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Drug regulators and governments must demonstrate there is no illegal human experiment underway by using untested technology in Covid-19 vaccines. Governments must prove we still live in a democracy.

by Stephanie Seneff
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covid-19

Guest Post By MUDr. Pavel Vašek, DiS.

About the author


Pavel Vašek, physician, public health specialist, and active researcher in the field of tumor immunology. Co-author of an article in the peer-reviewed journal Oncoimmunology — the same journal Nobel Prize winner James P. Allison published in as well (1). He authored the first proposition of Covid-19 therapy guidelines suitable for use in the Czech Republic just three months after the onset of the Covid-19 pandemic, in March 2020. The same month he co-authored with Pavel Smékal, captain in reserve, the Analysis of Protection of the Civilian Population against Covid-19 in the Czech Republic (2). Author of a number of analyses in connection with Covid-19, e.g. analysis of health risks and legal problems in the use of respirators and face masks in the Czech Republic (possible risk of oncogenesis included), analysis of mismatched Covid-19 statistics in the Czech Republic and others (2).

1. Introduction:

Approximately 6.5 million out of 10 million people have already been vaccinated against Covid-19 just in the Czech Republic alone. A new decree was unsuccessfully attempted to make Covid-19 vaccination mandatory for selected professions and people over 60 years of age in the Czech Republic.


Multiple laboratory, animal and human studies have pointed out possible serious risk of Covid-19 vaccination. Those risks include impairment of fertility (1,2) and a worsening course of Covid-19 infection with mutated strains of Covid-19 (3,4).  Impaired immunity after vaccination has also been suggested (5,6,7). This issue was also stressed in a warning issued by the European Medicines Agency (EMA) in January 2022 (8).

Different harmful pathological effects of antibodies generated against the same part of the virus as used in vaccination were clearly demonstrated in mice. Harmful effects of those antibodies were elevated by other antibodies that are formed during natural Covid-19 disease but not after vaccination (9).


Francis Boyle, professor of law in the University of Illinois, author of the US. Bioterrorism Act, and elite medical and international law expert, openly expresses the concern that Covid-19 vaccination is an illegal human experiment violating the Nuremberg Code (10).

Dr. Robert Malone´s Twitter account was banned after he used this platform to warn parents

against possible severe damage to children due to Covid-19 vaccination. Those risks included irreversibly damage of nervous, cardiovascular, and reproductive systems, as well as a number of other risks (11). Dr. Robert Malone was a key figure in the development of mRNA vaccine technology. So he is perfectly suited to evaluate risks of the technology he had helped to develop (12).

The use of Moderna’s mRNA vaccine has been partially banned in Finland, Sweden (13), Iceland (14) and France (15), as well as AstraZeneca’s vector vaccine in Austria, Denmark, Norway and Iceland (16).

Some of the above-mentioned adverse effects are caused by the presence of the active substance produced by the body in response to the Covid-19 vaccines, the so-called spike protein, but others could be caused by the technology those vaccines are based on.


It is of note that vaccine safety is based not only on the safety of the active substance it utilizes but also on the safety of the technology those vaccines are based on.


We should ask whether the technology that Covid-19 vaccines are based on is safe or not. Simply stated, we should ask whether or not people were used instead as guinea pigs.

How could it be that the government would conduct illegal experiments on human beings?

It may happen that there is a therapy that was assessed and authorized inappropriately. There are reasonable concerns that this misjudgment occurred during the Covid-19 vaccine approval process. I will try to explain why Covid-19 vaccines should have been assessed as gene therapy but were inappropriately assessed and approved as conventional vaccines. I will also try to explain why it matters.


2. Why do you believe that Covid-19 vaccination is gene therapy?

Put simply:
24-26.10.2021, Stefan Oerlich, head of Bayer’s pharmaceutical division, conference, Berlin.  Mentions mRNA vaccines as an example of gene therapy (1)

9.11.2018, Moderna, information for the US Securities and Exchange Commission. The company states that the use of mRNA is considered to be gene therapy according to the Food and Drug administration (FDA). Vaccination against infectious diseases utilizing mRNA technology is mentioned as an example of gene therapy that is under development at the Moderna company (2).


