Trust the science, right?

Kiwis were repeatedly told that the vaccine stays in the arm and was quickly broken down.  The vaccine stimulated the immune system then went away.  As demonstrated in the video, this message has been repeated by multiple people advising New Zealanders to get the vaccine.  There must be some SCIENCE behind it surely. There’s certainly plenty that would say these statements are all rubbish, and it stands unrefuted until the government fronts with some science at least.

Medsafe must have access to the studies that have been done to demonstrate where the vaccine goes,  as well as when and how it is broken down.

One of our members was curious about the science and contacted Medsafe who were assessing the Pfizer data.

The following is the email chain trying to get to the science that showed the vaccine stayed in the arm and was quickly broken down.

The study or understanding of what the body does to a drug is called pharmacokinetics.  It covers the absorption, distribution, metabolism and excretion of a medication.

23 Sept 2021  Doctor

Hello,

Please can you point me to the studies that show how the mRNA in the Pfizer Comirnaty vaccine is metabolised or broken down?

Please can you also provide the studies that show what happens to the vaccine-induced spike protein in the human body once the mRNA has done its job?  I would like to know where it goes and how long it sticks around for.

The Comirnaty data sheet does not provide information for the pharmacokinetic properties of the vaccine.

Thanks very much.

Regards,

9 Oct 2021 Medsafe

Dear 

Information on how spike proteins work can be found here – https://www.medsafe.govt.nz/COVID-19/mRNA-vaccines.asp

Kind regards,

9 Oct 2021 Doctor

Thank you for getting back to me.  

I would like to be directed to the studies that Medsafe has used to prove what happens to the mRNA once it is in the human body. 

The information on the page you have directed me to tells me that “The mRNA is broken down shortly after vaccination. Animal studies showed that the mRNA in the Comirnaty vaccine is broken down within a couple of weeks.”  Can you please point me to the studies that are mentioned.  Has Medsafe used any studies in humans showing what happens to the mRNA?

I would also like to be directed to the studies that show what happens to the spike protein.  Once the body has used the mRNA to make the spike protein, where does the spike protein go, how long does it stay for, how is it excreted?

Thanks very much.

Regards,

9 Oct 2021 Medsafe

Dear 

Details about the main study can be found here – https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial

You can also see all the trials that Pfizer have done here – 

WHO Vaccine Tracker – https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines – if you download this and scroll down to Pfizer in the pre and post market tabs you can see a link to all the clinical trials which have been done and you can click on the link to look at the information on the register. 

Please note that none of these trials were run in New Zealand.

I hope this is of help.

Kind regards,

9 Oct 2021 Doctor

Hello 

Thanks for getting back to me.  When I look through the document at the first link you provide it says under Section 8.5. Pharmacokinetics: Pharmacokinetic parameters are not evaluated in this study.  This suggests they have not looked at the things I am interested in.  I could not find anything in this document that tells me what happens to the injected mRNA and the subsequently manufactured spike protein.

The second link takes me to a webpage where I can download a Vaccine Tracker spreadsheet.  Under the Clinical Tab on ID10 there appears to be links to numerous studies by PfizerBioNTech.  Rather than having to open them all up and look through them, can you please provide the direct link to the studies that Medsafe has used that show the Pharmacokinetic Properties of the vaccine. i.e. the link(s) to the specific journal articles where someone has studied what happens to both the mRNA and the spike protein (in humans) following injection of the vaccine.

Thank you.

Regards,

11 Oct 2021 Medsafe

Dear 

This is the main study – https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial

Kind regards,

11 Oct 2021 Doctor

Hello 

You have already referred me to this document and it says

8.5. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study.  

This means that they have not studied what happens to the mRNA and then the resultant spike protein in this study.

The information at https://www.medsafe.govt.nz/COVID-19/mRNA-vaccines.asp said: 

Animal studies showed that the mRNA in the Comirnaty vaccine is broken down within a couple of weeks.

Can you send me or direct me to these animal studies that are mentioned please?

Does Medsafe not have any studies (published journal articles) that relate to what happens to the mRNA that is injected into the human body and the spike protein that is then produced in the human body?

Regards,

11 Oct 2021 Medsafe

Dear 

The animal studies can be found here – https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1

The EPA report contains details of the Pharmacokinetics – https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

I hope this answers your queries.

Kind regards,

27 Oct 2021 Doctor 

Hello 

The first document you have linked to https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1 is a study in mice and macaque monkeys to look at the immune responses generated to the vaccine.  It does not detail what happens to the mRNA or the lipid nanoparticles once they have been injected, nor what happens to the spike protein apart from the fact that it stimulates an immune response in the animals.

The second document at https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf is not a published scientific study.  It is an assessment report by the European Medicines Agency.  It says in section: 

 2.3.2. of Non-Clinical Aspects – Pharmacokinetics  No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.   They have looked at the biodistribution of the lipid nanoparticles in rats and have looked at the biodistribution of a different mRNA encased in lipid nanoparticles in mice, but not the whole vaccine, so there is no information about where the vaccine mRNA goes or where the spike protein goes.  There is no information about how long the mRNA causes spike protein to be produced for. 

 2.4.2. of Clinical Aspects – Pharmacokinetics Not applicable. This means there is no information about the pharmacokinetics i.e. where the vaccine (mRNA and lipid nanoparticles) goes, how it is metabolised and excreted.

Are there, or are there not, any studies in humans showing what happens to the mRNA and lipid nanoparticles once they have been injected, or studies showing what happens to the subsequently manufactured spike protein?

Thank you.

Regards,

No further answer from Medsafe was forthcoming.

Should we trust Medsafe if they can not answer the most basic of questions?