Briefing
Securing additional doses of Pfizer’s COVID-19 vaccine in September
Date due to MO: 4 September 2021
Action required by:
5 September 2021
Security level:
Commercially Sensitive
Health Report number: HR20211964
To:
Rt Hon Jacinda Ardern, Prime Minister
Hon Grant Robertson, Minister of Finance
Hon Chris Hipkins, Minister for COVID-19 Response
Copy to:
Hon Nanaia Mahuta, Minister of Foreign Affairs
Contact for telephone discussion
RELEASED
Name
Position
Telephone
Dr Ashley Bloomfield
Director-General of Health
s 9(2)(a)
Jo Gibbs
National Director, COVID-19 Vaccine and
s 9(2)(a)
Immunisation Programme
Minister’s office to complete:
☐ Approved
☐ Decline
☐ Noted
☐ Needs change
☐ Seen
☐ Overtaken by events
☐ See Minister’s Notes
☐ Withdrawn
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Comment:
COVID-19 Vaccine Strategy – Securing additional doses of Pfizer vaccine in
September
Security level:
Commercially Sensitive
Date:
3 September 2021
To:
Rt Hon Jacinda Ardern, Prime Minister
Hon Grant Robertson, Minister of Finance
Hon Chris Hipkins, Minister for COVID-19 Response
Copy to:
Hon Nanaia Mahuta, Minister of Foreign Affairs
Purpose of report
1.
To seek your agreement to enter into two bilateral agreements with Denmark and Spain
for the purchase of up to 774,000 doses of Pfizer’s COVID-19 vaccine to support the
COVID-19 Vaccine Immunisation Programme (CVIP) in September 2021.
Summary
2.
There has been a significant increase in demand for COVID-19 vaccines over the last two
RELEASED
weeks in response to the recent COVID-19 outbreak and subsequent Alert Level change
and expanding vaccine eligibility within the programme to those aged 12 and over.
3.
The vaccination rate has recently surpassed 535,000 vaccinations per week (77,000 per
day). If vaccine uptake is maintained at the current rate, we risk disruption to the CVIP in
mid-September as a result of a vaccine supply gap of approximately 750,000 doses.
4.
New Zealand has an option to purchase up to 774,000 doses of Pfizer vaccine through
bilateral agreements with Denmark and Spain, with 274,000 of those doses being
delivered to New Zealand as early as 11 September 2021, with distribution to DHBs and
vaccination centres to follow thereafter.
5.
To ensure these doses can arrive within a timeframe that is beneficial to the CVIP, the
Ministry has arranged its own transportation, and the doses will be imported by the
Crown.
6.
As such, the importation of these doses is subject to approval by the Director-General of
Health under section 32A of the Medicines Act 1981 and the Crown will be responsible
for meeting a number of requirements in relation to the provisional consent for the
Pfizer vaccine and responding to any potential product quality issues.
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7.
A logistics plan is in place, which follows international best practices and procedures to
ensure that the vaccine doses arrive in New Zealand safely.
8.
The Minister of Finance has been asked to grant indemnities in favour of Spain and
Denmark under the bilateral agreements, and two indemnities in favour of Pfizer and
others under related documents.
9.
We are recommending that Vaccine Ministers invite the Director-General of Health, on
behalf of the Crown to sign bilateral agreements with Denmark and Spain.
Briefing: HR20211964
1
Recommendations
We recommend you:
a)
Note that we continue to face immediate vaccine supply pressure due to increased
demand for vaccines following the current COVID-19 outbreak.
b)
Note that officials have explored several avenues to secure additional supply in
September, ahead of the large shipments expected from Pfizer in October.
c)
Note that up to 774,000 doses of the Pfizer vaccine are available for resale from a
combination of EU member states (Denmark and Spain) for delivery in New Zealand
as early as 11 September 2021.
d)
Note that New Zealand is required to co-ordinate pick-up and transport of the
vaccine from the selling countries to facilitate a timely delivery to support the
COVID-19 Vaccine Immunisation Programme.
