I have started a project to try and track the supply chain of Australia’s orders of COVID vaccines to allocation by State from publicly-available information. This project is in its initial stages. At present, I am relying primarily on the Weekly Operations Reports from the Australian Government, and the Covid19 vaccine batch release information provided by the Therapeutic Goods Association (TGA) on its website. So far, I have concentrated on the Pfizer supply.

This investigation is in the public interest, and should not be relied upon in preference to direct evidence from official sources. If you have any better information or comments please let me know.

This audit last updated 21 July 2021, 11:55am WST.

Summary of Pfizer-Comirnaty Deliveries

Here is a visual summary of estimated deliveries by week (4,836,780 doses equivalent), the basis for which is explained in the balance of this note. The period from March to 26 April is the most uncertain:

Comirnaty-Pfizer estimates Australian Deliveries 15 February – 18 July 2021

Pfizer Supply Agreements for Australia

The Australian government has not, as at 5 July 2021, released details of the supply contract for the AstraZeneca vaccine. Source: ABC News 5 July 2021

As early as October 2020 there were reports that the Australian government had provided some indemnities to the manufacturers of AstraZeneca and a proposed Australian manufacturer, for ‘rare’ side effects. It appears this is a standard requirement from Pfizer in emergency situations, but no specific details have been announced.

Details of the Pfizer vaccine agreement, limited to 10 million doses, was first announced on 5 November 2020, but the agreement itself was not released at that time. The first choice, 40 million Novavax, did not end up being approved at any time before the first Pfizer and AstraZeneca vaccines were delivered in 2021.

On 20 November 2020 Pfizer announced it had already made a rolling submission for approval of its COVID vaccine to several countries, including Australia.

In March 2021, the ABC in Australia tried to fact check both Australia’s agreements Pfizer and those of other countries around the world, but concluded there was no publically available information to do so.

Summary details of other Pfizer vaccine supply agreements in the world are available at Pfizer’s website, but there was no announcement by Pfizer about the agreement with Australia on or about 5 November 2020. For example, Pfizer’s press release of 11 November for investors contains a summary of its supply agreement with the European Union:

“Agreement provides a supply of 200 million doses and an option to request additional 100 million doses, with deliveries anticipated to start by the end of 2020, subject to regulatory approval
The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021

Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) in October, and will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study”

Pfizer press release on its website, 11 November 2020 (accessed 8 July 2021)

Pfizer Press release 11 November 2020

Pfizer announced another 100 million dose supply agreement for the European Union in December 2020.

Pfizer December 2020

Press reported EU contract with Pfizer, May 2021, for 1.8 billion doses 2021-2023. Some summary details of the contract are available at the EC’s website.

Indemnity Agreements

There are reports that Pfizer regularly requires indemnity agreements from the recipients of its COVID vaccine with respect to side effects evident after it is administered. Some countries, like India, held out after not initially agreeing to indemnity clauses.

UK December 2020

Argentina in talks with Pfizer about indemnity February 2021

Phillipines February 2021 (with COVAX supply)

South Africa April 2021

The above press report contained a statement from Pfizer that all their agreements in emergency situations contained an indemnity provision, but this was resisted by South Africa and Pfizer may have relented:

“Pfizer seeks indemnity and liability protections in all of our agreements consistent with applicable local laws,” the company said, adding that the terms of the agreement are confidential. “Indemnification clauses are often included in contracts with governments for the supply of vaccines during public health emergencies.”

India June 2021 , June 2021

According to this July 2021 media report, India may have sought additional supplies through the COVAX facility to avoid some of the requirements for giving an indemnity to Pfizer directly.

COVAX

There is also some information in the 11 November 2020 Pfizer press release, relating to the COVAX Facility, which is also of interest to Australia:

“In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that, using a range of technology platforms, aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines produced by multiple manufacturers across the world.”

The COVAX Facility was described in more detail in January 2021.

Pfizer’s January 2021 COVAX press release.

UNICEF February 2021 COVAX/Pfizer information

In June 2021, the use of the COVAX facility was linked to the supply of 500,000 doses that were part of an 811, 890 dose release.

At a press conference on 6 June 2021, Health Minister Hunt said:

Then in terms of doses, what we’re expecting, as we’ve said, is that from July, we will move from a 300,000 to approximately 600,000 a week on average over July.

We’ll actually build up during the course of July, start lower and build up higher over the course of July. That will be maintained, and then during October, November, and December, we will have approximately 27 million doses of Pfizer, and so if we can bring some of those forward, we’ll work to it.

