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Pfizer vaccine for children, and status for vaccine trial participants

Amy Whitehead made this Official Information request to Ministry of Health

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From: Amy Whitehead

Dear Ministry of Health,
I have two queries. The first relates to the decision to vaccinate children between the ages of 12 and 15; and the second relates to the status of covid vaccine trial participants in New Zealand, and the potential for antibody testing as proof of Covid immunity.

I. Recently, a press release was made available through the GOV.UK website from the Joint Committee on Vaccination and Immunisation (JCVI) in the UK. As you will know, this body advises the government. It states:

"The assessment by the Joint Committee on Vaccination and Immunisation (JCVI) is that the health benefits from vaccination are marginally greater than the potential known harms. However, the margin of benefit is considered too small to support universal vaccination of healthy 12 to 15 year olds at this time."

This advice was given for 'healthy' children. Children with underlying conditions (there is a list - see in link below), it advises, should be vaccinated against Covid-19.

Further:

"There is evidence of an association between mRNA COVID-19 vaccines and myocarditis. This is an extremely rare adverse event. The medium- to long-term effects are unknown and long-term follow-up is being conducted.

Given the very low risk of serious COVID-19 disease in otherwise healthy 12 to 15 year olds, considerations on the potential harms and benefits of vaccination are very finely balanced and a precautionary approach was agreed."

So my first query, in relation to this, is why is this NZ government not also taking a precautionary approach to children under 15 years old, taking experience from a country that has had a great deal of real world experience (in addition to modelling) in dealing with Covid-19? Further, the UK is not recommending that children between the ages of 5-11 take the vaccine. It concerns me that this is being entertained in NZ when very little is known about the long term effects of Pfizer vaccine in children.

Further, has the government considered not vaccinating younger people (unless there are identifiable underlying conditions/vulnerability), and sending those vaccines instead to poorer countries so that their older populations can get vaccinated?

Here is the direct link to JCVI information:
https://www.gov.uk/government/news/jcvi-...

II. Many people have registered to take part in Cohorts I and II of the Valneva vaccine trial here in NZ. Cohort I is currently progressing for those over 56. Cohort II will have a wider age span, and this vaccine is developed specifically using a weakened version of the Delta variant (it's a whole vaccine). There are no placebos in this trial, and so far, those taking part in the trial in Europe are developing antibodies which may, again, be 'variant proof', or provide broader protection.

This vaccine is not, however, regulated (yet) or purchased (that I know of) by NZ. I am sure that ministers are wrestling with the details of how Covid passes or vaccine passports will work; but will there be a way to test and 'prove' that antibodies have been developed for those who are either in trials, or those who have had the disease? And will this be seen as legitimate proof of Covid 'immunity'?

If the point is that people are less likely to get the disease or pass it on, then antibody numbers should determine safety (not whether or not someone has take the Pfizer shot specifically - the efficacy of which will vary among individuals).

Will the government recognize antibodies, and other vaccines in addition to Pfizer?

It is my hope - along with many others - that the NZ government purchases a whole virus vaccine such as the more traditionally developed Valneva option. The uptake of such a shot would more than likely be well received amongst your Pfizer-hesitant.

Yours faithfully,
A. R. Whitehead

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From: OIA Requests


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Kia ora Amy,
Thank you for your email. 
While the Act allows New Zealanders to ask for information from Ministers
and government agencies, there is no requirement for agencies to create
new information, compile information they do not hold or provide or prove
an opinion. Many of your questions fall into this category. The Act does
not support requests where an opinion, comment, argument, or hypothetical
statement is put to the Ministry for response. Therefore, your remaining
questions are refused under section 18(g) of the Act on the grounds that
the information sought is not held by the Ministry. However, the Ministry
can provide some general information to assist. 

Information regarding how the Pfizer vaccine was developed and how its use
and effectiveness are being continually monitored,
here: [1]https://www.health.govt.nz/our-work/dise....

Information about Pfizer’s clinical trials with young people is available
here: [2]https://pubmed.ncbi.nlm.nih.gov/33795232/.

Information about the vaccine evaluation and approval process can be found
here: [3]https://www.medsafe.govt.nz/COVID-19/sta....

While other COVID-19 vaccines have been approved by Medsafe, Cabinet have
not yet made a 'decision to use' any other vaccines. Until this decision
is made, only the Pfizer/BioNTech vaccine is available in New Zealand.

