ATAGI gives Moderna bivalent vaccine green light

From April, another bivalent COVID-19 vaccine will be available after the Australian Technical Advisory Group on Immunisation (ATAGI) approved Moderna’s second Omicron-specific vaccine.
 
The formulation – officially named Spikevax Bivalent Original/Omicron BA.4-5 (Spikevax Bivalent BA.4/5) – has been given the green light for use in people aged 12 years and over who are recommended a COVID-19 booster dose.
 
It contains 25 mcg of the SARS-CoV-2 BA.4/5 Omicron subvariant spike protein mRNA and 25 mcg of the ancestral strain spike protein mRNA.
 
While all COVID-19 vaccines which are currently available provide protection, ATAGI has said that the bivalent booster vaccines, including both bivalent BA.4/5 vaccines by Moderna and Pfizer, ‘are preferred over other vaccines’.
 
The recommendation is based on clinical trial findings, which show that Moderna’s BA.4/5 vaccine induced 5.1–6.3 times greater neutralising antibody levels against Omicron subvariants, including BQ.1 and XBB, at one month compared to those who had previously received a primary series and booster dose of Moderna’s original vaccine.
 
Further to that, early evidence suggests a booster dose of Moderna’s bivalent BA.4/5 vaccine provides greater protection against hospitalisation and death from severe Omicron disease, at 63.8%, compared to a booster dose of Moderna’s original vaccine at 1–3 months in adults, at 38.6%.

Meanwhile, when it comes to possible side effects such as myocarditis and pericarditis, the risk following Moderna’s bivalent BA.4/5 vaccine ‘does not appear to be greater than the risk after a first booster dose of Moderna original vaccine or a booster dose of Pfizer bivalent BA.4/5 vaccine in adolescents and adults aged 12 years and above at this time,’ according to ATAGI.
 
For children aged under 12, Pfizer’s original COVID-19 vaccine is currently the only formulation recommended for use by ATAGI.
 
Moderna’s latest bivalent vaccine was granted provisional approval by the Therapeutic Goods Administration (TGA) on 17 February and is expected to be available in Australia from April.
 
Federal Health and Aged Care Minister Mark Butler announced on Tuesday that the Government has secured an additional three million doses of the formulation, which is in line with recommendations made by Professor Jane Halton AO in the Halton review of COVID-19 vaccine and treatment purchasing and procurement.
 
‘All adults can now get a booster if it’s been six months or longer since their last COVID-19 booster or confirmed infection, whichever is most recent,’ Minister Butler said.
 
Following careful consideration, the Government has fully accepted seven recommendations from the Halton review, and partially accepted the remaining recommendation relating to the National Medical Stockpile.
 
Minister Butler said work has already commenced on implementing the recommendations, including a release of the COVID-19 Management Plan for 2023 and preparing a new advertising campaign.
 
‘[This is] to ensure everyone in Australia, especially populations in vulnerable situations, continue to have the information and awareness to make decisions that help protect themselves and others from COVID,’ he said.
 
ATAGI has said it will continue to monitor emerging evidence related to bivalent vaccines and the changing COVID-19 epidemiology.
 
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