22.12.2020, World Health Organization (WHO), Report of the Strategic Advisory Working Group of Experts on Covid-19 vaccination. This document mentions that lipid nanoparticles enable transfection of cells in connection with the Pfizer vaccine (3). Transfection is the term used for transfer of genes into the interior of cells during the process of gene therapy. Pfizer uses this term to describe gene therapy processes on its website up until now (4).


Dr. Harry Al-Wassiti, Monash University (researcher at Monash University). Monash is one of the most prominent universities in Australia. It is ranked among the top 100 in the world. On September 11, 2019, Dr. Al-Wassiti used vaccination against viral infections based on mRNA technology and artificially assembled viruses (vector vaccines) as examples of gene therapy (5).


2012, Gamaley Institute, Russian Federation, patent of flu vector vaccine. This patent application refers to the vector vaccine – genetically modified virus – as gene therapy (6).  The AstraZeneca vaccine is of the same type. Therefore, the AstraZeneca vaccine is also a vector vaccine.

2006, FDA (US Food and Drug Administration). The FDA defines gene therapy as a therapy that achieves its effects by introducing genetic material into a targeted cell by means of nucleic acids, viruses or genetically modified micro-organisms (7).

What’s the problem?

The problem is that there is a substantial difference between “classical” vaccines and gene therapy. Let´s imagine a city where none of its inhabitants are able to leave their apartments. Transportation of anything in this city is provided by self-driving cars. To make transport smooth, you need small cars to transport small things and big cars to transport big things. You need cars of different brands, since some manufacturers make cars that can travel to a greater distance, some are more durable, etc. You end up with a varied mix of cars of different brands and sizes. All the cars use the same program to navigate and function regardless of obvious differences in sizes and brand names. We experience the same thing when using cell phones. There are very different cell phones to be used but almost all the cell phones utilize the same basic program to be operational no matter size, shape or brand name.

Now let´s go back to our car city with all the different self-driving cars in it. The most important question is:  how can it be done that all the cars are operated by just one program?

The solution is quite simple. All you need to make it work is to have a robust basic program with all functionalities for all cars written in it. Of course, you cannot allow all the functions to be active in all the cars.

So, since there is no way to apply all functions for all the cars, you have to block certain parts of the program for certain cars, depending on the car brand, size and other parameters.

Now let´s apply the above-mentioned metaphor to find out the difference between classical and gene therapy. Classical therapy is based on the fact that there are differences to be found in the hardware not software of the cars. All your work is about broken parts – hardware. You have to find out specific types of car with specific broken parts in them. Then you make the repair. The more specific is your knowledge about type of car and broken part to be repaired, the more effective the therapy and the less there are adverse effects. You never mess with the program.

Gene therapy, on the other hand, fixes the car by changing the car´s program and ignores the hardware of the car. The idea is that the car is capable to self-repair if the program is changed in an appropriate way. Gene therapy changes the car´s program so that the car can make its own spare parts to repair itself.

OK, but vaccination is not anything like blood pressure or diabetes. You cannot change or repair anything inside the cell to induce immunity. Immunity is about security.

Let’s go back to the idea of the car city as mentioned above. You are right that vaccination is essentially a matter of security not broken parts. Imagine that the city in which cars move has a large number of narrow, winding streets. That results in the fact that no car can safely travel throughout the city if traveling faster than 50 miles per hour. So, there is a problem of how to enforce the speed limit.

There are several ways to do it. The classical approach, as we all know well, is to install cameras, speed bumps, traffic lights, etc.

Gene therapy solves the issue again in a different way. It changes the program of cars to enforce the regulation.

Does it matter how we achieve compliance with that speed limit?

As I said, in the case of gene vaccination, a clever programmer hacks into the brain of the car and runs his own program in it. Let’s say you know capabilities of all cars, and therefore you know that only sports cars are capable of exceeding the speed limit. Moreover, you know that those cars can exceed the speed limit only if their engine is running at maximum revs.

If you know that, then there is nothing easier for a programmer than to write a simple program disabling the engine from running at maximum revs in those sports cars. That program could be as simple as “disallow maximum engine revs.”

If this program is only running in sports cars, then you won and there are absolutely no worries about safety. Safety is assured with 100% guarantee!