e)
Note that officials, with the support of external legal counsel Bell Gully, have
finalised forms of bilateral agreements with each of the selling countries.
f)
Note that in August 2021, Cabinet [CAB-21-MIN-0350 refers]:
i.
agreed to increase the tagged contingency “Minimising the health impacts of
COVID-19 – Tagged Operating Contingency” by an additional s 9(2)(b)(ii) to
secure supply of an mRNA vaccine (including any additional purchases for 2021);
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and
ii.
authorised Vaccine Ministers to draw down on the tagged operating
contingency funding.
g)
Agree that, if all outstanding regulatory matters are resolved, the Director-General
Yes/No
of Health, on behalf of the Crown, will sign the bilateral agreements (with the
exception of the provisions relating to indemnities) to secure an additional 750,000
doses of Pfizer vaccine.
h)
s 9(2)(b)(ii)
Yes/No
i)
Agree subject to your agreement to recommendation g) above, to draw down
Yes/No
s 9(2)(b)(ii)
from the ‘Minimising the health impacts of
COVID-19 – Tagged Operating Contingency’ to purchase up to an additional
774,000 doses of Pfizer’s vaccine.
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Briefing: HR20211964
2
j)
Approve if you agree to the recommendation i) above, the following changes to
Yes/No
the appropriations to provide for the decision, with a corresponding impact on the
operating balance and net core Crown debt as follows:
Vote Health
$m – increase/(decrease)
Minister of Health
2024/25
2021/22
2022/23
2023/24
&
Outyears
Multi-Category
Expenses and Capital
Expenditure:
Implementing the
COVID-19 Vaccine
s 9(2)(b)(ii)
Strategy MCA
Non-Departmental
Output Expense:
Purchasing Potential and
Proven COVID-19
Vaccines and Other
Therapeutics
k)
Agree that the changes to appropriations for 2021/22 above be included in the
Yes/No
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2021/22 Supplementary Estimates and that in the interim the increase be met from
Imprest Supply.
l)
Agree that the expiry date for the “Minimising the health impacts of COVID-19”
Yes/No
Tagged Operating Contingency be 1 February 2023.
m)
Note that transport costs are additional to the price per dose in these bilateral
agreements and have not yet been finalised (estimated to be around NZD
s 9(2)(b)(ii) These costs will be covered by the by existing funding arrangements.
n)
Note that Treasury officials are separately seeking agreement from the Minister of
Finance to the indemnities in favour of Spain and Denmark included in the bilateral
purchase agreements and indemnities in favour of Pfizer and others included in
related documents (Treasury Report 2021/2212 refers).
o)
Note that if the Minister of Finance agrees to grant all indemnities, then he will be
invited to co-sign the bilateral agreements in respect of the indemnities in favour
of Spain and Denmark, and sign related documents containing indemnities in favour
of Pfizer and others.
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p)
Note that importation and distribution of the vaccine by the Crown is subject to
approval by the Director-General of Health under section 32A of the Medicines Act
1981; and New Zealand will not be in a position to enter the bilateral agreements
unless and until that approval is granted.
q)
Note that the Crown (rather than Pfizer) will be importing these doses and
accordingly the Crown will have obligations under the Medicines Act 1981 in
relation to these doses.
Briefing: HR20211964
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r)
s 9(2)(b)(i), s 6(b)(i)
s)
Note that subject to your agreement to recommendation g), the Director-General
signing the bilateral agreements, and the Minister of Finance signing the bilateral
agreements and related documents:
i.
they will be shared with Denmark and Spain for countersigning. As part of
this process, the selling country must inform Pfizer of the resale deal which
could take 48 hours;
ii.
once the agreements have been executed, New Zealand can pick up the
doses and transport them to New Zealand.
t)
Note that officials recommend a phased communications approach to reflect the
amount of certainty at a given time:
i.
at this stage communicating we are in negotiations with a number of
countries to secure additional doses
ii.
signalling that we have secured additional doses from Spain and Denmark
for September once bilateral arrangements have been executed
iii.
making an announcement upon receipt of the initial doses.
