COVID supply background notes

This is an aggregate set of notes on announcements and other background information for the audit of Pfizer supply in Australia.

This page last updated 8 September 2021, 1:50pm WST.

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

Australian 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:

In a media statement on 26 July 2021, the Prime Minister stated that Australia had secured another 85 million vaccines from Pfizer.

26 July 2021 Media Release

At a press conference on 26 July 2021, Minister Hunt said this, in relation to the ‘booster’ strategy:

Sure. So with regards to the booster strategy, we have, at this point in time, three vaccines. So we have 85 million vaccines from Pfizer, and that is 60 million in 2022 and 25 million in 2023.

We also have 15 million Moderna, which have been ordered, and we’re very confident with the delivery time frames. So that’s 10 million Moderna for the first round vaccinations this year and another 15 million for the booster strategy next year.

And then we have 51 million Novavax, subject to registration, but we have to say the clinical trial results have been outstanding and very, very heartening. We are, on latest advice, expecting the first of those arrivals in the final quarter of this year.

Per Minister Hunt MP. Extract from 26 July 2021 Transcript URL: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/press-conference-in-melbourne-on-26-july-2021-with-an-update-on-the-covid-19-vaccine-rollout (Accessed 27 July 2021).

26 July 2021 Health Minister Hunt Press Conference Transcript

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.

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.

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. At this time the government claimed it was at the front of the queue.

Information obtained under FOI, as reported on 8 September 2021, revealed that Pfizer initiated first contact with The Australian government on 30 June 2020, but arrangements for the government to obtain a Pfizer supply were not completed for several months, even after Pfizer’s urging. Specifically:

“It wasn’t until August 4, 2020, that anyone from the health minister’s office met with Pfizer.”

Quoted from report by Ellen Ransley (Daily Telegraph)

Pfizer vaccines from Poland

On 15 August 2021, the Prime Minister announced (claimed) that he had obtained another 1 million (approximately) doses from Poland, that had already departed from Warsaw yesterday. PM. ABC News. This was, apparently, because ‘a significant agreement was reached with the Republic of Poland’. The Prime Minister’s office suggested further diplomatic channels were being used to try and obtain vaccine. The implication of such recourse to diplomatic channels with foreign nations is that sourcing more vaccine directly from Pfizer by agreement is not presently an option.

Details of the Polish agreement have not been disclosed. However, the total amount has been divided into two groups, which happen to equal an integer number of trays (at the full 1170 doses per tray, 6 per vial etc):

Claimed dosesTrays equivalent (1170 ‘doses’ per tray)
530,010453
470,340402
Total: 1,000,350855 trays
The ‘Polish’ agreement announced by the Prime Minister on 15 August 2021 (a weekend!)

The TGA issued a statement on their website on 16 August 2021 that they had approved these (within a few hours it seems). The media release stated, in part:

16 August 2021

The Therapeutic Goods Administration (TGA) has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

These doses are all from one batch of the vaccine produced from the same plant in Europe as other doses of this vaccine imported directly by Pfizer Australia.

The TGA has reviewed all batch release and transportation / cold chain documentation as satisfactory for release. These doses were imported directly by the Australian Government after purchase from the Polish Government.

URL: https://www.tga.gov.au/media-release/tga-batch-release-pfizer-vaccine-purchased-government-poland (Accessed 19 August 2021).

The source of the Pfizer vaccines purchase by Australia from Poland was queried by the ABC Fact Check reports, who were told on or about 20 August 2021:

In a statement, a spokesman for the Therapeutic Goods Administration (TGA) told Fact Check the vaccines arriving from Poland had been manufactured in Belgium and had an expiry date of November 30, 2021.

“The TGA has completed the standard batch release process for these doses,” the spokesman said.

“The TGA can confirm the doses are the same in identity, composition, strength and purity as the doses purchased through Pfizer Australia.

Pfizer vaccines sourced from Singapore

On 31 August 2021, the Prime Minister announced Australia would be obtaining another 500,000 Pfizer vaccines from Singapore (in a swap deal), to be delivered this week. ABC

On 6 September it was reported that 500,000 doses from Singapore had arrived in Australia and had been dispatched by TGA.

