer Medicine Information (CMI)
• Comirnaty Original/Omicron BA.4-5 (tozinameran and famtozinameran) Decision Summary
  The decision summary provides a short overview of the TGA’s evaluation process leading to the registration of a new prescription medicine on the ARTG.
• AusPAR: Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine - Booster dose in individuals aged 12 years and older.
  An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
• AusPAR: Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine – Booster dose in individuals aged 5 years and older – AusPAR will be published shortly.
• Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer)(Tozinameran and Famtozinameran) Labelling Exemption 2023