Official Information request - Novavax and Valneva

Viv Laursen made this Official Information request to Ministry of Health

Ministry of Health did not have the information requested.

From: Viv Laursen

Dear Ministry of Health,

I understand that Novavax has been purchased by the government as is stated on the health.govt.nz website: "We’ve agreed with Novavax to purchase 10.72 million doses of a COVID-19 vaccine. This vaccine needs two doses. Enough for 5.36 million people. We’re not likely to receive this vaccine until later in 2021."

Question 1. When will this vaccine be availble to the New Zealand public for vaccination?

I note that the French vaccine Valneva is being trialled here in NZ (https://covid19.trackvaccines.org/countr...), with pre-purchase agreements with the UK government ordering 100 million doses for supply in 2021 and 2022 up to 190-million doses by 2025, and European countries along with Australia considering it/in talks with the company.

As VLA2001 is a whole virus, inactivated, adjuvanted vaccine and is the only candidate of this type currently in clinical trials in Europe, and here in NZ, this would be an excellent vaccine for NZ to purchase giving broad immunity to Covid-19 and it's variants.

Question 2. Will New Zealand be purchasing this vaccine once it has finished phase three clinical trials and been approved for use? If so when?

Question 3. If the government has decided not to publicly fund it, but it's still approved for use here, will consumers be able to purchase it through their GP's for vaccination?

Warm Regards,
Viv Laursen

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From: OIA Requests

Kia ora,
Thank you for your email. Your query has been passed on to the COVID-19
Vaccine and Immunisation Programme for a response.
You can expect a response from the team directly in due course.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

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This is an Official Information request made via the FYI website.

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Amy Whitehead left an annotation ()

Dear Sirs,
I also sent a similar request for this information and I would like to know whether or not the Valneva whole virus covid vaccine will be purchased if approved in the coming months. This, for many, will be a more viable and attractive option.
Kind Regards
Amy Whitehead

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Chris Wardle left an annotation ()

I have also asked this same question of ACT and NATIONAL - I am looking forward to the response also.

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Catharina Treeby left an annotation ()

Hello, as a so far unvaccinated person, I am waiting for Novac, as health worker i am now under huge pressure to have the mrna vaccine. I would like any information on the roll out, or even trails I could part in as it comes available. Thank you, Catharina.

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Brad Marsh left an annotation ()

I too will await a traditional vaccine, that is one without the mRNA technology. There are a number of possibilities and NZ has already purchased sufficient Novavax to inoculate the entire population. I will be first in line for Novavax or even better the Valneva product when available. I am sure many others who are falsely labelled anti-vaxxers are simply do not trust the safety of the mRNA vector which still is only under Emergency Use Authority. It also stems from well-founded distrust of big-pharma who have been caught lying plenty before this. They will do anything and tell us anything for profit and cannot be trusted. If you want many more NZers to accept a SARS-COV-2 vaccination then expedite the availability of Novavax.

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Niki Smith left an annotation ()

Yes, Minister Chris Hipkins, you have the power to FAST TRACK the approval of the Novavax vaccine for New Zealand. If you really "care about the people" of New Zealand and want us ALL vaccinated then you, cabinet and Medsafe must approve the Novavax Vaccine. What is your time frame for approval?

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victor left an annotation ()

The comments and readers under the misconception of 'traditional style ' of vaccine need to widen the intake of informative materials.

On top of that pay attention to the official data sets which describe unequivocally there is no need for vaccines of any technology given the recovery rates in Nz and global being 99.xx all the way through to the 70 year age group.

Without any treatment or injections at all.

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Christopher James left an annotation ()

I am not vaccinated. I am not against vaccination as a means to prevent illness or sickness and to provide protection. I have been vaccinated – as most of us – against tetanus, smallpox and so forth as required.
However, I am not intending to get vaccinated with the mRNA versions of vaccination which at the moment is the only choice in New Zealand. I am confident that other choices will be made available in the near future for New Zealanders to be vaccinated with, in particular, the more traditionally designed vaccines, some of them currently used overseas.
This is not the current view of the Ministries of Health and Education which might also be reflected in new legislation. Hence I will have to reluctantly stop teaching for now unless a way can be found by way of compromise for me to teach and still obey the Covid protocol.
I would prefer Valneva or Sinopharm/Sinovac if and when they become available.

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Grant Collingwood left an annotation ()

Note the following from Valneva 1 day ago. The Phase 3 results from 4000 UK trialists:
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October 18, 2021

VLA2001 successfully met both co-primary endpoints
Superior neutralizing antibody titer levels compared to active comparator vaccine, AstraZeneca’s AZD1222 (ChAdOx1-S)
Neutralizing antibody seroconversion rate above 95%

VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S, M and N proteins.

