H202109490 Response.pdf

133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
5 August 2021
s 9(2)(a)
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 27 July 2021. I wil  respond to each part of your request in turn.
1.
A comprehensive list of all of the ingredients in the Pfizer injection.
The ingredients list for the Pfizer vaccine is publicly available here:
www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=21938.
2.
Comprehensive information about the potential benefits of the Pfizer agent -- will getting
this agent prevent my contracting COVID or transmitting COVID? Wil  it have any effect on
my immune response to the flu or other common respiratory viruses?
Information about the benefits of the Pfizer vaccine is publicly available here:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-
vaccines/covid-19-vaccine-effectiveness-and-protection; please see also
www.medsafe.govt.nz/COVID-19/q-and-a.asp.
The COVID-19 vaccine will not protect against the flu or other common respiratory viruses as
these are caused by different viruses.
3.
What are the potential adverse reactions to the Pfizer agent? As of today, how many
people worldwide and in New Zealand have reported adverse reactions, how many of
these have been major, and how many people have died?
Known side effects of the Pfizer vaccine are publicly available here:
www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf; see also www.health.govt.nz/our-
work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-
side-effects-and-reactions.
In New Zealand, adverse reactions are reported to the Centre for Adverse Reactions Monitoring
(CARM). CARM’s weekly reports on the number of adverse events following immunisation
(AEFI) in New Zealand are publicly available here: www.medsafe.govt.nz/COVID-19/vaccine-
report-overview.asp.

I am unable to provide you with global statistics on adverse reactions as this information is
not held by the Ministry. This part of your request is refused under section 18(g)(i) of the Act
as the information requested is not held by the Ministry and there are no grounds for believing
it is held by another agency subject to the Act.
4.
What are the medical contraindications to the Pfizer injection?
This information is publicly available here:
www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf; see also www.health.govt.nz/our-
work/immunisation-handbook-2020/5-coronavirus-disease-covid-19#23-6.
5.
How does the Pfizer injection differ from the fully researched and approved vaccines I
have received in the past?
Medsafe evaluates applications for all new medicines, including vaccines, to ensure that they
comply with international standards and local requirements for quality, safety and efficacy. Only
if the medicine meets these standards wil  Medsafe recommend approval for use in New
Zealand. Medsafe prioritised and streamlined the assessment process for the Pfizer vaccine in
order to reach a decision on approval sooner, but did not compromise on the integrity of this
process or on the safety requirement of the vaccine. Information about this process is publicly
available: www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp.
6.
What happens to the synthetic mRNA that is injected into a person? Where does it go and
how long does it stay within the body?
7.
Where does the spike proteins travel within the body -- does it cross the blood-brain
barrier? Can the spike proteins cause damage on its own? Can this protein trigger an
autoimmune response towards vital organs? Is it linked to blood clots? Can the spike
proteins be eliminated thoroughly and safely from the body?
Information on how the Pfizer vaccine works is publicly available here:
www.medsafe.govt.nz/COVID-19/mRNA-vaccines.asp. The mRNA is broken down by the body
shortly after vaccination. Animal studies showed that the mRNA in the Pfizer vaccine is broken
down within a couple of weeks.
Information on how spike proteins work is also publicly available. Here are some resources
which you may find useful:
www.epa.govt.nz/community-involvement/science-corner/sars-cov-2-vaccines-and-the-hsno-
act/.
www.nebraskamed.com/COVID/where-mrna-vaccines-and-spike-proteins-go.
The number of reports of blood clots after vaccination is lower than the base rate of blood clots
in the general population.
8.
What happens to the lipid nanoparticles that appear to be a part of the Pfizer agent?
Where do they travel within the body? What are the potential adverse effects of having
these particles within the body? Can they be eliminated?
Animal studies have indicated that the lipid nanoparticles which contain the mRNA rapidly leave
the bloodstream in the first 24 hours following administration. Most of these then are transported
to the liver. They are broken down by the body within 2 to 6 weeks. This information is publicly
available here: www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-
assessment-report_en.pdf.
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9.
Who wil  assume liability if I develop an adverse reaction? Pfizer? The government? My
employer? You?

The Accident Compensation Corporation (ACC) can provide treatment and support for injuries
caused by COVID-19 vaccination if the criteria for treatment injury are met. This means there is
a physical injury caused by the vaccination, that is not a necessary part or ordinary
consequence of the treatment. For more information see the ACC website: www.acc.co.nz/for-
providers/lodging-claims/lodging-a-claim-for-a-patient/#information-for-specific-injury-types.

