Pharmacy Daily | Provisional approval for bivalent shot

MODERNA'S bivalent COVID-19 vaccine (Spikevax Bivalent Original/Omicron) has been granted provisional approval by the Therapeutic Goods Administration (TGA) to be administered as a booster for adults.

The shot has become the first bivalent COVID-19 vaccine to be approved for use in Australia.

"The adapted vaccine triggers an immune response against two different COVID-19 variants: the original virus and the BA.1 Omicron variant," the TGA said.

"The vaccine should be administered at least three months after a primary series and/or previous booster dose with Spikevax or other authorised COVID19 vaccine, in accordance with official recommendations.

"The Spikevax Bivalent Original/Omicron vaccine contains 25 micrograms of imelasomeran that targets the Omicron variant BA.1, and 25 micrograms of elasomeran that targets the original strain of SARSCoV-2.

"All other ingredients are the same as those used in Moderna's original COVID-19 vaccine.

"The Spikevax Bivalent Original/Omicron vaccine elicited a superior neutralising antibody response against Omicron BA.1 strain and a similar response against the ancestral strain, 28 days after use as a booster dose compared with the original Spikevax vaccine.

"Initial analysis shows that the bivalent vaccine also generates a higher immune response against the sub-variants BA.4 and BA.5 than the original Spikevax vaccine.

"In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study, which showed that the Spikevax Bivalent Original/Omicron booster has a similar safety and reactogenicity profile to the original Spikevax booster given as a second booster dose.

"No new safety signals were identified."

The potential use of the bivalent shot as part of the national COVID-19 immunisation program, has yet to be confirmed, with the Australian Technical Advisory Group on Immunisation (ATAGI) expected to provide advice to the Federal Government in the coming weeks.