But in addition, we will be receiving in the coming week 500,000 doses from the COVAX facility of Pfizer. That’s now been confirmed, and that goes into our ability to do this, and to support states and territories, and general practices going forward.

Health Minister Greg Hunt, 6 June 2021

6 June Press Conference

Commodore Eric Young said at a 10 June 2021 press conference:

“In terms of supply, as I alluded to on Monday, the Therapeutic Goods Administration has now cleared 811,980 doses of Pfizer vaccine….”

10 June 2001 Press CMO Press Conference

In terms of date of manufacture, these COVAX doses seem likely to be included in the same batch with Pfizer reference FC3558, that the TGA approved by mid June 2021.

AUS orders of COVID19 Vaccine (all types)

The official source of information of Australia’s vaccine orders is the government website:

Australian Gov COVID 19 Vaccines and Response

The Australian government was optimistic in the use of the term ‘secured’ to describe its agreements for supply of vaccines. The actual use of the vaccines was conditional on regulatory approvals, which had not been obtained when the agreements were entered into in November 2020. In the case of Pfizer, TGA release approval did not occur until March 2021.

My summary of Australia’s vaccine orders to 1 July 2021, as per its website and related information is as follows:

Pfizer manufacturing and packaging

Pfizer COMIRNARTY is manufactured as a concentrated COVID 19 vaccine, supplied in multi-dose vials of concentrate, that must be diluted with saline solution prior to application. The unit of manufacture by Pfizer is the ‘vial’, not a dose. Trays of 195 multi-dose vials are packaged in trays of 195 vials (this is 13 x 15).

Pfizer vaccine must be kept at very low temperatures for storage. Up to five trays, when ready, may be put into one of Pfizer’s ‘Shipper’ ice boxes for delivery. The manufacturing process can take up to 60 days (approximately).

Pfizer Manufacturing process: Ekathimerini

An extremely detailed blog account of the manufacturing chain by Jonas Neubert.

Shipper Boxes: Pfizer, Wall Street Journal, RACGP, ABC (Nov 2020)

Each vial contains up to 6 doses when diluted. That is equivalent to 1170 doses per tray. If there are insufficient numbers of low air gap syringes available in Australia, then each vial can only be used for 5 effective doses, or 975 doses per tray. This seems to be the working assumption for administering the vaccines in several of the States, including NSW.

Number of practical doses per vial

Each vaccine tray holds 195 vials, which need to be thawed. A a practical matter, a vial will produce approximately 975 doses using standard stock needles and syringes (5 doses per vial), or up to 1,170 doses using low dead space needles and syringes (6 per vial, when available). NSW Health Advice. As early as February 2021, Victorian Government Factsheet advice was that the 6th syringe would be regularly discarded. This also appeared to be the conservative position of the New South Wales government around the same time.

18 February 2021 Health Minister Hunt MP Press Conference:

“JOURNALIST:
New South Wales has confirmed it will only be able to extract five, not the full six doses from each vile of the Pfizer vaccine because of the type of syringe available.
Are you concerned that we’re wasting up to a sixth of each Pfizer shipment, and what attempts are being made to obtain the correct syringe that ensures there’s no wasted shipment?”

“BRENDAN MURPHY:
So, the standard syringes, which are widely used and which we have supplied in great quantity, they can’t guarantee to get six doses.
Some people can get six doses because there is enough in the vial to get six doses there is no wastage but we understand, if you have a low dead space syringe it is much more reliable than you can get six doses.
And we’ve acknowledged with New South Wales Health that we won’t hold them to getting six doses out of each file.
They will try their best, as will all vaccination providers. We have, on order, some low dead space syringes that will come in the future. But these syringes are the standard ones that are used for all vaccines.”

GREG HUNT:
I would just say this, when we ordered, we based that on the foundation of five, and more than that is a bonus, it’s not the other way round.
More than that is a bonus, and New South Wales has been quietly working on getting the maximum, but we’ve been very cautious, they’ve been cautious in their expectations, more than that, would be a bonus.

Excerpt from Media Conference, 18 February 2021, URL: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/doorstop-interview-about-the-covid-19-vaccine-rollout-on-18-february-2021

Contractual doses per vial likely to exceed the practical doses delivered

The Federal Government media conferences from March onwards (see below) refer to doses, not trays or vials. So, for each delivery, they must convert the delivered trays and vials into assumed doses per vial.

The choice of how many doses to quote in official government announcements is not merely a matter of estimation or conservative calculation. It is very likely that the maximum 6 doses (1170 doses per tray) is quoted because that is also the agreed contractual basis on which Pfizer is supplying its contractually agreed doses to all parties. A conclusion to that effect was stated in this linked article from January 2021.