RELEASED
u)
Note the purchase of these additional doses mean that from October we are likely
to have an oversupply of vaccines and officials will provide further advice on the
impacts of our delivery schedule in 2021, including options to minimise wastage.
Rt Hon Jacinda Ardern
Hon Grant Robertson
Prime Minister
Minister of Finance
…../…../…..
…../…../…..
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Hon Chris Hipkins
Jo Gibbs
Minister for COVID-19 Response
National Director, COVID Vaccine and
Immunisation Programme
…../…../…..
4 9 2021
…../…../…..
Briefing: HR20211964
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Securing additional doses of Pfizer’s COVID-19 vaccine in September
Background
10.
In total, we have agreed to purchase 10.1 million doses of Pfizer’s COVID-19 vaccine for
delivery in 2021, which has enabled the rollout of New Zealand’s COVID-19 Vaccine
Immunisation programme (CVIP) to date.
11.
These doses are sufficient to fully vaccinate all eligible population groups this year
(currently 4.2 million people). However, there has been a significant increase in demand
for COVID-19 vaccines over the last two weeks in response to:
a. the recent COVID-19 outbreak and subsequent Alert Level change; and
b. expanding vaccine eligibility within the programme to those aged 12 and over.
12.
The vaccination rate has recently surpassed 535,000 vaccinations per week (77,000 per
day). If vaccine uptake is maintained at the current rate, we risk disruption to the CVIP in
mid-September as a result of vaccine shortages. Incorporating a safety buffer, this may
equate to a total gap in supply of approximately 750,000 doses in September.
13.
s 9(2)(b)(ii)
14.
RELEASED
The other COVID-19 vaccines in our portfolio that have already received regulatory
consent from Medsafe (AstraZeneca and Janssen) s 9(2)(b)(ii)
15.
However, supported by the Prime Minister’s engagement with her counterparts, the
governments of Spain, and Denmark have confirmed that, between them, they can
supply us with up to 774,000 doses of Pfizer vaccine in September. Further information is
outlined below in table 1.
Table 1. Summary of Resale Offers
Source
Vaccine
Volume
Availability
Location
Manufacturing
country
(doses)
source (site)
Spain
Pfizer
16.
274,000
As early as 11
Madrid
Pruus, Belgium
September
Denmark
Pfizer
Up to
Across the
Copenhagen
Pruus, Belgium
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500,000
weeks of 13
September
and 20
September
Officials are finalising agreements with the selling countries
17.
To confirm the purchase of these vaccines, New Zealand is required to enter into
bilateral resale agreements with both Denmark and Spain.
Briefing: HR20211964
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18.
s 6(b)(i), s 9(2)(ba)(i)
19.
20.
21.
22.
These doses will be available for use in the programme from mid-
September
23.
Officials are awaiting confirmation from Pfizer that all additional doses are identical to
the doses secured under our advance purchase agreement with Pfizer, including
labelling. If this confirmation is obtained, the additional doses will be within the scope of
RELEASED
the existing Medsafe provisional consent. Provided that the Crown can verify on arrival in
New Zealand that the doses remained within temperature profile specifications, and can
provide independent batch certification for the additional doses, they can be
incorporated seamlessly into the CVIP once they arrive in New Zealand. If there are any
differences between the additional doses and the product approved by Medsafe,
officials will seek advice from Medsafe regarding the implications.
24.
There is sufficient Ultra Low Temperature storage, and adequate consumables (including
needles, syringes, and diluent) available to support the immediate use of these
additional doses in the programme.
25.
Our estimated overall Pfizer vaccine delivery schedule, including these additional doses,
is as follows:
s 9(2)(b)(ii)
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Briefing: HR20211964
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26.
Existing scheduled deliveries from Pfizer will continue to arrive weekly, with significant
deliveries due to begin on 2 October.
Risks and Assurances
New Zealand has arranged transportation of these doses from the selling countries
27.
s 9(2)(b)(ii)
28.