On the other hand, you will have a problem if the same program would be triggered in other cars. Trucks need maximum engine revs to get up a hill. Small cars with under-powered engines need maximum engine revs to accelerate on a straight street — otherwise they would block traffic due to slow speed, etc.

In addition, you need to be able to ensure that the program arrives at a given car intact. Even the smallest change in the program can destroy a car — such as missing just one word. Does anyone know what would follow after uploading a program “do not allow engine revs” instead of “do not allow maximum engine revs”.

All of us know that, in everyday life, even smaller linguistic changes can have big effects, such as to tell someone to squeak instead of to speak.

We see that the programmer must ensure that the program must be uploaded only to specific cars and the program must be intact!

It seems that, in the case of genetic Covid-19 vaccination, neither condition is met. Put plainly, it seems that we do not control which cars are being hacked, and neither do we know what program or programs are being uploaded.

3. Why do you think we don’t know what cars are going to be hacked?

I’m sorry, it’s not that we have no idea where the Covid-19 vaccine vectors (modified viral) and mRNA vaccines go. The problem is that those genetic vaccines spread into virtually every tissue in the body. 

A study performed on the Pfizer mRNA vaccine investigated this issue. The study lasted for two days. It was found that the largest amount of vaccine remained at the site of injection. No surprise. The surprise was that other major sites of vaccine delivery were the liver and spleen. It is also noteworthy that there was a 118-fold increase in the concentration of the vaccine in the ovaries throughout the two  days for which this study lasted. A gradual increase in the amount of vaccine was demonstrated in other tissues in the body as well. The most surprising finding was that the vaccine penetrated into all tissues investigated, heart, salivary glands, lungs and brain included (1).

We should also ask for how long is the vaccine active in the body? The active product of any Covid-19 gene therapy is called the spike protein. An earlier study showed the presence of the spike protein in blood up to 29 days after the first shot of the mRNA vaccine (2). A later study found that significant amounts of this product can be detected in the blood of vaccinated people 4 months after the second dose (3)! We do not know when production of this spike protein in the body stops. We also do not know for how long specific cells, like liver, brain or ovarian cells create this spike protein, and neither do we know for how long this product is released from those cells into the blood stream.

We should also ask how blood from blood donors is checked and how organs from organs donors are checked for this spike protein presence, since it has been demonstrated that spike is harmful.

As for the second type of genetic vaccines, the so-called vector vaccines – modified viruses, e.g. AstraZeneca, the situation is not much better either. Presence of this type of vaccine in brain tissue is mentioned in a study published in Toxicology Reports from September 2021 (4).

4. Why do you think we do not know what program is uploaded and started?

I suppose this question is of importance especially for mRNA genetic vaccines. A warning report dealing with this issue was published by the leading medical journal British Medical Journal. The amount of unapproved – truncated and modified – forms of genetic information in Pfizer vaccines used during clinical trials was 22%.  The amount of unapproved mRNA rose up to 45% in batches intended for mass vaccination. Later it decreased to between 25-30% (1). Notice that this is still higher than in trial batches.


What should be of concern is the fact that the EMA warned about the impact of those undeclared – truncated and modified – forms of genetic information in the Pfizer vaccine but later the EMA concluded that the quality of the vaccine could be considered sufficient in the context of the urgency of the pandemic (2). Should that statement mean that, if there would be no pandemic, those batches would not be allowed to be used?

I myself asked the State Institute of Drug control of the Czech Republic – a member of the EMA since the Czech Republic is an EU country – what´s the exact composition of mRNA in mRNA genetic vaccines (3)? I directly asked them to provide me with a list of truncated and modified mRNAs and their amounts in vaccines. As you may remember, there could be a huge difference in the impact of those mRNAs if there is even a small change in any of them. The drug regulator was unable to provide me with this information. Moreover, the drug regulator stated no interest in investigating the impact of those mRNAs on cell functioning and the health of people. I expect the same to be the position of the EMA and the FDA.
5. Do we at least know how long it takes for the cell do get rid of the product that is produced due to Covid-19 gene vaccination?

This is a very serious question that should be part of any discussion about Covid19 gene vaccination.