VLA2001 was well tolerated, demonstrating a statistically significant better tolerability profile compared to active comparator vaccine
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Valneva would love to sell vaccines to a country, and what a great way to catch all those hesitant about mRNA. An instant increase in Vaccination percentages, plus a great option for boosters when the mRNA wears off.

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Ruth Urban left an annotation ()

I’m pro vax and pro science, however I won’t have the Pfizer shot due to it causing too many deaths and adverse reactions. I would be willing to take Valneva, or perhaps Novavax, so why not give people a choice. If this campaign to get the whole population vaccinated is really for health reasons, then brand shouldn’t be an issue.

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Sally Stockdale left an annotation ()

I don’t understand the hesitancy on the part of the government to offer an alternative vaccine if they truly want everyone to be vaccinated.
For those unable to be inoculated with the Pfizer jab, or those who are hesitant to do so, they should be offered Valneva. It is a traditional vaccine, and the trials have shown it to effective with few side effects.

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Danni left an annotation ()

@Sally - Money. The paid a lot of money for a bunch of Pfizer jabs and they need to use them up. If they offer a second alternative now, they might go to waste. The 3rd booster shot idea was a good way to get rid of them and look like a hero. If they truly wanted people to be vaccinated they would be reviewing a 3rd option like Janssen in case Medsafe don't approve Novavax but of course they'll wait until the very last minute before figuring that out

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Carol Foxe left an annotation ()

I would like to have a choice and if Valneva was available, I would definitely consider it.

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Annemarie Van Der Plas left an annotation ()

We are a retired couple,fit and healthy,not vaccinated,due to hesitating to take Pfizer vaccine.
We would be far more interested in the Valneva vaccine,once approved and the NZ government,if serious about health and safety,should put in an order as this vaccine is also suitable as booster shot for already double vaccinated with Pfizer

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Shaz4 left an annotation ()

If the govt truly wants everyone vaccinated, then surely offering alternatives achieves this aim. I don't want to be bullied into having Pfizer, as I'm not comfortable with it. Novavax has been shown to be incredibly effective and Valneva VLA2001 is showing extremely promising results. I'm hoping Valneva VLA2001 will be approved here as soon as possible.

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GV left an annotation ()

You all may have already sent your concerns and appeal to the govt re. choice of safe, inactivated vaccine choices, but if not and for good measure, here are the PM's and Health Secretary's email addresses:

jacinda.ardern@parliament.govt.nz
Chris Hipkins - Georgia Roden | Health Private Secretary: Georgia.Roden@parliament.govt.nz

Polarized and blinkered media and a much-needed pivotal change from the pro- and anti-vax 'battle' which they've created, to a push for Choice too ... Emails and txts!

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Russ left an annotation ()

I was fortunate enough to be accepted into the Valneva trial. I've had both shots and extremely positive group and personal test results. Unfortunately the NZ government, and others, consider me unvaccinated. What the Valneva volunteers have done for science and the global Covid vaccine initiative should be considered pretty great and as the antibody results and overall test results are as good or better than what is currently being offered, perhaps this government should do something to recognise this. As others have said, the mRNA is not of interest to a % of the population and Valneva is based 100 year old technology that has been proven and still works. Oh the Valneva is a deactivated whole virus which has greater potential to handle variants and likely longer lasting.

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From: OIA Requests


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Kia ora Viv,

 

 

Thank you for your email.

 

Medsafe is New Zealand’s own medicines safety authority. They robustly
assess all vaccines to ensure they meet international standards and local
requirements for quality and safety. If you would like to check the
approval of any COVID-19 vaccines in New Zealand, you can do so on
Medsafe's website here:
[1]https://www.medsafe.govt.nz/COVID-19/sta...

 

Medsafe approval is one step in the process for accessing a COVID-19
vaccine. Once approved, Cabinet then considers advice and makes decisions
on when and for who a particular vaccine will be used as part of the
COVID-19 immunisation programme. If or when Cabinet approves a 'decision
for use', this would determine how the Novavax vaccine would be used in
New Zealand.

 

At present no decisions have been made regarding the remainder of your
queries, therefore the Ministry is unable to provide further
comment. However, please note that updates are regularly provided through
the following channels:

o The Ministry of Health website
o Medsafe website
o [2]Unite against COVID-19 website

 

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 calling 0800
802 602.     

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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This is an Official Information request made via the FYI website.

