TGA grants provisional determination for two 'Omicron' vaccines

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The TGA has granted two provisional determinations to Pfizer's COVID-19 vaccines that target the Omicron variant on the same day the federal government's advisory committee backed wider access to a fourth dose.

The regulator's determinations apply to the monovalent vaccine COMIRNATY OMICRON and the bivalent COMIRNATY BIVALENT.

The determinations mean that Pfizer can apply for provisional registration of the vaccines within the next six months.

In a recent statement, the company said data from a late-stage trial found that a booster dose of both Omicron-adapted candidates "elicited a substantially higher immune response" against the variant (BA.1) compared to other current COVID-19 vaccines.

The TGA's confirmation of the provisional determinations came on the day the Australian Technical Advisory on Immunisation met and is reported to have backed widening access to a fourth 'Winter' dose of COVID-19 vaccine.

Currently, the fourth dose is only available to people aged over 65, Aboriginal or Torres Strait Islander and aged 50 years and older and people aged 16 to 64 who are severely immunocompromised, are living with complex health needs or a disability.

Reports indicate the committee has recommended the fourth dose for all people aged over 50 but that it should be available to anyone over the age of 30 if they wish to have one.