At least in May 2021 (and most likely, ongoing), the assumption for the amount of Pfizer doses in the vaccine delivered/released announcements is that each of the vials would produce the maximum 6 doses (1170 doses per tray). The doses quoted, if they are not rounded to the nearest thousand, are integer multiples of trays with this number of doses.

For example, consider the number of 352,170 doses that were announced as released at the relevant Australian press conferences on 24 May 2021 and 31 May 2021. This is equivalent to 300 trays at 1170 doses per tray. 300 trays also equates to 58,500 vials (195 vials per tray), and then 6 doses per vial gives the 352,170 doses.

Ongoing Senate Enquiry into COVID 19

Information about the status of COVID vaccine supply can also be obtained from evidence given to the Senate Select Committee on COVID19.

Senate Select Committee Web Page

Weekly Supply/Delivery updates

The principal source of information to the public about both the Pfizer COMIRNATY deliveries and the TGA release information are the media conferences held by the Federal Health Minister (the first of these were 15 February and 3 March 2021), and from 26 April 2021, this has been supplemented by the Weekly Operations Reports by Commodore Eric Young of the Royal Australian Navy. The principle unit of vaccine supply as communicated by The Australian government is the number of ‘doses’, rather than batch numbers or the number of physical trays/vials.

  1. 15 February 2021 Doorstop interview
  2. 15 February Announcement of First Vaccines In Australia (at Sydney Airport)
  3. 2 March 2021 Doorstop interview

At the 2 March press conference, Minister Hunt said:

“Good afternoon everyone. I’m pleased to be able to give you an update on progress in relation to COVID-19 in Australia.
In particular, I’m very pleased to be able to announce another 135,000 Pfizer vaccines have arrived in Australia and are being made available to the Commonwealth. We thank the company for their work and for the consistency of their arrivals.
For the record, that makes 142,000 in the first group, 166,000 in the second group of arrivals and 135,000 in the third group. So we now have 443,000 Pfizer doses that have arrived in Australia. They will be cleared by the TGA, assessed for temperature, although the early signs are positive. And that’s in addition to the AstraZeneca 300,000 which arrived only two days ago, for a total dosage arrival in Australia of 733,000.”

Minister Hunt, Doorstop Press Interviews, 2 March 2021. Source: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/doorstop-interview-about-the-arrival-of-additional-pfizer-vaccines-covid-19-vaccine-rollout-and-aged-care-royal-commission

General information sources:

  1. COVID19 Weekly Operations Reports (from 26 April 2021)

Weekly Operations Reports with details of deliveries seemed to have been delayed, temporarily, as the 5 July 2021 operations report was not available on 6 July (however, it is now there, on the website, as at 15 July 2021).

2. Minister Hunt’s Media Release Page

3. Daily and Weekly Rollout Updates

These rollout updates relate to daily and/or weekly allocations and distribution of quoted doses, rather than to supply and deliveries.

TGA Regulatory Approval

On 7 January 2021, the Prime Minister said in a press statement, apparently in advance of any Pfizer being available for shipment to Australia:

“Pfizer’s global protocols require approximately two weeks for delivery post approval of the vaccine. So the vaccine does not arrive pre approval. The vaccine is only released and distributed to countries once the approval is provided.”

Pfizer was approved by the TGA in late January 2021.

25 January 2021 TGA Approval Report

Prime Minister’s Press Release 25 January 2021

TGA batch release information

TGA Batch Release Information

The Therapeutic Goods Administration in Australia will test each batch of Pfizer COMIRNATY, and if it passes the relevant tests, release it for use. The information about COVID19 batches and releases is available publically, but the TGA only records the manufacture date of the batch, and the release status (e.g. passed, in progress). The quantities in each batch are not reported at the TGA Batch Release website. As stated on that website:

“TGA Laboratories have been performing batch release and testing on all batches of COVID-19 vaccines that have been supplied in Australia. Batch release assessment is a critical part of the regulatory oversight of vaccine quality. It is especially important for vaccines that are provisionally approved, such as COVID-19 vaccines.”

From TGA Batch release page, accessed 21 July 2021. URL: https://www.tga.gov.au/batch-release-assessment-covid-19-vaccines

The above web page detailing releases was created in January 2021 but batch-specific information did not appear there until on or about 19 April 2021, and has subsequently been updated only a few times, including on 29 April 2021, 5 May 2021 and 5 July 2021.