As a result, the Ministry has arranged transportation (including thermal shippers and
data loggers) to deliver 274,000 doses from Spain as early as 11 September, and the
remaining 500,000 doses from Denmark split across the week of 13 September and the
week of 20 September.
s 9(2)(b)(ii)
29.
s 9(2)(b)(ii)
30.
As such, the importation is subject to the approval by the Director-General of Health
under section 32A of the Medicines Act 1981 (the Act). This approval has the effect of
RELEASED
exempting the Crown from compliance with certain provisions of the Act. The Crown will
have some obligations under the Act in relation to these doses, including:
a. ensuring that these doses are within the scope of the existing provisional consent
b. complying with requirements regarding containers and packaging; and
c. complying with record keeping obligations.
31.
s 9(2)(b)(ii)
32.
The Crown, as the importer of these doses, will need to respond to any actions
requested by Medsafe if product quality issues arise in relation to these doses. A
potential risk is that the Crown may not have the necessary information to respond to
Medsafe, and the Crown has no contractual right to obtain the information from Pfizer.
s 9(2)(b)(ii), s 9(2)(b)(i), s 6(b)(i)
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Briefing: HR20211964
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s 9(2)(b)(ii), s 9(2)(b)(i), s 6(b)(i)
A logistics plan is in place to ensure the vaccine arrives in New Zealand safely
35.
The vaccine doses will be shipped from Pfizer’s manufacturing site to storage sites in the
member states. These storage sites are the equivalents of Healthcare Logistics in New
Zealand.
36.
The vaccine doses will then be packed into approved boxes in line with Pfizer and
international best practices and procedures to ensure that the vaccine remains within the
acceptable temperature specifications. Data loggers will be used to monitor
temperatures at all times during storage and transportation.
37.
The Ministry of Health will obtain quality assurance documentation from each of the
storage sites, which will be assessed by Medsafe to ensure the quality of the vaccine
doses has been maintained.
38.
Upon arrival, the vaccine doses will undergo the standard batch release process before
being repacked and distributed for use in the CVIP.
Officials recommend, on balance, that Vaccine Ministers should agree to the purchase of these
additional vaccine doses
39.
The Ministry of Health has worked closely with the Ministry for Foreign Affairs and Trade,
the Treasury, and been supported by legal advice from Bell Gully to ensure that the
terms and conditions of this purchase are acceptable.
RELEASED
40.
On 30 August, Cabinet agreed to progress negotiations with vaccine suppliers for
additional vaccines to ensure that the portfolio continues to support immunisation
needs in New Zealand and the Pacific. Cabinet delegated any future purchasing
decisions to Vaccine Ministers [CAB-21-MIN-0350 refers].
41.
We are recommending that Vaccine Ministers invite the Director-General of Health, on
behalf of the Crown to sign (with the exception of the provisions relating to indemnities)
the bilateral agreements with Denmark and Spain.
42.
The Minister of Finance will co-sign the bilateral agreements alongside the Director-
General of Health in respect of the indemnity provisions in favour of Spain and Denmark,
and will sign related documents containing indemnities in favour of Pfizer and others.
Indemnities are required
43.
The bilateral agreements to purchase these doses require four indemnities to be granted
by the Minister of Finance; indemnities in favour of Spain and Denmark under the
bilateral agreements, and two indemnities in favour of Pfizer and others under related
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documents. The Minister of Finance has been asked to grant these indemnities under
section 65ZD of the Public Finance Act 1989 [Treasury Report 2021/2212 refers].
s 9(2)(b)(ii)
Briefing: HR20211964
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s 9(2)(b)(ii)
Equity
46.
Ongoing access to COVID-19 vaccines is essential to maximise uptake, particularly in a
period of increased interest in being vaccinated following the recent outbreak.
47.
Eligibility within the programme has recently expanded to include under 30s, where
there is a large proportion of Māori and Pacific people, so available supply is essential to
enable high levels of uptake in this group.
48.
