Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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References

Visible links
1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

Kia ora,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202116287.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [2][email address]

 

show quoted sections

Kia ora R,

 

Thank you for your request for official information, received on 15
November 2021 for:

 

"… any documents you have regarding the Pfizer mRNA vaccines that include
information regarding the production of spike proteins in the body post
vaccination including, but not limited to, duration of production by human
cells (i.e. how long are they produced by the body), spike protein
production amounts (i.e. how many mg of protein will be produced? How many
individual proteins will be created?)"

 

The Ministry has identified a large amount of information within scope of
your request. However, this is made up of regularly updated versions of
the same document. Would you agree for the Ministry to provide you with
only the most recent version of this document, rather than include all of
the previous versions of this document in the response?

 

We look forward to receiving your response.

 

Ngâ mihi,

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

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References

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1. mailto:[email address]

Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:

 

Christmas (25 December 2021)

Summer Holidays (25 December to 15 January)

New Year's Day (1 January 2022)

Day after News Year's Day (2 January 2022)

 

If you'd like to calculate the due date for your request, you can use the
Ombudsman's online calculator here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

show quoted sections

References

Visible links
1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

Tēnā koe R

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 15 November 2021. ​You
asked for:

“... any documents you have regarding the Pfizer mRNA vaccines that
include information regarding the production of spike proteins in the body
post vaccination including, but not limited to, duration of production by
human cells (i.e. how long are they produced by the body), spike protein
production amounts (i.e. how many mg of protein will be produced? How many
individual proteins will be created?)”

On 2 December 2021, ​you were contacted by the Ministry ​to refine the
scope of your request as ​suspected in scope were a number of versions of
the same document. On December 2021, you refined your request to the first
and most recent version of this document.

Upon further analysis, it has become apparent that the documents the
Ministry had initially indicated ​were not in scope of your request. While
there is note of the spike protein in some of the older documents, none of
these documents contain information regarding the how much of the protein
is produced or for how long they are produced. The Ministry does not hold
any documents discussing these topics. ​As such your request is refused
under section 18(g)(i) 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.

​The Ministry apologises for the confusion regarding these documents ​and
any inconvenience this may have caused.

​However, please find below are some questions and answers you may find
helpful:

How does the mRNA particle get from the vaccine site into the cell. What
is the cross-membrane transport mechanism?

The vaccine is administered intramuscularly. Muscle tissue contains immune
cells that can internalise and process mRNA-encoded antigens. Once
injected into the muscle, the lipid-mRNA nanoparticle crosses the cell
membrane via a process called endocytosis, where it is transferred into
the cytoplasm of immune cells in particles called endosomes. The more
acidic environment within the endosome causes the lipid nanoparticle to
interact with the endosomal membrane, which leads to release of the mRNA
into the cytoplasm. More information can be found [1]here and [2]here.

Given that there is a bolus of vaccine, how does it remain in the muscle
and not travel to other sites?

The muscle tissue contains immune cells that can recognise the antigen. In
the case of the Pfizer vaccine, the spike protein is the antigen that is
produced in the body after vaccination, using the mRNA as instructions
(see question 4 below). Injecting the vaccine into muscle tissue keeps the
vaccine localised and it cannot travel other sites unless it is taken up
by immune cells. After the antigen is produced within the immune cells in
the muscle tissue, the cells transport the antigen to the lymph nodes,
where the immune response develops ([3]link). Many vaccines are injected
in the deltoid because it is close to lymph nodes located just under the
armpit. Animal studies have found that intramuscular vaccines mostly
remain near the site of injection and local lymph nodes ([4]here and
[5]here).

Once the artificial mRNA is taken up by the ribosome, what turns on
translation and what turns it off?

The ribosome is a complex molecule located in the cytoplasm that has the
ability to translate RNA sequences into amino acids, which leads to the
synthesis of a protein. Translations begins with the start codon (AUG),
this indicates where on the mRNA translation is to begin. The ribosome
reads the provided mRNA (that codes for the spike protein) and translates
this mRNA into a protein by adding each amino acid in the order that the
mRNA instructs. At the end of the mRNA sequence, there is a stop codon
(UAA, UAG, or UGA), which tells the ribosome that it has finished making
the protein. The mRNA in the Pfizer/BioNTech COVID-19 vaccine features an
AUG start codon and two consecutive UGA stop codons ([6]link). The
ribosome then detaches itself from the mRNA. More information can be found
[7]here.

How is the artificial mRNA dealt with after the end of translation?

Once the mRNA has been translated, it is rapidly degraded by a series of
enzymes located both intracellularly and extracellularly ([8]link). mRNA
is a naturally unstable molecule, and that is why the mRNA in the Pfizer
vaccine has a lipid outer layer for added stability and requires ultralow
temperature storage. Studies have indicated that mRNA transcripts are
usually degraded within 10-15 minutes ([9]here and [10]here) .

How does the translation product (artificial spike protein) get from the
ribosome to the appropriate location to be recognised by the acquired
immune system?