At this stage Valneva is not part of New Zealand’s COVID-19 vaccine
portfolio. While the Ministry continuously reviews emerging scientific
evidence, including new vaccines and variants of concern, we are unable to
advise whether Valneva will be incorporated into our vaccine portfolio in
the future.

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

 

Ngâ mihi 

 
Nick Allan 

Manager, OIA Services 

[5]Ministry of Health information releases 

[6]Unite against COVID-19 

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References

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1. https://www.health.govt.nz/our-work/dise...
2. https://pubmed.ncbi.nlm.nih.gov/33795232/
3. https://www.medsafe.govt.nz/COVID-19/sta....
4. mailto:[email address]
5. https://www.health.govt.nz/about-ministr...
6. https://covid19.govt.nz/
7. http://scanmail.trustwave.com/?c=15517&a...
8. https://scanmail.trustwave.com/?c=15517&...
9. https://scanmail.trustwave.com/?c=15517&...
10. https://scanmail.trustwave.com/?c=15517&...

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From: OIA Requests

Kia ora,

Thank you for your request for official information. The Ministry's reference number for your request is: H202114771.

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: 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: [email address]

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Chuck Schooner left an annotation ()

Hi Amy,
There are all sorts of issues with these vaccines in children. Expect there to be an announcement that children who contract Covid-19 the virus will start developing a condition called multi-system inflammatory syndrome which has only become evident in children since mass vaccination. They will try pin this on virus rather than vaccine. Expect this to suddenly pop up in briefings saying a new condition in children from virus. It is vaccine not virus. Date this, expect there is a directive/correspondence from WHO already to MOH/people in charge.

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Kia ora Amy,

 

Thank you for your request on 4 October 2021 for the following:

 

“why is this NZ government not also taking a precautionary approach to
children under 15 years old, taking experience from a country that has had
a great deal of real world experience (in addition to modelling) in
dealing with Covid-19? Further, the UK is not recommending that children
between the ages of 5-11 take the vaccine. It concerns me that this is
being entertained in NZ when very little is known about the long term
effects of Pfizer vaccine in children.

 

has the government considered not vaccinating younger people (unless there
are identifiable underlying conditions/vulnerability), and sending those
vaccines instead to poorer countries so that their older populations can
get vaccinated?

 

Will the government recognize antibodies, and other vaccines in addition
to Pfizer?”

 

Unprecedented levels of global collaboration amongst scientists and
governments in vaccine development have improved the speed of the Pfizer
vaccine’s development and the launch of clinical trials around the world.
You can find out more about how the Pfizer vaccine was developed and how
its use and effectiveness are being continually monitored,
here: [1]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-clinical-trials-and-testing.

 

Medsafe assesses medicine and vaccine applications against internationally
established criteria. The stringent requirements vaccines must meet in
order to be approved remain in place under emergency circumstances, such
as the COVID-19 pandemic. Medsafe has found that the benefits of
vaccination with the Pfizer vaccine continue to greatly outweigh the risk
of both COVID-19 infection and vaccine side effects. More information
about the vaccine evaluation and approval process can be found
here: [2]www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp.

 

The COVID-19 Vaccine Technical Advisory Group (CV TAG) considered data
available on myocarditis coming from overseas reporting of this as a
potential safety signal following mRNA-based COVID-19 vaccination, and as
a separate matter on the risks and benefits of vaccinating 12-15 year olds
at several meetings, over a similar time period, before advising that
vaccinating 12-15 year olds was an appropriate use of COVID-19
vaccination, aligning with our message of protecting the individual, their
whânau, and our community in Aotearoa New Zealand. The advice from other
countries on these topics that was available at the time was considered by
CV TAG during the development of CV TAG’s advice. 

 

While Medsafe approved, and the Government has authorised, the vaccination
of young people aged 12 years and over, Medsafe is still considering an
application from Pfizer New Zealand Ltd for the vaccination of children
aged 5 and over. While the United States Food and Drug Administration
(FDA) has approved the use of the Pfizer Comirnaty vaccine for 5-11 year
olds on 29 October 2021, Medsafe will make its own recommendations
independently.

 

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: [3][email address] or by phone on 0800
802 602.

 

Ngâ mihi 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [4][email address]

 

 

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References

Visible links
1. http://www.health.govt.nz/our-work/disea...
2. http://www.medsafe.govt.nz/COVID-19/vacc...
3. mailto:[email address]
4. mailto:[email address]

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