Pacific populations have been most affected by the recent outbreak of COVID-19 in the
community, making up a disproportionate percentage of cases and hospitalisations.
49.
Ensuring that the CVIP can progress at as high a rate as possible during this time period
is crucial to ensure that vulnerable populations can be protected from COVID-19.
This purchase will continue to support New Zealand’s role as a contributor to the global response to the
pandemic
50.
Securing these doses not only enables the continuation of our domestic CVIP, but also
provides greater certainty of supply to enable earlier donation of doses to Realm
RELEASED
countries and the wider Pacific.
51.
s 9(2)(b)(ii)
52.
This collaboration with EU member states also supports their efforts to not waste
vaccine, maximising the utility of every dose and supporting global coverage.
53.
These additional doses mean that from October we are likely to have an oversupply of
vaccines for those currently eligible. The focus of the CVIP will be on further increasing
uptake and minimising wastage, and if evidence supports, a booster programme and
increasing eligibility.
54.
Further, officials will progress discussions to enable donation pathways as an option for
minimising wastage and ensuring the New Zealand continues to play a role as a
significant contributor to the global response to COVID-19.
55.
Separate advice is being provided by officials on reprofiling Pfizer volumes for Q4 of
2021 (HR-20211981 refers).
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56.
s 9(2)(g)(i), s 6(a)
Briefing: HR20211964
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We recommend drawing down funding from the tagged contingency to
meet the cost of the purchase
57.
s 9(2)(b)(ii)
58.
On 30 August Cabinet agreed to increase the tagged contingency “Minimising the
health impacts of COVID-19 – Tagged Operating Contingency” by an additional s 9(2)(b)(ii)
(including any additional purchases for
2021) [CAB-21-MIN-0350 refers], and authorised Vaccine Ministers to draw down on the
tagged operating contingency funding.
59.
s 9(2)(b)(ii)
60.
The costs associated with transportation of the vaccines are additional to the price per
dose in these bilateral agreements and have not yet been finalised. Current estimates are
total costs will be approximately s 9(2)(b)(ii)
which will be absorbed by current
funding appropriated to the CVIP.
61.
The tagged contingency is currently due to expire 1 February 2022. As Cabinet has
delegated authority to Vaccine Ministers, officials recommend that the expiry date be
RELEASED
extended to 1 February 2023 in the context of what we know currently about COVID-19
vaccine needs.
Communications
62.
Officials recommend that you take a phased communications approach to reflect the
amount of certainty at a given time. While we are concluding resale deals with the EU
and Pfizer, we can communicate that we are in negotiations with a number of countries
to secure additional doses for NZ to ensure we can maintain current rates of vaccination.
63.
Following execution of bilateral arrangements with Denmark and Spain, and acceptance
of notification by Pfizer, you could signal that we have secured additional doses from
Spain and Denmark, which will support roll out in September
64.
Upon receipt of the initial does we recommend making an announcement.
65.
All communication is required to be carried out in coordination between New Zealand
and the member state(s) under the terms of the bilateral agreements.
Next steps
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66.
Before the bilateral agreements can be entered, we will need confirmation from Pfizer
regarding product specification for the additional doses, and the approval of the
Director-General of Health pursuant to section 32A of the Medicines Act 1981.
67.
Subject to your agreement to the purchase of these additional vaccines, and the Minister
of Finance’s agreement to provide the indemnities, the Director-General of Health and
the Minister of Finance will be invited to sign, on behalf of the Crown, one bilateral
Briefing: HR20211964
10
agreement with each selling country, and the Minister of Finance will be invited to sign
the related documents containing indemnities in favour of Pfizer and others.
68.
s 6(b)(i), s 9(2)(ba)(i)
69.
Following Pfizer’s confirmation in writing, the doses are available to be transported to
New Zealand.
70.
Payments will be made within 15 calendar days of the member state issuing an invoice
under the bilateral agreements.
71.
Officials will provide further advice to Ministers on implications of potential oversupply
in October and the impact on vaccine delivery in 2021.
ENDS.
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Briefing: HR20211964
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