As early as the spring of 2020, studies began to emerge suggesting that the same protein as that which is formed after vaccination, spike protein, contains some parts that are to be found in proteins that trigger diseases such as Alzheimer’s disease. There is no way to cure such diseases at the moment. In addition, those parts have been shown to play a role in infectivity of the Covid-19 virus (1). A year later, a team of experts from India and the UK took up the question once again. The team searched whether or not this protein, the spike protein, is capable of initiating the same process as observed in Alzheimer’s disease.

The result was striking and clear.  It was demonstrated that the same protein as found in the virus was formed in the body after vaccination, and that it has this ability (2). I would point out that the Japanese package insert for the Moderna vaccine (Takeda/Moderna vaccine) dated August 2021 directly states that this vaccine contains instructions for making all of the protein – the spike protein (3) not just some parts of it. Therefore, the conclusion made by the British-Indian team must be taken very seriously. In addition, a study published in July 2021 demonstrated the presence of a portion of this protein – the S1 subunit – in blood cells of some patients who suffered severe and long-term Covid-19 fifteen months post-infection. No other parts of the virus were detected (4,5).

I will repeat myself now, but when considering potential long-term risks of Covid-19 gene vaccination that may manifest years or even decades after administration of gene vaccines, it is important to keep in mind that the study conducted by Pfizer clearly demonstrated the spread of the gene vaccine into all tissues in the body. The same can be expected for vector vaccines as indicated by detection of the vector virus in the brain as mentioned above.

So, after vaccination, this protein, the spike protein, is produced in all the tissues of the body and not just in certain cells as is the case in a natural infection. The question that thousands of scientists and physicians like Prof. Elias Alexander, Peter McCullough, Howard Tenenbaum (5) are asking is: what can this protein do in all those cells many years post-vaccination?

The fact that we do not know the answer does not necessarily mean that it will lead to a disaster, but it certainly means that drug regulators like the FDA, EMA, WHO and all the governments around the world must have answers to those questions. Surely, they had investigated those questions much prior to the start of the massive gene vaccination programs?

6. What you say is one thing, but there are a number of experts speaking in the media and they are highlighting the benefits of Covid-19 vaccination. So, what should I think about it?

Reuters News Agency released a report warning that 167 million refugees around the world are at risk of not being vaccinated against Covid-19 because pharmaceutical companies would not be covered by legal immunity in post-vaccination injuries. Those companies could be forced to pay compensation for such injuries if those were to happen to refugees (1).  In contrast to refugees, native citizens in the US and the EU have no real way to be compensated by pharmaceutical companies for post-vaccination injuries (2,3). Draw your own conclusion.

7. Is there anything else we should know about genetic vaccine technology?

Certainly. For example, that the safety and effectiveness of mRNA vaccines depends not only on what genetic information the vaccine contains but also on the way the mRNA is packed.

mRNA in vaccines is packed into lipid nanoparticles (LNP). Those LPN aggregate to create small particles. Small differences in size, shape and arrangement of those particles — mRNA packed in LNP — may substantially alter the properties of vaccines, such as stability, activity, distribution, circulation times and even the way the immune system responds to the vaccine (1).

It is also important to remember that vaccines are not made in one factory, but rather they are produced by a number of different manufacturers. It is possible that subtle differences in the manufacturing process can have a major impact on the safety and efficacy of vaccines depending on which factory a given batch of vaccine originates from. Michael Yeadon, former vice president of Pfizer, and his team analyzed databases registering vaccine injuries. They demonstrated that vaccine batches differ dramatically in reported safety (2). There could be many reasons for reported safety difference such as reporting bias. Nevertheless, there is absolutely a strong reason to investigate Yeadon´s team findings in more detail.

Dramatic changes in storage and transportation of Pfizer mRNA vaccines have been made recently. It was known that, once thawed, the vaccine could be stored in a common fridge up to 5 days (3,4). In May 2021, it was announced by the EMA that the same vaccine could be stored thawed in a fridge up to 31 days (5). To my knowledge there were no published details on how the bio-physico-chemical properties of vaccine particles change after storing the vaccine in a fridge for the 31-day period. So, we do not know whether a vaccine stored in a fridge for 31 days has or has not the same effect on the body as a vaccine stored in fridge for a few hours or up to 5 days.

Unfortunately, the detailed composition of these vaccines is not known (4). The additive, SM 102, was never used before in a vaccine yet it is reported to be used in Takeda/Moderna (6).

