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Confusion as Government walks back bivalent dose commitment

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Moderna will not supply Australia with 15 million doses of variant-specific vaccines by the end of the year, despite having a supply agreement in place to do so.
 
The revelation represents a major break from previous characterisations of the agreement – by both Moderna and the Federal Department of Health and Aged Care (DoH) – from as far back as May 2021, when the deal was first announced.
 
As recently as last week, the DoH also seemingly confirmed the doses would arrive on schedule, stating that Moderna would fulfil its ‘full order’ of 15 million doses in 2022.
 
However, a correction request sent to newsGP the day after that article was published clarified that the 15 million doses referred to by the spokesperson applied to the ‘total’ Moderna doses to be delivered this year, not just bivalent vaccine.
 
The spokesperson also stated that this did not represent a change to the agreement, even though the department’s own website at the time explicitly stated that the Australian Government had an agreement in place for ‘15 million doses of variant-specific versions … available in 2022’.
 
‘Moderna has fulfilled its contractual obligations with the department to date and is expected to meet remaining requirements by the end of the contract term,’ the spokesperson said.

‘The 15 million Moderna doses to be delivered in 2022 include all currently available formulations of the Moderna COVID-19 vaccine that have been provisionally approved by the Therapeutic Goods Administration [TGA] for use in Australia.’
 
They listed ‘variant-specific versions’ as:

• Moderna Spikevax (elasomeran)
  • Six months to less than six years (six months to five years) – 25 micrograms of elasomeran in 0.25 ml vial
• 12 years and older – 100 micrograms of elasomeran in 0.5 ml vial 
• Moderna Spikevax Bivalent Original/Omicron BA.1 vaccine (elasomeran/imelasomeran) – 25 micrograms of elasomeran and 25 micrograms of imelasomeran in 0.5 ml vial

It is not clear how cohort-specific doses that contain the same vaccine – elasomeran – and target the original SARS-CoV-2 strain represent ‘variant-specific’ doses.
 
Nor is it clear how Moderna will meet the remaining requirements of its agreement, if it indeed has not changed since first being revealed.
 
On 12 May 2021, the company issued a press release hailing a new supply agreement with the Australian Government that would see it deliver 25 million vaccine doses by the end of 2022.
 
‘This includes 10 million doses of Moderna’s COVID-19 vaccine against the ancestral strain [mRNA-1273] to be delivered in 2021 and 15 million doses of Moderna’s updated variant booster vaccine candidate,’ the release stated.
 
Former Federal Health Minister Greg Hunt also published a similar release, stating that the agreement included ‘15 million doses of Moderna’s updated variant booster vaccine in 2022’.
 
When questioned about this apparent discrepancy, the DoH said the information provided ‘was correct at the time of release’. 
 
‘As Australia’s response to the pandemic has evolved and new variants have emerged, the 15 million doses have included variant-specific versions which following TGA approval were available in 2022,’ a spokesperson said.
 
The 15 million dose claim also appeared in other DoH-issued media releases, including August and September 2021, while at a 12 July 2021 press conference then-Minister Hunt said the doses are ‘specifically contracted to allow for variation as a very nimble platform to adapt to any variants’.
 
The claim was also on the DoH’s vaccine agreements webpage until 27 September 2022, after which it was updated following enquiries by newsGP.
 
Ongoing mystery
The bivalent vaccine is expected to become available from 10 October, but it is not known how many doses are currently in Australia, nor the number that are expected to arrive by the end of the year.
 
Moderna directed all enquiries related to vaccine supply to the DoH but the department spokesperson declined to comment, citing ‘contractual agreements’.
 
The contractual agreement – which according to the DoH has not changed – did not prevent then-Minister Hunt from revealing how many Moderna doses were in Australia following the first shipment in 2021.
 
It also places more pressure on the Government to secure mRNA doses for 2023 and into the future, as it is yet to secure a supply agreement with Moderna beyond the end of the year, with the recently published Halton review warning of an ‘anticipated shortfall’.
 
‘It’s obviously something we now need to bear in mind,’ Federal Health and Aged Care Minister Mark Butler told reporters earlier in the week.
 
Accessing bivalent doses may prove challenging, with Moderna already due to supply hundreds of millions of doses to various larger markets in the coming months.
 
The US, UK, Canada and Europe all have existing agreements in place, including an August deal with the latter that will see an additional 15 million bivalent doses arrive prior to the end of 2022.
 
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bivalent COVID-19 Moderna variant specific

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