Please use this email address for all replies to this request:
[FYI request #16673 email]

Is [Ministry of Health request email] the wrong address for Official Information requests
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From: OIA Requests

OIA Requests would like to recall the message, "PLS CHECK - Response to your correspondence 8 September 2021".

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From: OIA Requests


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Kia ora Viv

 

 

Thank you for your email.

 

Medsafe is New Zealand’s own medicines safety authority. They robustly
assess all vaccines to ensure they meet international standards and local
requirements for quality and safety. If you would like to check the
approval of any COVID-19 vaccines in New Zealand, you can do so on
Medsafe's website here:
[1]https://www.medsafe.govt.nz/COVID-19/sta...

 

Medsafe approval is one step in the process for accessing a COVID-19
vaccine. Once approved, Cabinet then considers advice and makes decisions
on when and for who a particular vaccine will be used as part of the
COVID-19 immunisation programme. If or when Cabinet approves a 'decision
for use', this would determine how the Novavax vaccine would be used in
New Zealand.

 

At present no decisions have been made regarding the remainder of your
queries, therefore the Ministry is unable to provide further
comment. However, please note that updates are regularly provided through
the following channels:

o The Ministry of Health website
o Medsafe website
o [2]Unite against COVID-19 website

 

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 calling 0800
802 602.     

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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This is an Official Information request made via the FYI website.

Please use this email address for all replies to this request:
[9][FYI request #16673 email]

Is [10][Ministry of Health request email] the wrong address for Official Information
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Disclaimer: This message and any reply that you make will be published on
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If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
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Sally Stockdale left an annotation ()

@Russ - just unbelievable. I had hoped to be in that trial as well, but no luck. I hope Valneva will be recognised by other countries soon, and NZ will have to acknowledge the efficacy of that vaccine. At least you have the knowledge that you are vaccinated with good protection. I hope fairness will prevail so the 300 NZ people who volunteered and made a contribution to science are not penalised. Thanks for your efforts.

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victor left an annotation ()

Many comments from those seemingly unable to process the logic using official government data sources which prove there is no requirement for any vaccination as a response.

When viewed through marketing techniques the comments of those that are not informed sufficiently becomes clear.

NZ
0.122% have allegedly had C19 diagnosis (including unconfirmed probables)

0.00844% of 0.122% hospital or ICU

0.00056% of 0.122% allegedly died

Which pharmaceutical interventions are required for entire populations based on the NZ government statistics.

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J Hart left an annotation ()

I was also a participant in NZ in the NZ trial of the Valneva vaccine.

I requested recognition of my vaccination status two ways- through my GP (to have my status recognised)
- and by emailing the MOH

I received a “NO”

I then went on to receive the first Pfizer (to my detriment in health and subsequent reaction)

I will NOT get a FOURTH vaccine

I want and deserve recognition of vaccination

Jeni

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Milly left an annotation ()

Myself included, 6 of my immediate family members are being 'removed' from their positions (5 teachers across 3 sectors, and one community chaplain for the IHC). None of us are 'anti-vax' but we are critical thinkers and know how to research. We would all accept the Novavax and/ or Valneva, but will not accept the P%#!@%. Unlike most Kiwis, we know best evidence (e.g the recent study published in the Lancet) shows we are no more likely to pass on or contract the virus being unvaccinated. I would be very surprised, however, if these more safe and effective alternatives do came; the P%#!@% contract with NZ - which will never be fully disclosed even for an army of OIA requests - won't allow it.

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Andrew F left an annotation ()

And nothing of value was lost.

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SusieQ left an annotation ()

I, too, will not take the mRNA vaccine or the alternative that they are talking about with is either J & J or Astra Zenica. I have read too many articles regarding the safety of both of them, plus have dear friends who have had horrible reactions to them. A very highly respected doctor that I follow who is NOT an anti-vaxxer, wife had the J & J vaccine, sadly, she is still having reactions from it and she had the injection 6 months ago. I am definitely not an anti-vaxxer, but I am sure anti these. I would very gladly take either the Novavax or the Valneva, but unfortunately, it appears that the Novavax will not be coming in here even though a few months back, articles from the Ministry of Health said it would. This is so upsetting. I truly believe that "P" has control over what we can and cannot use, and it is infuriating.

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victor left an annotation ()

Why are people allowing themselves to be coerced into a position where they appeal for products which also contain nano particulates and ingredients equal in risk of that currently in use in NZ.

Ingredients which will then be hidden behind commercial sensitivity as being done with BNT162b2 Comirnaty.