US Diplomats arranged delivery of Pfizer vaccines

A separate delivery of Pfizer, through US diplomatic channels and not TGA, occurred prior to 4 June 2021.

ABC News 4 June 2021

Audit of Pfizer COMIRNATY supply to Australia

The lack of detailed information about the contractual supply, the precise number of trays and vials of Pfizer being delivered in each shipment, and the basis on which doses are being quoted means it is necessary to make some reasonable assumptions about the relationship between delivered doses and the specific batches of Pfizer vaccine approved for release.

If we assume that Pfizer COMIRNATY is delivered uniformally in trays of 195 vials, with a maximum 1170 doses per tray (6 per vial), then reasonable inferences can be drawn as to the number of trays delivered, and the approximate number of boxes they were in. It is reasonable to assume that these numbers are based on an integer number of trays, with 1170 doses per tray, as that consistently reconciles with the quoted number of trays (whereas the 5 doses per vial, 975 doses per tray, does not).

The sequence and timing of deliveries is one way of attempting to reconcile the delivered doses with the relevant TGA batch releases. Here is one possible breakdown of how we could reconcile the amount announced as delivered to 27 June 2021 to an integer number of trays.

The above table illustrates how information has to be pieced together from scarce details, incrementally. When this was prepared, on or about 27 June 2021, it was anticipated that the latest delivery aligned to batch FA5833 because that was the first of the latest of the ‘in progress’ TGA batches on its website. Subsequent TGA website information gives reason to think that these three batches remained ‘in progress’ and another batch, FE3064, had been approved and released at the relevant time.

Pfizer COMIRNATY TGA Batch Releases

This section of the audit takes the details of batches released as per the TGA information, and attempts to estimate the timing of delivery, as a first step in reconciling them to the quantity of doses in the release announcements (including in the Australian Government’s Weekly Operations Reports). It is reasonable to assume that the dose quantities in the announcements are based on an integer number of trays, with 1170 doses per tray, as that consistently reconciles with a whole number of trays (whereas the 5 doses per vial, 975 doses per tray, does not).

The following table illustrates the Pfizer batches that have been recorded on the TGA web page since 20 April 2021 (no details were available there from January to March 2021, and it has been updated a few times since 20 April 2021). The estimated delivery date in Australia is not on the TGA site, but an estimate has been included to indicate likely arrival dates. For this, I have chosen a data at least 3 or 4 days after the Pfizer batch manufacturing date, but it may be slightly longer in some cases. The 5 batches dated 21 and 22 June 2021 are noted on the TGA web page to be for a Pfizer employee vaccination program.

Summary of TGA batch information, with estimated delivery dates

The last 3 batches likely arrived in Australia prior to the previous update of the TGA website on 5 July 2021.

The 29 June 2021 batch FC5029 still appears to be the last shipment received, as at 20 July 2021, but the web page has not been updated since 5 July 2021. The 12 July 2021 operations report described the upcoming release of the 500,760 doses (this is equivalent to 428 trays and 6 doses per vial). This is likely to be the last known delivery, for batch FC5029.

Pfizer COMIRNATY Inventory assessment

Near end of June 2021, there was some public discussion about the amount of COVID19 Pfizer CORMINATY vaccine on hand. on hand in Australia. It was publically stated that there were about 2.3 million ‘doses’ on hand.

The significance of whether the amount on hand is a physical, practical quantity, or an estimate based on the number of trays delivered, is apparent when we try to audit these statements. If there are in fact 2.3 million ‘doses’ on hand, as stated on 21 June 2021, this might refer to 1968 physical trays on hand (at 1170 doses per tray). However, the practical number of doses may be less if only 975 doses per tray (5 doses per vial) is assumed.

Pfizer Australia employees receive special July release

Several batches of Pfizer vaccine, manufactured in June 2021, was delivered to Australia no later than 6 July and passed by the TGA without testing. The TGA web site noted these as batches for “Pfizer Australia employee vaccination program”. If these were released at that time, then it was ahead of some other in-progress batches that had been disclosed by the TGA as at end June 2021.

Ref: TGA Batch Releases (Accessed 6 July 2021)

The updated deliveries (date currently unknown) and releases, as at 6 July 2021, is as shown below (on basis that deliveries must have occurred in last week prior to 5 July 2021, when FE3064 batches were passed).

Updated Weekly Vaccine Operations Reports (5 and 12 July 2021)

This section created 15 July 2021.