It would also be good to know whether gene vaccines can spread from vaccinated to unvaccinated people. It´s of note that the FDA recommended investigating the possibility of shedding of genetically altered organisms – viruses and bacteria – that were manufactured to treat cancer as early as 2015 (7).

The same possibility – shedding – was stressed in the Pfizer clinical trials protocol when testing its own mRNA vaccine. Pfizer assessed contact – through skin and breathing – of an unvaccinated pregnant woman with a vaccinated person or with a person administering the vaccine as exposure to the vaccine, and for this reason all pregnancies of women so exposed should be monitored (8).

8. A word in conclusion:

The purpose of this article is not to prove me right, but rather the opposite — to prove me wrong. My aim is that the FDA, EMA, and other drug regulators and governments will shred all my concerns. None of us should lose hope that government institutions were created for any other reason than to protect our interests, health and welfare. So, it cannot be a problem for those institutions to address openly, truthfully and fully concerns of citizens those institutions are serving for.

Certainly, those institutions orchestrated many teams of scientists who conducted dozens, perhaps hundreds, of studies demonstrating the safety of gene Covid-19 vaccines? Those institutions had not published those studies in major peer-reviewed journals simply because there was no time nor energy to publish them?

Citizens should never forget that, in a democracy, politicians, as well as representatives of the public media and other leaders, are eager to be held legally and morally accountable for their actions. It is up to us, the citizens, to recognize their courage, and to ensure that those people be rewarded as deserved for their modest and unappreciated work.

I urge all readers who might perhaps share my concerns not to be afraid to contact their elected representatives, representatives of drug regulatory agencies, Ministry of Health, etc., and urge them to be transparent and require them to immediately publish all studies they have on Covid-19 vaccination safety.

They will appreciate your interest. They simply must appreciate your interest since we live in a democracy. Surely, they are eager to prove that their democracy is strong and works well. They know you have the right to know and they´ll be happy to answer you.

They know that not addressing your concerns in detail would mean that there is no democracy any more, but that you live under tyranny. They know that openness is the only way to demonstrate that North Korea but not Western countries deny people´s rights.

They will not risk losing your trust. If there is no way to trust politicians, then there is no democracy.

Do you need proof that you live in a democracy? Ask your representatives for answers about the safety of Covid-19 vaccines. An inadequate response would prove that there is no longer a democracy anymore.

Do not be afraid: let’s just ask! See the proof that you live in a democracy yourself! Deeds not words speak for politicians, institutions and people. Keep the faith and everything will be fine in the end!

References:

Lists of studies worth knowing about:

– 40 studies on vaccine efficacy questioning vaccine mandates:

– 146 studies, showing natural immunity superior to vaccine induced immunity:

– 75 studies and articles against school closures:

– more than 150 studies on mask ineffectivness and harms:

– more than 400 studies on failure of compulsory Covid-19 mandates:

About the author

(1) https://www.tandfonline.com/doi/full/10.1080/2162402X.2018.1526614

(2) http://fortynsdevitalisation.cz/

1. Introduction:

(1) https://www.medrxiv.org/content/10.1101/2021.05.23.21257686v1

(2) https://unglossed.substack.com/p/what-happened-in-singapore

(3) https://pubmed.ncbi.nlm.nih.gov/33113270/

(4) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351274/

(5) https://pubmed.ncbi.nlm.nih.gov/34749010/

(6) https://www.nature.com/articles/s41421-021-00329-3

(7) https://pubmed.ncbi.nlm.nih.gov/34696485/

(8) https://www.bloomberg.com/news/articles/2022-01-11/repeat-booster-shots-risk-overloading-immune-system-ema-says

(9) https://europepmc.org/article/PPR/PPR357777

(10) https://vaxnotice.com/ (odkaz mi byl poskytnut přímo prof. Francisem Boylem)

(11) https://www.lifesitenews.com/news/twitter-bans-mrna-pioneer-after-he-warned-about-covid-shots/

(12) https://www.rwmalonemd.com/

(13) https://www.researchgate.net/publication/355581860_COVID_vaccination_and_age-stratified_all-cause_mortality_risk