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From: OIA Requests


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Tçnâ koe Viv

 

Thank you for your request under the Official Information Act 1982 (the
Act) on 8 September 2021 for information related to Novavax. You requested
specifically:

 

“Question 1. When will this vaccine be available to the New Zealand public
for vaccination?
Question 2. Will New Zealand be purchasing this vaccine once it has
finished phase three clinical trials and been approved for use? If so
when?
Question 3. If the government has decided not to publicly fund it, but
it's still approved for use here, will consumers be able to purchase it
through their GP's for vaccination?”

 

The process of assessing the Novavax for regulatory approval in New
Zealand has commenced, with an application for approval lodged with
Medsafe. The Ministry of Health (the Ministry) is unable to confirm if,
when and under which circumstances this vaccine will be available to the
public.

 

It is important to note that the Act allows people to ask for information.
It does not require the Ministry to create new information, compile
information it does not hold, or in the case of these parts of your
request, to comment on hypothetical statements. These parts of your
request are therefore refused under section 18(g) of the Act as the
information is not held by the Ministry and there are no grounds for
believing it is held by another agency subject to the Act.

 

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

  

Nâku noa, nâ

 

OIA Services Team

 

[2]Ministry of Health information releases

[3]Unite against COVID-19

 

 

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Carolyn Bennington Goss left an annotation ()

Novavax has been approved for emergency use in Indonesia and now the Phillipines!
Why is it taking so long for New Zealand to approve and offer it to the public as a more safe alternative?
If this government was all for getting everyone vaccinated as they claim, surely they would be prepared to offer us choices that we feel comfortable putting into our bodies.
I want to be vaccinated like everyone else but I as a 65 year old woman think I should have the right as a citizen of this country to have a choice, not be dictated to as though I am a child! There should be safer options for us, where are they?

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GV left an annotation ()

Email your concerns to Chris.Hipkins@parliament.govt.nz as they may not be read here.

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Sally Stockdale left an annotation ()

Those who participated in the Valneva NZ trial can get an exemption and get the passport. https://www.health.govt.nz/system/files/... details in the link.

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Shaun left an annotation ()

Are there any ways people like me could help request these alternative vaccines and put pressure on the government to provide them for people unsure about the MRNA vaccines? I'd love to know

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Amy Whitehead left an annotation ()

I have written to Chris Hipkins a few times now (as well as Bloomfield, and the PM), requesting Novavax and suggesting Valneva (Valneva won't roll out anywhere for a while yet - probably mid next year). But - Novavax is getting closer. Medsafe have received their application for use in NZ, and have requested further information/data from them. I'm not sure what that means for timing. I'm just hoping that Novavax might be here by January at the latest.

As for pressure, there was a petition called 'Get us Novavax vaccine' that closed yesterday. It received 6,026 signatures. Let's hope the govt take notice.

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SusieQ left an annotation ()

I sent an email to Chris Hopkins last week, all I got was a form letter saying that Novavax was waiting approval from Medsafe. I don't believe them, I read that Medsafe had already approved it. I don't think think our government is being honest about it at all. I seem to also recall hearing or reading that Ashley Bloomfield said they wouldn't be bringing it in here and that no country had used it. All this has me so upset, I refuse to use the two that they are using, they're not safe.

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Grant Collingwood left an annotation ()

Just found a petition to send this request to the NZ government here:

Petition of Tyler Bizzell: Make other COVID-19 vaccine options available urgently
https://www.parliament.nz/en/pb/petition...

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Grant Collingwood left an annotation ()

Want to help ?

Sign this petition asking govt for these vaccines to allow people to choose
https://www.parliament.nz/en/petitions/c...

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Shaun left an annotation ()

Thank you for the responses and updates everyone. Yes I remember signing the first petition for the novavax that just got sent. And thank you Grant, I just signed the petition you linked.

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Karen Law left an annotation ()

https://www.medsafe.govt.nz/COVID-19/sta...
Novavax has provided some data to Medsafe for the rolling assessment but still needs to provide further data as it becomes available. Timing for completing the assessment is dependent on when Medsafe receives all the data, the quality of the information provided, and the time taken by Novavax to respond to any requests for further information that may be required.

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GV left an annotation ()

Thanks for updates everyone.

Signed the latest petition and forwarded to many, thanks Grant. Just checked back and there are 132 signatures so far. Here's hoping for many more.

I've written, several times, to Bloomfield et al. At some point they have to sit up, take notice, and provide reliable responses. Although I have to say i simply no longer trust this Government. Sad.

Am thinking of emailing Novovax, urging them to provide swift and extensive - as far as they can at any given time - info to Medsafe.

