TGA grants provisional approval to Moderna bivalent Original/Omicron vaccine

On 29 August, the Therapeutic Goods Administration (TGA) provisionally approved Moderna’s bivalent COVID-19 vaccine, SPIKEVAX Bivalent Original/Omicron, for use as a booster dose in adults 18 years and over. This is the first bivalent COVID-19 vaccine approved for use in Australia.

As stated in the TGA’s media release, the bivalent vaccine triggers an immune response against two different COVID-19 variants: the original virus and the BA.1 Omicron variant. 

The vaccine should be administered at least 3 months after a primary series and/or previous booster dose with SPIKEVAX or other authorised COVID-19 vaccines, in accordance with official recommendations. 

Health Minister Mark Butler’s media release stated that “Compared to the original vaccines, ATAGI found it triggers a modest improvement in the immune response against both strains. However, both the bivalent and original vaccines provide significant protection from severe disease against Omicron subvariant infections.” 

“The first doses of the bivalent vaccine have arrived in the country and will now undergo batch testing by the TGA. They will be introduced into the rollout as existing stocks of the Moderna COVID-19 vaccine are exhausted.” 

“ATAGI has not made any changes to its current third and fourth dose recommendations and is not advising any extra doses at this time.” 

ATAGI’s Recommendations

Following this announcement, ATAGI also issued a statement outlining recommendations for the use of this vaccine. 

They are as follows: 

  • The Moderna bivalent vaccine can be used as an alternative vaccine for any booster dose in people aged 18 years or older, according to the current ATAGI recommendations for booster doses.
  • ATAGI has made no changes to the current booster recommendations and is not advising any extra booster doses beyond the second booster dose (fourth dose) in selected populations.
  • Booster doses of COVID-19 vaccine should be given at least 3 months after the most recent COVID-19 vaccine dose or previous SARS-CoV-2 infection.
  • Eligible individuals can receive Moderna bivalent or the original vaccines (various brands) whichever is available to them. Both bivalent and original vaccines result in an improvement in the immune response against BA.1 and BA.4/BA.5 Omicron subvariants, with the Moderna bivalent vaccine showing a small incremental benefit over the original vaccine for Omicron neutralisation.
  • Coadministration of Moderna bivalent vaccine with other non-COVID vaccines is acceptable, as per current ATAGI clinical guidance.
  • The Moderna bivalent vaccine is not recommended for the primary course of vaccination (first two doses in most people or first three doses in severely immunocompromised people).
  • ATAGI does not currently recommend use of the Moderna bivalent vaccine as a booster in anyone under 18 years as it is not registered for this age group.

ATAGI’s complete statement can be found here.

Stay tuned for updates regarding the availability of Moderna bivalent at Heathershaw’s Compounding Pharmacy. 

Opinions or facts expressed within the content have been sourced from various news sources. While every effort has been taken to source them accurately, the pharmacy, its owners, staff or other affiliates do not take any responsibility for errors in these sources. Patients should not rely on the facts or opinions in the content to manage their own health, and should seek the advice of an appropriate medical professional. Further, the opinions or facts in the content do not reflect the opinions and beliefs of the pharmacy, its owners, staff or other affiliates.

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