(14)https://www.cnbc.com/2021/10/08/nordic-countries-are-restricting-the-use-of-modernas-covid-vaccine.html

(15) https://medicalxpress.com/news/2021-10-iceland-halts-moderna-jabs-heart-inflammation.html

(16) https://www.reuters.com/business/healthcare-pharmaceuticals/french-health-authority-advises-against-moderna-covid-19-vaccine-under-30s-2021-11-09/

(17) https://www.sciencedirect.com/science/article/pii/S0264410X21016315

2. Why do you believe that Covid-19 vaccination is gene therapy?

(1) https://www.lifesitenews.com/news/bayer-executive-mrna-shots-are-gene-therapy-marketed-as-vaccines-to-gain-public-trust/

(2) https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473ds1.htm

(3) https://apps.who.int/iris/bitstream/handle/10665/338096/WHO-2019-nCoV-vaccines-SAGE_evaluation-BNT162b2-2020.1-eng.pdf?sequence=1&isAllowed=y

(4) https://www.pfizer.com/science/innovation/gene-therapy/manufacturing

(5) https://medium.com/swlh/mrna-therapy-a-new-form-of-gene-medicine-5d859dadd1e

(6) https://patentimages.storage.googleapis.com/b9/98/3c/5f0d7be2283729/EP2839840A1.pdf

(7) https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Recommendations-for-Microbial-Vectors-Used-for-Gene-Therapy–Guidance-for-Industry.pdf  (pozn. str. 2, citace 2)

3. Why do you think we don’t know what cars are going to be hacked?

(1) https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf  

(2) https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075

(3) https://pubmed.ncbi.nlm.nih.gov/34654691/

(4) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8437699/

4. Why do you think we do not know what program is uploaded and started?

(1) https://www.bmj.com/content/372/bmj.n627

(2) https://pubmed.ncbi.nlm.nih.gov/34312010/

(3) https://rozalio.cz/otevreny-dopis-suklu-s-pozadavkem-dolozeni-studii-zdravotni-nezavadnosti-mrna-vakcin-ci-okamzitemu-zastaveni-ockovani/

5. Do we at least know how long it takes for the cell do get rid of the product that is produced due to Covid-19 gene vaccination?

(1) https://www.preprints.org/manuscript/202003.0422/v1#:~:text=The%20presence%20and%20unique%20distribution%20of%20prion-like%20domains,a%2010-%20to%2020-fold%20higher%20affinity%20for%20ACE2.

(2) https://www.biorxiv.org/content/10.1101/2021.05.29.446267v1

(3) https://www.mhlw.go.jp/content/000791158.pdf

(4) https://www.biorxiv.org/content/10.1101/2021.06.25.449905v3

(5) https://www.drpaulalexander.com/blogs/news/dr-bruce-patterson-et-al-sars-cov-2-s1-spike-protein-found-in-cd16-monocytes-following-acute-sequelae-of-covid-19-at-15-months-after-infection#:~:text=It%20means%20if%20we%20are%20willing%20to%20infer%2C,subunit%29%20or%20similar%2015%20months%20post%20COVID%20vaccination.

6. What you say is one thing, but there are a number of experts speaking in the media and they are highlighting benefits of Covid-19 vaccination. So what should I think about it?

(1) https://www.reuters.com/world/refugees-lack-covid-shots-because-drugmakers-fear-lawsuits-documents-2021-12-16/

(2) https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html

(3) https://www.france24.com/en/live-news/20210420-covid-vaccine-makers-largely-protected-on-side-effects

7. Is there anything else we should know about genetic vaccine technology?

(1) https://pubmed.ncbi.nlm.nih.gov/34312010/

(2) https://howbad.info/index.html

(3) https://www.youtube.com/watch?v=Xw54csbihMQ&t=5963s

(4) https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica

(5) https://www.nasdaq.com/articles/pfizer-covid-vaccine-can-be-stored-up-to-1-month-in-fridges%3A-ema-2021-05-18

(6) https://www.mhlw.go.jp/content/000791158.pdf

(7) https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Design-and-Analysis-of-Shedding-Studies-for-Virus-or-Bacteria-Based-Gene-Therapy-and-Oncolytic-Products–Guidance-for-Industry.pdf

(8) https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf  (page 67 at the bottom)

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