September 2021 – UK Swap Pfizer Vaccines with Australia

On 3 September it was reported that Australia had arranged for a swap deal with the UK, to supply 4 million vaccines, the first to be departing on 5 September.

“There will be another set of flights in a couple of days, but we’ll pretty much be getting a million of the four million every week over the next four weeks,” Lieutenant General John Frewen, head of the vaccination task force, told broadcaster ABC.

Source: https://www.msn.com/en-us/news/world/pfizer-covid-vaccines-arrive-in-australia-under-uk-swap-deal/ar-AAO8pUG

On 6 September it was also reported that 450,000 (instead of 290,000 doses) from the UK had arrived in Australia in the evening on Sunday, 5 September. The plane had stopped in Darwin before it arrived in Sydney.

International agreements (comparison).

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.

Terms of supply

Although not confirmed by The Australian government, it appears that the general Pfizer supply agreements specify a number of doses, rather than the number of physical vials they will be delivered in.

As a practical matter there has to be agreement on the number of doses that are to be agreed as ‘delivered’ in each multi-dose vial.

In the latter part of 2020, it appears that Pfizer and its clients thought that it would need to supply a certain number of vials, trays and boxes based on the premise that 5 doses per vial would be achievable. This is likely to have been because 5 doses could be achieved using standard syringes.

However, by 6 January 2021, in the United States at least, there was agreement that Pfizer’s vials could contain 6 useful doses, provided sufficient low air-gap syringes could be used to make up most of the diluted doses. This was reported by international news service, Politico.

In effect, Pfizer would now be able to deliver more doses using the same manufacturing process, and it would then fall to the recipients to ensure they tried to extract 6 doses rather than 5 from each multi-dose vial.

Contractual versus 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

The reason that Minister Hunt might have said ‘when we ordered, we based that on the foundation of five”, is that he was referring to the likely position in 2020 – that there were supposed to be 5 doses supplied per vial, and no more.

However, if by 2021, Pfizer had agreed with the Australian government that each vial was now a supply of 6 doses (this required Australia to source better syringes), then it was no longer a ‘bonus’ to be obtaining 6 doses – it was the expected number of doses that Pfizer was to supply, and presumably, they would be paid for all of them. Rather than 6 doses being a bonus, 5 doses would be a loss.

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 was also the agreed contractual basis on which Pfizer was 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.

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

Details of Australia’s payments for COVAX

The state of Australia’s access to the COVAX facility has been updated at the Health Department’s web page for Australia’s vaccine supply agreements. As at 17 August 2021, this contained further details about what transpired in June 2021. It appears that on 3 June 2021, shortly before Australia gained access to the 500,000 doses, it made a further contribution of $50 million dollars. It is not clear if this was a further payment to accelerate our opportunity for access to the supply of COVAX vaccines.

As explained at that website, it appears Australia has entered into some kind of fixed price purchase option to allow the future purchase of COVID vaccines that are inside the Gavi COVAX facility. The details there, however, are limited to this statement:

Australia’s commitments to the COVAX Facility

The Government has made two financial commitments to Gavi’s COVAX Facility for the supply of COVID-19 vaccines:

An upfront payment of $123.2 million to allow the purchase of over 25,000,000 doses of COVID-19 vaccines for the Australian population. This is enough for 50 percent of the population to receive 2 doses.

On 26 August 2020, Australia announced an investment of $80 million to the Advanced Market Commitment (AMC) of the COVAX Facility and on 3 June 2021, Australia contributed an additional $50 million, making a total of $130 Million to the COVAX AMC.

Excerpt from Health Department’s COVID vaccine supply agreements web page, accessed 17 August 2021.

Australia’s drawdowns on the COVAX facility

In June 2021, Australia’s use of the COVAX facility was linked to the supply of 500,000 doses that were part of an 811, 890 dose release. This was linked to Pfizer, rather than the Gavi facility directly. The circumstances under which Australia obtained access to COVAX is not clear.

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

There was no weekly Vaccine Operations update report for 7 June, but the next one, on 14 June 2021, refers to the release of 811,980 doses.

On 17 August 2021 there was an article in the Daily Mail (by Peter Vincent) which identified that exactly 513,630 doses were received. There was another article on 17 August 2021 in the SMH (by Anthony Galloway) that referred to ‘about 500,000’.

