Medsafe Covid Vaccination Benefits and Risks Evaluation Results
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From: Peter
Dear Ministry of Health,
With reference to the information posted on the Medsafe website at https://www.medsafe.govt.nz/Consumers/Sa...
It is stated that Medsafe evaluates the benefits and risks of medicines to ensure the safety profile of the medicine is acceptable based on clinical studies performed using such medicine.
Please could you provide me with:
The clinical studies that Medsafe used to evaluate the safety and efficacy of the Pfizer Covid Vaccine.
This must include Medsafe’s own analysis of the results of these clinical trials against the factors listed on their website.
Namely the benefits:
- Efficacy demonstrated in the target (who was the target group?) population (ie, those who will and who are using the vaccine)
- That the vaccine is significantly better than a placebo (What placebo was used? And who is the control group?).
- Alternative treatments the vaccine was compared to and the documentation on how those comparisons were evaluated for efficacy and safety.
- The number of people anticipated or diagnosed to have Covid that this vaccine is meant to prevent.
- The natural history of the covid virus (there is reason to believe this is not a “novel” virus based of patents that have been registered several years before)
- The level of mortality of the virus.
Risks:
- The proportion of people taking the vaccine that have had adverse reactions (both locally and abroad - it is assumed that consideration was given to all data other than just national).
- The number of these adverse reactions that were considered to be serious (both locally and abroad).
- The number of people who stopped taking the vaccine because of an adverse reaction (both locally and abroad).
- How many of these adverse reactions were reversible, treatable or avoidable.
Considering that this vaccine is not FDA approved and experimental. And that mRNA technology has been plagued with problems in the past it would be reasonable to assume that Medsafe has done their due diligence with regards to evaluating this drug.
Can you also provide:
- A full list of the ingredients contained in the Pfizer vaccination, together with documented, independent, scientific evidence of the efficacy or otherwise of each ingredient.
- Documentation of any independent microscopic examination Medsafe has done to verify that there are no inorganic or toxic components in the vaccine that can pose a health risk.
Thank you in advance for taking the time to provide me with this information.
Yours faithfully,
Peter Mark van Wyk
From: OIA Requests
Kia ora Peter,
Thank you for your request for official information received on 15 October
2021 for:
"The clinical studies that Medsafe used to evaluate the safety and
efficacy of the Pfizer Covid Vaccine.
This must include Medsafe’s own analysis of the results of these clinical
trials against the factors listed on their website.
Namely the benefits:
- Efficacy demonstrated in the target (who was the target group?)
population (ie, those who will and who are using the vaccine)
- That the vaccine is significantly better than a placebo (What placebo
was used? And who is the control group?).
- Alternative treatments the vaccine was compared to and the documentation
on how those comparisons were evaluated for efficacy and safety.
- The number of people anticipated or diagnosed to have Covid that this
vaccine is meant to prevent.
- The natural history of the covid virus (there is reason to believe this
is not a “novel” virus based of patents that have been registered several
years before)
- The level of mortality of the virus.
Risks:
- The proportion of people taking the vaccine that have had adverse
reactions (both locally and abroad - it is assumed that consideration was
given to all data other than just national).
- The number of these adverse reactions that were considered to be serious
(both locally and abroad).
- The number of people who stopped taking the vaccine because of an
adverse reaction (both locally and abroad).
- How many of these adverse reactions were reversible, treatable or
avoidable.
Considering that this vaccine is not FDA approved and experimental. And
that mRNA technology has been plagued with problems in the past it would
be reasonable to assume that Medsafe has done their due diligence with
regards to evaluating this drug.
Can you also provide:
- A full list of the ingredients contained in the Pfizer vaccination,
together with documented, independent, scientific evidence of the efficacy
or otherwise of each ingredient.
- Documentation of any independent microscopic examination Medsafe has
done to verify that there are no inorganic or toxic components in the
vaccine that can pose a health risk.”
The Ministry's reference number for your request is: H202114508.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 15 November 2021, being
20 working days after the day your request was received.
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.
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]
From: OIA Requests
Kia ora Peter,
Thank you for your request received by the Ministry of Health (the
Ministry) on 15 October 2021 for:
“The clinical studies that Medsafe used to evaluate the safety and
efficacy of the Pfizer Covid Vaccine.
This must include Medsafe’s own analysis of the results of these clinical
trials against the factors listed on their website.
Namely the benefits:
- Efficacy demonstrated in the target (who was the target group?)
population (ie, those who will and who are using the vaccine)
- That the vaccine is significantly better than a placebo (What placebo
was used? And who is the control group?).
- Alternative treatments the vaccine was compared to and the documentation
on how those comparisons were evaluated for efficacy and safety.
- The number of people anticipated or diagnosed to have Covid that this
vaccine is meant to prevent.
- The natural history of the covid virus (there is reason to believe this
is not a “novel” virus based of patents that have been registered several
years before)
- The level of mortality of the virus.
Risks:
- The proportion of people taking the vaccine that have had adverse
reactions (both locally and abroad - it is assumed that consideration was
given to all data other than just national).
- The number of these adverse reactions that were considered to be serious
(both locally and abroad).
- The number of people who stopped taking the vaccine because of an
adverse reaction (both locally and abroad).
- How many of these adverse reactions were reversible, treatable or
avoidable.
Considering that this vaccine is not FDA approved and experimental. And
that mRNA technology has been plagued with problems in the past it would
be reasonable to assume that Medsafe has done their due diligence with
regards to evaluating this drug.
Can you also provide:
- A full list of the ingredients contained in the Pfizer vaccination,
together with documented, independent, scientific evidence of the efficacy
or otherwise of each ingredient.
- Documentation of any independent microscopic examination Medsafe has
done to verify that there are no inorganic or toxic components in the
vaccine that can pose a health risk.”
Clinical studies of the safety of the Pfizer vaccine can be found on the
New England Journal of Medicine (NEJM) at:
[1]www.nejm.org/doi/full/10.1056/nejmoa2034577
The Pfizer COVID-19 Comirnaty vaccine is not experimental. Medsafe has
granted Pfizer New Zealand Ltd provisional consent under section 23 of the
Medicines Act 1981. The Gazette notice authorising the sale, supply and
use of the vaccine is available
at: [2]www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette-Jun-2021.pdf
Information on all ingredients in the Pfizer vaccine can be found in the
datasheet at:
[3]https://www.medsafe.govt.nz/profs/Datash.... The
qualitative formulation is published in the Datasheet, and
on Medsafe’s website, and is a complete reflection of the vaccine
ingredients. The quantitative formulation is submitted to Medsafe and
reviewed as part of the evaluation process. The quantitative formulation
is submitted to Medsafe and reviewed as part of the evaluation process.
The clinical evaluation of the Pfizer vaccine is included in this
proactively released OIA response:
[4]https://www.health.govt.nz/system/files/...
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.
Ngâ mihi
Jan Torres
Manager (Acting) l OIA Services l Office of the Director-General l Manatû
Hauora Ministry of Health
[6]www.health.govt.nz
[7]Ministry of Health information releases
[8]Unite against COVID-19
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References
Visible links
1. http://www.nejm.org/doi/full/10.1056/nej...
2. http://www.medsafe.govt.nz/COVID-19/Comi...
3. https://www.medsafe.govt.nz/profs/Datash...
4. https://www.health.govt.nz/system/files/...
5. mailto:[email address]
6. http://www.health.govt.nz/
7. https://www.health.govt.nz/about-ministr...
8. https://covid19.govt.nz/
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