After the spike protein antigen is produced, it travels to the surface of
the immune cell and attaches to a receptor on the cell surface. The immune
cell then travels to the nearby lymph node and presents the attached
antigen to other adaptive immune cells, activating them and initiating an
acquired immune response. More information can be found [11]here.

Once in the cytoplasm what mechanism is in place to ensure the artificial
mRNA particle cannot cross the nuclear membrane?

While RNA is readily transported out of the nucleus (this is mediated by
several accessory proteins, e.g., nuclear export factor), it is not
transported into the nucleus. In addition, the nuclear membrane has
nuclear pore complexes (NPCs) present which impose limits on the size of
the particles that can freely enter. Some types of RNA-based viruses like
the influenza virus can be transported into the nucleus as they contain
proteins associated with their genome, called ribonucleoproteins, which
help transport their genomic RNA into the nucleus ([12]link). The mRNA
from the Pfizer-BioNTech COVID-19 vaccine does not have any of these
proteins associated with it, so it cannot enter the nucleus.

How do we know that the artificial mRNA particle is not reverse
transcribed to become part of the host genome. Specifically is there
safety testing research you can point me to that addresses this question?

The mRNA from the Pfizer-BioNTech COVID vaccine cannot enter the nucleus
of human cells to be able to interact with the person’s DNA. RNA is
readily transported out of the nucleus (this is mediated by several
accessory proteins e.g., nuclear export factor) but it is not transported
into the nucleus. In addition, the nuclear membrane has nuclear pore
complexes (NPCs) present which impose limits on the size of the particles
that can freely enter. Some types of viruses like the influenza virus are
transported into the nucleus – these viruses have proteins (called
ribonucleoproteins) associated with their genome that help transport their
genomic RNA into the nucleus ([13]link). The mRNA from the Pfizer-BioNTech
COVID vaccine does not have any of these proteins associated with it. Any
viruses that have reverse transcriptase (for example retroviruses) cannot
transcribe the mRNA from the Pfizer-BioNTech COVID vaccine into DNA
because reverse transcriptases are not capable of picking up any random
RNA and generating DNA from it ([14]link).

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: [15][email address] or by calling 0800
802 602.

Nāku noa, nā

OIA Services

Office of the Director-General

Ministry of Health

E: [16][email address]

L1 North, Yellow, 133 Molesworth St, Wellington

show quoted sections

References

Visible links
1. https://www.ema.europa.eu/en/documents/a...
2. https://www.nature.com/articles/s41578-0...
3. https://www.nature.com/articles/s41578-0...
4. https://www.sciencedirect.com/science/ar...
5. https://www.ncbi.nlm.nih.gov/pmc/article...
6. https://www.ncbi.nlm.nih.gov/pmc/article...
7. https://www.nature.com/scitable/topicpag...
8. https://www.ncbi.nlm.nih.gov/pmc/article...
9. https://www.ncbi.nlm.nih.gov/pmc/article...
10. https://www.ncbi.nlm.nih.gov/pmc/article...
11. https://www.ncbi.nlm.nih.gov/books/NBK26...
12. https://www.sciencedirect.com/science/ar...
13. https://journals.asm.org/doi/full/10.112...
14. https://www.nature.com/scitable/topicpag...
15. mailto:[email address]
16. mailto:[email address]

Kia ora,

 

Thank you for your follow up request for official information. The
Ministry's reference number for your request is: H202117915.  

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:

 

Christmas (25 December 2021)

Summer Holidays (25 December to 15 January)

New Year's Day (1 January 2022)

Day after News Year's Day (2 January 2022)

 

Your request has been logged and you can expect a reply no later than 8
February 2022 as required under the Official Information Act 1982.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

show quoted sections

Tēnā koe R,

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 21 December 2021 for
information regarding COVID-19 vaccinations. Each point of your request is
answered in turn.

 

1. Any interactions that occur between spike proteins and the people who
have been vaccinated with a COVID related vaccine.

 

Or, if that request is too large,

 

2. A list of document titles related to the above.

 

The Ministry does not any information regarding this topic. As such, this
part of your request is refused under section 18(g)(i) 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.

 

3. Any documentation regarding the duration that spike proteins remain in
the vaccinated.

 

Please note, the Ministry does not conduct medical research. You can find
information regarding the spike protein, including how long it lasts in
the body,
here: [1]www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html.

 

4. Any risk/benefit analysis for child vaccinations.

 

Clinical trial information can be found at the following
link: [2]https://clinicaltrials.gov/ct2/show/NCT0....

 

An evaluation of the results of this trial can be found at the following
link: [3]https://www.nejm.org/doi/full/10.1056/NE....

 

Further information can be found in the datasheet
here: [4]https://medsafe.govt.nz/profs/Datasheet/....

 

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: [5][email address] or by calling 0800
802 602.

 

Nāku noa, nā

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [6][email address]

 

 

show quoted sections

References

Visible links
1. http://www.cdc.gov/coronavirus/2019-ncov...
2. https://clinicaltrials.gov/ct2/show/NCT0...
3. https://www.nejm.org/doi/full/10.1056/NE...
4. https://medsafe.govt.nz/profs/Datasheet/...
5. mailto:[email address]
6. mailto:[email address]