Sometime after 6 July 2021, but on or before 15 July, the Vaccine Operations Report dated 5 July was published. It definitely wasn’t on the website on 6 July, but seems to have been given a retrospective publication date of 5 July 2021 anyway. Minister Hunt’s media release page for the 5 July 2021 update contains transcript that was said to be published on 6 July 2021.

No new deliveries were announced on 5 July 2021; only the release of 300,000 doses in the coming week (which would seem to correspond to the 257-tray equivalent in the 12 July 2021 information).

No new deliveries were announced on 12 July 2021; only the release of 500,760 doses in the coming week.

The 12 July 2021 Vaccine Operations Report was published on 15 July 2021. The 300,690 doses (equivalent to 257 trays) that were announced as released have been aligned to the second delivery of batch FE3064 (since FC5029 is still ‘in progress’).

The updated schedules to try and align known batches/deliveries with the Operations Report information are set out below. It is likely some of the details for the March to June will need further analysis and updates.

Known Pfizer batches reconciled to deliveries, as at 20 July 2021

The TGA batch release web page as at 18 July 2021 is still dated 5 July 2021. Deliveries 13, 14, 15 in the audit (batches FA5833,FC2336 and FD9234) are still ‘in progress’. The Pfizer employee batches (FC3558,FC8736,FA7812, FA7338 and FA4598) have been listed as ‘not tested’ since 6 July 2021 at the latest, which would suggest that they have already been approved for release at that time.

July information about bringing forward Pfizer contractual deliveries

On 9 July 2021, the government announced it had been able to bring forward some of the contractual arrangements for Pfizer: ABC News 9 July 2021

On 18 July 2021, there was a confirmation that 3 million dose deliveries are being brought forward (or have been brought forward) from the fourth quarter of this year. See Minister Hunt Press Conference 18 July 2021.

GREG HUNT:

“But on top of that, the significant growth in Pfizer, which Australia has secured, will also become available. In terms of the earlier arrivals from within our 40 million doses, critical step forward, those three million doses that we were able to bring forward from the fourth quarter to the current quarter, that will see Pfizer doses to GPs more than double this week, going from just over 100,000 to approximately 250,000.”

Health Minister Hunt, 18 July 2021

In an ABC interview with Sabra Lane on 9 July 2021, the Prime Minister said:

LANE: The boost in Pfizer supplies that the Government’s negotiated, is that a tripling of initial supplies or the overall order? What will that mean from Monday week?

PRIME MINISTER: What it means on the 19th of July is that we’ll have a million doses coming in every week from Pfizer. And that means, to put it in perspective, we had in the month of June, we had 1.7 million Pfizer doses. This month we’ll have 2.8 million. And in August, we’ll have 4.5 million. That’s what’s been outlined to us by Pfizer and Pfizer have been hitting all their marks for us. When they said they’re going to send something, they send something. And to be able to confirm this publicly also is important. And so those additional doses, the bring forward of those doses, which I commend Minister Hunt for and Professor Murphy and General Frewen, we’ve been working on this for some time to get that bring forward. We’ve also got 1,300 additional GPs coming on stream this week, sorry this month, to deliver those Pfizer doses that are coming through. And so we really are hitting the marks we now need to hit. We’ve done a lot of catch up in particularly over the month of June, and that’s seen us now hitting the levels we need to get this job done and have everyone offered a dose by the end of the year.

LANE: Okay, so that means everyone will be offered a vaccine by Christmas?

PRIME MINISTER: This is our, this is our plan. And if we keep these rates up, Sabra, we’ll hit that.

Excerpt from 9 July 2021 interview exchange between Scott Morrison (PM), and Sabra Lane, ABC journalist.

To explain and put the 1.7M into perspective, this appears to reflect four announced releases of vaccine during June 2021, as follows:

Announcement dateAnnounced doses
07-Jun-21298,350
10-Jun-21811,980
21-Jun-21298,350
28-Jun-21298,350
TOTAL1,707,030
Summary of June 2021 announced Pfizer releases

The 811,980 is not all part of the regular Pfizer supply, but includes approximately 500,000 doses obtained via the COVAX facility, which leaves 1.2 million doses from regular Pfizer supply. Those doses are based on 6 doses per vial. If we assume just 5 doses per vial, then the 1.2 million is closer to 1 million able to be practically delivered.

In an interview on commercial radio on 20 July 2021, Health Minister Hunt said:

What we’ve been able to do by working with the company is bring forward three million doses from Q4 to Q3 and we’re always working to expand on that. But the Prime Minister and myself wrote to the head of Pfizer in May when we believed we had the best possible chance of that outcome, but we’d been working behind the scenes throughout.

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