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Carolyn Bennington Goss left an annotation ()

Update on application for approval to Medsafe for Novavax on Novavax website press releases.
Press release on 03.11.21 states that “all modules required for regulatory review of Novavax Vaccine including CMC data are now complete for Medsafe”
I gather that the Medsafe website has not updated information on the progress of Novavax approval.
Would be good if the public were listened too instead of this awful discrimination and lack of choice.

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Cathy Macleod left an annotation ()

I learned abut the valneva by accident and volunteered for the trial however enough volunteers were available at that stage. I too have been advised against the mRNA and have growing concern re it's safety, as the reports of adverse reactions unfold. As a teacher with a prochoice stance re bodily autonomy, saw that the valneva could provide a solution for many, so wrote to the minister (twice) requesting information re it's availability, with no response. That other options that were approved either here or overseas remain unavailable with additional information to support an informed choice withheld, alongside either silence and/or stock standard responses coming from the ministry, is unacceptable in what is purported to be a democratic country.

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Karen Law left an annotation ()

I just thought I'd share this info which is directly from novavax website for those who might might be having difficulty finding it.
"Today's submission marks Novavax' continued progress in bringing the first protein-based COVID-19 vaccine based on phase 3 data to the global community," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain laser-focused on delivering our vaccine, which is built on a proven, well-understood vaccine platform, and thank the Government of New Zealand for their ongoing partnership and confidence in our COVID-19 vaccine program."

Novavax has now completed the submission to Medsafe of all modules required for the regulatory evaluation of NVX-CoV2373, a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant."

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Karen Law left an annotation ()

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Carol Foxe left an annotation ()

I am writing to support the annotation posted by Cathy Macleod. I also volunteered for the Valneva trial but numbers had closed off. I have ethical, safety and health concerns about the vaccines available in New Zealand. Valneva could provide a real choice for me as I am a mandated employee.
I support Cathy's concerns about the lack of choice in this matter and lack of meaningful responses from the MOH. With the introduction of the 'pass' system, our government is supporting and encouraging discrimination against a group of people for health reasons which I find totally unacceptable and fills me with dismay and sadness.

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Amy Whitehead left an annotation ()

You are not alone. I have written repeatedly to the MOH asking for alternatives to the current vaccines. I am also in a mandated sector, and I know too many people, mainly in the US and UK (two family members included) who are reacting badly to the Pfizer jab. The 'safe and effective' narrative should really be rested now - we know that it is not safe for a lot of people, and we know that it is a porous vaccine. The government are also aware that there will be vaccine casualties.

Valneva will be rolling out in Europe in the new year. I'm not sure when. We must continue to put pressure on the government to purchase this vaccine when it comes available and to give us choice (choice in which vaccine to take; and choice to NOT take a vaccine if we choose for the sake of our employment). Novavax would be my second choice, and it 'might' be in NZ in the coming months (depending on contracts and different politics to which we are not privy, which is unfortunate seeing as it is our tax payer dollars that are funding these contracts/public health responses).

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Christopher James left an annotation ()

I too am writing in support of the annotation posted by Cathy Macleod and Carole Foxe. My wife and I also volunteered for the Valneva trial but numbers had closed off. We too have ethical, safety and health concerns about the vaccines available in New Zealand and Valneva could well provide a real choice for us as I am in a mandated sector being itinerant music teacher.
I support Cathy's and Carole's concerns about the lack of choice in this matter and lack of meaningful responses from the MOH.
I too find that our government is supporting and encouraging discrimination against a group of people for health reasons which I find totally unacceptable.

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H Abadeeah left an annotation ()

So far I have not been vaccinated against Covid-19, although I had a flu injection earlier this year and have had all my vaccinations in the past.
I do not want an mRNA vaccine (Pfizer/Moderna) nor a viral vector (AstraZeneca/Janssen) vaccine, but I would take a Novavax or Valneva vaccine if it was available.
People should not be coerced into taking a vaccine they are unhappy with and then punished if they remain unvaccinated because of a lack of choice.
Novavax should be made available as soon as possible.
H Abadeeah

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Carolyn Bennington Goss left an annotation ()

I also have very strong reservations about the vaccines available here. Personally know of people with severe reactions to them and I have allergic reactions to four different medications so am not about to play Russian roulette with these vaccines.
Novavax is deemed to be the safer option and I’d like to know why it is taking Medsafe so long to approve? World Health and EMA have approved it this week and Australia are talking of receiving 50 million doses in January so clearly they expect the TGA to approve it in the coming days. So why isn’t NZ government looking out for the rest of us. No, we are being punished for not conforming. It’s frustrating the hell out of me. Where is our freedom of choice as to what we put into our bodies. To me, one death because of a vaccine is one death too many. These things are supposed to help protect us, not kill us.

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