The 513,630 figure is the equivalent of exactly 439 trays (at 1170 doses per tray, equivalent). It is not clear whether this number was obtained from direct information, or whether it has been deduced as the balance of the weekly supply (298,350 doses) at that time.

Based on the Daily Mail information (17 August 2021) that the COVAX amount was 513,630 we can infer that the breakdown of 811,980 released doses announced in June was as follows:

SourceDosesTrays (1170 dose equivalent)
Pfizer contract298,350255
COVAX supply513,630439
Total (June 2021)811,980694
Reconciliation of announcements ~ 10 June 2021 with actual Pfizer supply

This is consistent with the 298,350 doses that had been disclosed as the weekly delivery doses for the previous week, on 31 May 2021.

The implication of Australia obtaining 500,000 doses (equivalent) in about early June 2021 is that it was unable to acquire more from elsewhere, that this was the limit of what it wanted to, or could obtain from the COVAX facility. Presumably, this also required reconciliation with the payments (above), for example by attributing a per unit cost of say $5 per dose to the drawdown of vaccines from COVAX.

Do the COVAX facility vaccine doses appear in the TGA batch listing?

At this stage, it is difficult to tell, but based on the announcements, it appears that the vaccines would need to have completed manufacturing at Pfizer by 7 or 8 June 2021 at the latest. It is also not clear how the distribution channels for the COVAX facility differ from the normal Pfizer manufacturing process (if at all).

In terms of date of manufacture, the announcement of COVAX doses are close in time to the manufacture date of the Pfizer batch 7 June 2021 (FD0927) that the TGA apparently did not need to test because there was an earlier batch of FD0927 delivered around end of May 2021.

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.

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.

The arrival of the first delivery (to Sydney, on a Singapore Airlines flight) was captured for commercial news content by Australian media.

  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 information has to be pieced together from scarce details, incrementally.

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 date on the TGA Batch Release web page 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 last 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 25 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.

Pfizer Australia employees receive special July release

Several batches of Pfizer vaccine, manufactured in June 2021, was delivered to Australia no later than 5 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)

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. I have aligned the 300,690 doses (equivalent to 257 trays) that were announced as released to the second delivery of batch FE3064 (since FC5029 is still ‘in progress’).

It is likely some of the details for the March to June will need further analysis and updates.

The TGA batch release web page as at 25 July 2021 was 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 5 July 2021 at the latest, which would suggest that they have already been approved for release at that time.

Reconciliation of announcements to TGA Batches as at 5 July 2021

This section updated 25 July 2021.

My reconciliation of TGA Pfizer batch releases to announced deliveries (ongoing work).

July information about bringing forward Pfizer contractual deliveries

This section updated 4 August 2021.

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. In that article, the Pfizer representatives are quoted as meeting a weekly delivery schedule, with a delivery due on or about 19 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.

On 11 July 2021, Lieutenant General John Frewen stated in a press conference that there would be increased Pfizer doses:

QUESTION:                           

So, is this essentially an admission that you can’t be encouraging everyone to rush because there aren’t quite enough vaccines for everyone to do that yet? And will you be having more talks internationally about sourcing extra vaccines, as is being suggested today?

JOHN FREWEN:                    

So we are constantly working to bring forward vaccines where we can. You will have seen last week, a few weeks ago we were getting 300,000 doses of Pfizer a week into the country. In the next few weeks, that will go to around about a million doses a week. So that’s a very significant increase, that’s bringing forward of doses that we did have ordered that we were anticipating later in the year. That’s a very positive development. It’s been very welcomed by the jurisdictions. That will help people get access to Pfizer earlier.

Excerpt from Press Conference 11 July 2021, published by Health Department 12 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

On 19 July 2021, on ABC Radio, General Frewen accepted the journalist’s premise in the request to  “get more [information] now on the arrival of almost a million doses of Pfizer vaccine overnight to help boost the national rollout” (information that appears to have been conveyed prior to the interview).

On 19 July 2021, on television, LG Frewen stated there would be about 1 million doses a week:

JOHN FREWEN:     

Nat, as quickly as we can. We’ve had two really great pieces of news in the last few days. Over the weekend, we’ve hit the 10 million doses have been administered in Australia mark, and then this news about a million doses a week, at least out until the end of August. So we’re moving as fast as we can to get them into people’s arms.

