Correct, Biocelect is Sponsor. They may be until at least 2029.π€· Afaik the government renegotiated the contract so 100% credit is applied to future invoices. I cannot see any compulsion to apply for registration in a timely manner with a sense of urgency to address equity.
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This is truly an unfortunate situation. It seems that as of today the public record indicates Biocelect as the Australian sponsor - not Sanofi. So the government must procure doses.
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.@Mark_Butler_MP can you confirm a purchase agreement is still in place please?
What has @Novavax told you about the timing of a new TGA submission via Biocelect, the Sponsor, for updated Nuvaxovid? Do they understand the urgency? Do you?
#auspol
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The management plan is "consider using the Special Access Scheme pathway B."
So I dutifully try.
Biocelect won't participate.
Alfred Health won't participate.
That's the plan.
Give hope, then dash.
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I see Biocelect are still the Sponsor. How f'cking depressing. I don't see a pathway to Nuvaxovid access through them. Do you @Novavax?
Do you @sanofi
Well, of course, you will not say.
But, I am entitled to my opinion.
#LeftBehind
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I have done everything I can.
I have approached Biocelect personally.
My GP has approached Biocelect.
I have written to Novavax & Sanofi.
I've liaised with repeatedly and been seen at a tertiary hospital clinic.
If I die of Covid, NO ONE gets to say to my kids I didn't try.
They hide my tweets, whoever 'they' are.
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...on the ARTG eg Biocelect or a hospital pharmacy willing to import. One major roadblock seems to be not TGA registered. The fact the vaccine is approved by other regulatory agencies and being deployed appears insufficient. So it's a SAS in name only.
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21 Dec 2025
A question for you @Mark_Butler_MP
Why didn't you or the TGA successfully negotiate participation by Biocelect in the Special Access Scheme, given the TGA request that Novavax withdraw their JN1 application?
Where is the *Safety Net* for the Pfizer medically intolerant?
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10 Dec 2025
Hi Clare, no, I do not know. Last I heard was very unlikely for 2025. There's no evidence it's before the TGA. If the purchase agreement expires, Australia will be entitled to refund. Plan for 2026 unclear, don't know if Biocelect or Sanofi would make a TGA submission or not.
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3 Dec 2025
I have written to Mark Butler, Novavax, Biocelect, The Victorian Health Minister, the ACCC, the Prime Minister, Saefvic, and many others. I have been left for dead. If I could take Pfizer I would absolutely take it. The third one affected my health alot #pwME. Novavax didn't.
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2 Dec 2025
.@Mark_Butler_MP pick up the phone and ask Biocelect and @Novavax to participate in the Special Access Scheme.
*It Exists for a Reason.*
This should have been done before the XBB & JN1 application withdrawals. Stop leaving people behind. Work with the states please.
@VicGovDH
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Um @SBSNews I can't access a Covid booster. How many summers or winters will this continue, not offering technology choice? Investigate! Ask TGA if they discussed a Special Access Scheme pathway with Biocelect b4 their request to withdraw JN1 Nuvaxovid TGA application.
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This prompted me to call Biocelect: official response is JN1 is not approved & will not be available to Australians βfor 2025/26 seasonβ π
I asked exactly what that season is & they couldnβt be more specific, also asked if theyβre reworking application & theyβll get back to me
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This β¬οΈ is consistent with my experience (& others) with Biocelect - they will not help individuals or individual medical professionals access Novavax vaccines - I always wondered if they were scared it would impact their own application to help us go around the TGA π€ π€·ββοΈ
28 Oct 2025
My GP advises today the Australian Sponsor of Novavax is not participating in the Special Access Scheme, so there's another door slammed shut @ANAO_Australia
@Mon4Kooyong
@healthgovau
@MaryAnneThomas
@acccgovau
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If you want to understand exactly what has happened with TGA interactions, read the August 6 2025 10Q SEC filing by Novavax for yourself, and then speak directly to senior management at the Sponsor, Biocelect.
Do not rely on AI, which makes stuff up!
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Contact pages:
novavax.com/contact-us
sanofi.com/en/contact
biocelect.com/contact
Phone numbers:
Novavax US: 1-844-NOVAVAX (844-668-2829
Novavax AU (product complains): 61 2 7202 1444
Sanofi AU: 1800 818 806
Sanofi NZ: 0800 283 684
Biocelect (AU/NZ): 61 1300 907 411
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So where does this leave us? Unfortunately not much further along than we began. To review:
Novavax licenses use of its vaccine platform to Sanofi.
Sanofi handles global sales and distribution.
Biocelect is currently the sponsor that advances regulatory proposals in AU/NZ.
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Sanofi is the global commercial lead for Novavax starting in 2025.
This means that they'll work through sales, distribution, and regulatory costs, offloading work from Novavax.
Since Biocelect is the only distributor of Novavax in Australia, this may require new agreements.
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So why did Novavax (via Biocelect) abandon approval of XBB.1.5 and never try to get JN.1 approved after that?
Consider that XBB.1.5 was withdrawn on May 21, 2024 by Novavax through Biocelect.
Just 11 days earlier, they had announced their Sanofi partnership.
ALT Nuvaxovid (Novavax) In January 2021 it was announced that the Government had secured 51 million doses of the Novavax vaccine. The Novavax vaccine is one of 9 supported by the Coalition for Epidemic Preparedness Innovations, a global partnership to accelerate vaccine development. The TGA provisionally approved the Novavax vaccine for use in Australia on 19 January 2022, and granted full registration to the product on 26 October 2023. The Australian Government advises that the Novavax ancestral vaccine is no longer available in Australia. Novavax ceased manufacturing their ancestral vaccine in early 2022. The last batch of ancestral Novavax expired on 31 January 2024. The TGA commenced evaluating the XBB.1.5 COVID-19 vaccine from Biocelect Pty Ltd (on behalf of Novavax Inc.) on 9 November 2023. Following discussions with the TGA, on 21 May 2024, Biocelect Pty Ltd withdrew this application, meaning the TGA is no longer evaluating this vaccine for use or supply in Australia.
ALT Press Release: Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines May 10, 2024
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