Moderna Inc’s latest COVID vaccine has just been provisionally approved for use in Australia.
The pharmaceutical giant announced that the Therapeutic Goods Administration (TGA) granted provisional approval for its new Omicron‐containing bivalent booster vaccine, mRNA‐1273.214 Spikevax Bivalent Original/Omicron, on August 29, 2022.
The next‐generation vaccine contains 25 μg of mRNA‐1273 elasomeran (Spikevax) and 25 μg of imelasomeran, a vaccine candidate targeting the Omicron variant BA.1, and has already been approved for use in Switzerland and the UK.
The TGA’s decision was based on clinical trial data from an ongoing phase 2/3 trial, in which mRNA‐1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 μg booster dose of Spikevax in previously uninfected participants.
Specifically, the new booster dose increased neutralizing geometric mean titers (GMT) against BA.1 almost 8‐fold above baseline levels and generated a higher immune response against the sub-variants BA.4 and BA.5 than the original Spikevax, regardless of age or prior infection status.
This is the first bivalent COVID vaccine approved for use in Australia and will be rolled out as a booster dose for active immunization in individuals 18 years of age and older.
Mr Arpa Garay, Moderna’s Chief Commercial Officer, said that the company has been working with the Australian government on implementation and aimed to begin supplying the product by September.
“We are delighted to receive provisional approval from the TGA for our next‐generation bivalent vaccine, mRNA‐1273.214. Australia becomes one of the first countries in the world to approve an Omicron‐containing vaccine, highlighting its continued stewardship in the fight against COVID,” Mr Garay said.
“This is a vital step in helping to keep the Australian people safe from the ongoing threat that COVID represents to global public health.”
Even though the TGA has stated that the potential use of this vaccine in the national COVID vaccination program is still to be determined, current advice is that the vaccine should be administered at least 3 months after a primary series and/or previous booster dose with Spikevax or other authorised COVID vaccine, in accordance with official recommendations.
The exact guidelines for administering the vaccine are expected to be confirmed by the Australian Technical Advisory Group on Immunisation (ATAGI) in the coming weeks.
Provisional approval of vaccines in Australia is subject to strict conditions and Moderna will be required to continue providing information to the TGA on longer term benefits from ongoing clinical trials and post-market assessment.
Similarly, the TGA will continue to actively monitor the safety of the vaccine nationally and despite no new safety signals being identified during the clinical trial, the Authority’s laboratories will assess each batch of mRNA‐1273.214 Spikevax Bivalent Original/Omicron before it can be supplied in Australia.