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.

23 July 2021 statements about Pfizer arrival

This section created 2 August 2021.

On a television program, Health Minister Hunt made the following statements about the increased Pfizer supply “arriving in the last week”:

NATALIE BARR:

So, one of the biggest questions we get here on Sunrise, I think, is when is Pfizer going to be available to the under 40s? Have you got any news on that?

GREG HUNT:

Yes. So, the expectation at this stage is September, early October. We’ve just increased our Pfizer from over 500,000 a couple of weeks ago to a million, which has arrived in the last week.

That’s what we’re expecting to receive per week over the period from now until the end of September, and then it will increase again. So, that’s the expectation at the moment.

Excerpt from television interview transcript, 23 July 2021. URL: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/interview-with-natalie-barr-on-sunrise-about-approval-of-pfizer-vaccine-for-12-15-year-olds-and-the-vaccine-rollout

23 July 2021 Television Interview Transcript

26 July 2021 statements about Pfizer supply to NSW

This section created 2 August 2021.

On 26 July 2021, at a press conference, Health Minister Hunt gave this response in answer to a question by a journalist who had asked about where additional doses of Pfizer for New South Wales were coming from:

JOURNALIST:

So can you clarify is there a national stockpile of Pfizer? Where are these extra doses coming from?

GREG HUNT:

So, these were previously unallocated doses.

The first 150,000, the 50,000 is coming forward from the supplies that are arriving and all state and territories are receiving exactly the per capita amount, which was pledged at the commencement of July.

So what we’ve been able to do by bringing forward these increasing doses, as we know, we brought forward three million over the course, we’ve been able to meet all of the commitments to states and territories. And this is from the additional supplies that we’ve been able to secure.

But what we have done is make sure we’re not holding large amounts of doses. There’s always a choice. If we were holding doses, people would say they should be out. If we aren’t holding doses, people are saying, why not? The simple answer is we make sure we have the second doses.

We also make sure that everything that possibly can be distributed each week is distributed. So these additional doses, the 150,000 was previously from the unallocated. The extra 50,000 is from the forward supplies that are arriving. And all states and territories are receiving a per capita increase, precisely in line with the figures that were set out previously.

Excerpt from transcript of press conference on 26 July 2021. URL: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/press-conference-in-melbourne-on-26-july-2021-with-an-update-on-the-covid-19-vaccine-rollout

26 July 2021 Press Conference Transcript

27 July 2021 update on Pfizer releases

On 26 July 2021, the first ‘weekly’ Vaccine Operations Centre update since 12 July occurred. The update was published on the government website on 27 July 2021.

Vaccine Operations Update 26 July 2021

The statement includes this information:

Last week, around 1 million doses of Pfizer were released for distribution.
Over the coming week, the Therapeutic Goods Administration will conduct sample testing of over 1 million doses of Pfizer vaccine, along with over 1.6 million doses of AstraZeneca vaccine produced onshore by CSL, prior to releasing the vaccines for distribution.

Source: https://www.health.gov.au/news/vaccine-operations-centre-weekly-operational-update-26-july-2021 (available 27 July 2021)

There are no details of any new shipment arrival dates with this announcement, but it appears that the weekly delivery occurred over the weekend.

As at 4 August 2021, it is not possible to confirm this release with the public TGA Batch release information, which remains dated 5 July 2021.

Belated 19 July 2021 Vaccinations Centre Operations Report

This section created 2 August 2021.

On or about 28 July 2021, the Vaccinations Operation Centre published its backdated 19 July 2021 operations report on the Health Department web site.

19 July 2021 Vaccinations Operations Centre report (published ~ 28 July 2021)

It is not clear whether there was any official public media conference with this information. The announcement referred to the previous 500,000 doses being released:

Last week, over 500,000 doses of Pfizer and 500,000 doses of AstraZeneca were released for distribution.

Over the coming days, the Therapeutic Goods Administration will conduct sample testing of close to 1 million doses of Pfizer vaccine, prior to releasing the vaccines for distribution.

Excerpt from 19 July 2021 Vaccinations Centre Operations Report

The TGA, for its part, has not (as at 2 August 2021), updated its batch release website information since 5 July 2021, and at that time, the latest release information on the web page was dated 29 June 2021. In contrast, the TGA continues to provide updated weekly safety reports on another web page.