10.  I understand that the Pfizer injection is only authorised under provisional consent -- so that
questions of long-term efficacy and safety have not yet been answered - am I correct in
this?

The Pfizer vaccine has been granted provisional consent for a period of nine months. This
allows a number of conditions to be placed on the consent that require the sponsor company to
provide additional information and conduct certain activities. At the end of this period, the
vaccine may be given full consent, given renewed provisional consent for a further period of
time, or the consent may not be renewed. This decision wil  be made after review of the
additional information provided to Medsafe by the company since provisional consent was
initially granted. Medsafe has assessed safety and efficacy data from the six-month follow up
point in the pivot clinical trial. This and other clinical studies are currently ongoing, which is
normal for a new vaccine.

If so, do you believe, as my doctor, that I should receive this agent without such data
available?
11.  If I contract COVID after having received the Pfizer agent, how would you treat me?

While the Act enables people to request official information from the Ministry, it only applies to
information it holds. There is no obligation to create information or compile information it does
not hold in order to respond to requests, nor is the Ministry obliged to provide or prove an
opinion. Therefore, this part of your request is refused under section 18(g)(i) of the Act, as the
information requested is not held by the Ministry and there are no grounds for believing it is held
by another agency subject to the Act.

If you have concerns, I encourage you to discuss these with your doctor.

12.   If I become il  after the Pfizer injection, how wil  you be able to tell that it is caused by the
Pfizer injection? Wil  you automatically report any symptoms/adverse effects that I wil
experience to CARM?

It difficult to establish a causal relation between il ness or reactions experienced following any
vaccine as there are many individual factors at play. Any adverse reactions you experience after
receiving the Pfizer vaccine and which you suspect may be linked to your vaccination can be
reported to CARM. Your health professional is encouraged to report these on your behalf,
although they are not legally required to do so. You are also encouraged to lodge a report
yourself. For more information on reporting adverse reactions see:
www.medsafe.govt.nz/COVID-19/monitoring-process.asp.

13.  Are you aware of early treatment protocols for COVID, such as Ivermectin,
hydroxychloroquine, zinc, steroids, Vit-D and other medications? Would you be wil ing to
prescribe these agents if I were to contract COVID?

At present, the only approved medication for COVID-19 is dexamethasone tablets. Medical
practitioners are permitted to use any medicine for a particular patient in their care at their
discretion; however, unapproved medicines have not been evaluated by Medsafe for safety and
efficacy. If your healthcare professional chose to prescribe any of the mentioned agents to treat
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a patient with COVID-19 it would be their responsibility to ensure that they are aware of any
safety issues and that they communicate the risks and benefits to their patients. See
www.medsafe.govt.nz/COVID-19/medicine-approval-process.asp.

14.   If I have no symptoms of a respiratory virus, do you believe I can infect others, and if so,
how?

Flu viruses are well-known to be infectious prior to the development of symptoms. Please see:
www.cdc.gov/flu/about/disease/spread.htm.

15.  How dangerous is COVID compared to other common respiratory viruses such as the flu?
Can you provide me with some epidemiologic data?

Information on how COVID-19 and influenza viruses differ can be found here:
www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-
detail/coronavirus-disease-covid-19-similarities-and-differences-with-influenza.

16.   If I agree to receive the Pfizer injection, wil  it protect me fully if I am exposed to any
variant, current and future, of COVID?

This information is publicly available here: www.medsafe.govt.nz/COVID-19/q-and-a.asp.

17.  If I have already been exposed to the virus, do I really need the Pfizer injection, and If I
do, is there a risk of getting more sick if I am re-exposed again to the virus? I wil  assume
you are aware of the New Zealand Bil  of Rights and the Nuremberg Code, which stipulate
that a person has a right to refuse medical interventions. Even if a COVID vaccine is
developed and fully approved, wil  you respect my right to decline an invitation to receive
it?”

This information is publicly available at the following link: www.medsafe.govt.nz/COVID-19/q-
and-a.asp. Additionally, it is not mandatory to be vaccinated against COVID-19.

I trust this information fulfils your request. Under section 28(3) of the Act you have the right to
ask the Ombudsman to review any decisions made under this request. The Ombudsman may
be contacted by email at: [email address] or by calling 0800 802 602.

Please note that this response, with your personal details removed, may be published on the
Ministry website at: www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.

Nāku noa, nā

Clare Perry
Deputy Director-General
Health System Improvement and Innovation

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