29 July 2021 Radio Interview

On 29 July 2021, Health Minister Hunt gave an interview on commercial radio where he stated that the original supply of Pfizer at this time of year was supposed to be 600,000 per week:

Well, the supplies were always coming at, at this time, but instead of 600,000 Pfizer a week we’re now getting a million. We were expecting 600,000 at this time, we’ve been able to bring it forward. And obviously, the AstraZeneca advice had reduced that pool.

per Minister Hunt, Radio Interview, 29 July 2021. URL:https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/interview-on-6pr-with-liam-bartlett-regarding-the-national-covid-19-vaccine-roll-out-update

29 July 2021 Interview Transcript

3 August 2021 Vaccine Operations Report

Expected 3 August 2021. Not yet published on Health Dept Web Site (as at 4 August 2021).

On or about 6 August 2021, the Vaccine Operations Report dated 2 August 2021 was published. This report stated that last week, over 1 million doses were released, and over 1 million doses would be tested for release in the coming week. As at 7 August 2021, the TGA Batch Release information has still not been updated since 5 July 2021.

11 August 2021 TGA Batch Release website update

The TGA updated its batch release website on or about 11 August 2021. The only substantial change since 5 July 2021 was the inclusion of these additional batch numbers:

Batch ReferenceBatch completed dateStatus
FG005027 July 2021In progress
FA459830 July 2021Not tested
FE81633 August 2021In progress

The status of FC5029 (in progress), a recent batch dated 29 June 2021, did not change in the 11 August 2021 update.

Batch FA 4598 was apparently not tested, because it is the same batch number as the 22 June 2021 batch that was released for Pfizer employees.

On 11 August 2021 there was insufficient information to reconcile the announced deliveries at the beginning of July 2021 with these batches.

12 August 2021 TGA Batch Release webpage update

On or about 12 August 2021 the TGA web page was updated to include information for 4 more batch releases for the first few weeks of July:

Batch ReferenceBatch completed dateStatus
24FF42226 July 2021Passed
25FE343014 July 2021Passed
26FF088415 July 2021In Progress
27FF887121 July 2021In Progress
Pfizer batch numbers for delivered supply, as published by TGA to 12 August 2021

Anticipated delivery of an additional 1 million Pfizer vaccines ~ 15 August 2021

On 15 August 2021, the Prime Minister announced that he had obtained another 1 million (approximately) doses from Poland, that had already departed from Warsaw yesterday. Approximately half of these would be sent to NSW priority areas. PM. ABC News.

StateDosesTrays (1170 doses equivalent)Percent
NSW53001045353.0
VIC17550015017.5
QLD13689011713.7
SA47970414.8
WA70200607.0
TAS17550151.8
NT819070.8
ACT 14040121.4
Total1000350855100.0
Announced doses due to arrive and announced allocations by State

Remember, if only 5 doses are obtained from each vial, instead of the 6 assumed by the numbers quoted above, then the total vaccines put into circulation by the above order is only 833,625 doses, not the maximum possible 1,000,350.

Today’s media release also states, in part:

These additional one million come on top of the three million doses of Pfizer brought forward from the fourth quarter to now, which has increased the weekly arrivals of Pfizer from 600,000 to one million per week.

Extract from 15 August 2021 media release by the Prime Minister’s Office. https://www.pm.gov.au/media/one-million-doses-pfizer-vaccine-europe-boosting-australian-supplies

The 3 million is the same that Minister Hunt referred to on 18 July as being brought forward from the fourth quarter. Australia’s Pfizer vaccine supply from Pfizer directly will now drop back, by necessity, under the original agreement.

Today’s announcement also confirms that in order to obtain more Pfizer doses in the short term, the government is left trying to do so through diplomatic channels. Australia is apparently left pursuing diplomatic channels to source additional Pfizer because the government has exhausted its previous variations from its direct supply agreement with Pfizer.

Poland itself had been receiving an extra 1 million doses per week from Pfizer, but on or about 16 June 2021 it was reported that Poland would no longer be receiving those extra doses. Subsequently, it was reported (July) that Poland would be selling its unwanted doses.

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