Debt Rattle September 25 2021
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Winslow Homer Salt Kettle, Bermuda 1899 • The Spartacus Letter (DocDroid) • Once Upon A Time… (Denninger) • UK Report: Case-Hospitalisation R
[See the full post at: Debt Rattle September 25 2021]I wanted to clear up a mistaken assumption made the other day in the comment section. There are so many attacks on people who do not want the vaccines that we must take care to use only reliable information. This is a small thing, but I think it should be noted.
Bolding in the below is mine. I checked the NIH website (which is very difficult to use, btw) regarding their supposed approval of Ivermectin. The antivirals listed are “approved or under evaluation”; i.e., not all of them are fully approved. Says so right in the heading at the top of the page:
Table 2e. Characteristics of Antiviral Agents That Are Approved or Under Evaluation for the Treatment of COVID-19
Under the Dosing Regimens column, there is the note that the “doses listed here are for approved indications or from reported experiences or clinical trials.”
Under Ivermectin specifically, it reads, “The dose most commonly used in clinical trials is IVM 0.2–0.6 mg/kg PO given as a single dose or as a once-daily dose for up to 5 days.”
Of the three antivirals listed by NIH, only Remdesivir is approved. You can see that by reading the column titled “comments and links to clinical trials”. The other two (Ivermectin and Nitazonanide) are not approved, and you are given a link to see the clinical trials. (Remdesivir wrecks your kidneys. I wouldn’t take it, but hey – maybe that’s just me.)
I found that there are currently three (only 3!) trials on Ivermectin currently going on in the US. All 3 of them are still recruiting test subjects, so I presume they haven’t gone very far in their research yet.
https://www.covid19treatmentguidelines.nih.gov/tables/table-2e/
teri,
There is a clear contradiction in saying “we must take care to use only reliable information” and then pointing to the NIH website.
Re. 100% of NSW hospitalisation cases were vaccinated.
To put that 100% hospitalised figure in perspective only 50% of the entire NSW population is fully vaccinated and 75% have had one dose so the claim is risible on that basis alone.
Digging deeper…
The tweet is dated 25th September and the “Breaking News” banner claims 141 new cases presumably for the previous day or at least contemporaneous with 25th.
141 is incorrect, there were in fact 1,007 new locally acquired cases on 24th Sept NSW.
Here is the actual video on 25th September of the same health officer clearly stating that the 24th daily figure was 1,007 at the start of the video near the 7 second mark.
Given the obvious intention of the author of the tweet it seems to me it’s sheer invention and designed to deliberately mislead anyone ignorant of the true situation in Australia.
As an Australian I’m mightily interested in the vaccination status of the hospitalised in this country and as a very long term reader of this blog I’m equally interesting in trying to get real figures out of the mass of misinformation.
I can’t quickly find the actual % vaxed in hospital in NSW on that date but at a guess it would be no more than 5% at the very most. When I get time I’ll see if I can come up with something better than a guess. Regardless, that tweet about 100% is utter crap.
teri is correct, however – only Remdesivir has the word “approved” in the right-hand column. Let the obfuscation continue since, clearly, that table could have division headings that note which are “approved” and which are in “clinical trial” stage. I hate the government. They’ve destroyed what little credibility they used to have. I’ll never trust any of them again.
I’m also tired of the fact those who question the accepted vaccination/treatment narrative “must take care to use only reliable information.” The other side doesn’t have to do that, now do they. F ’em.
@Ilargi, “There is a clear contradiction in saying “we must take care to use only reliable information” and then pointing to the NIH website.”
LOL. You are right about that, of course. But the misinformation I was pointing out was the idea that NIH had approved of Ivermectin. They did not, and they did not try to say that they had. We just didn’t read the entire wording they used, so this particular little detail was a mistaken assumption made in haste – not the fault of NIH.
There is a whole freaking slew of really important stuff that is their fault, and the fault of the entire governmental apparatus, the media, and the pharma companies, etc.
What happened to Dr. D? I miss my daily portion of disparaging sardonic irony with a large side of acerbic sarcasm.
@ teri
“I wanted to clear up a mistaken assumption made the other day in the comment section.
I found that there are currently three (only 3!) trials on Ivermectin currently going on in the US. All 3 of them are still recruiting test subjects, so I presume they haven’t gone very far in their research yet. “
@ upstateNYer
“teri is correct, however – only Remdesivir has the word “approved””A list of clinical trials is available here:
Ivermectin
https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=ivermectin&cntry=&state=&city=&dist=&Search=Search
78 Studies found for: ivermectin | COVID-19
Showing: 1-10 of 78 studies 10 studies per pagepage #1 has 4 completed trials
page #2 has 5 completed trials
page #3 has 5 completed trials
page #4 has 4 completed trials
page #5 has 1 completed trials
page #6 has 3 completed trials
page #7 has 3 completed trials
page #8 has 1 completed trialsOf course, those 26 trials were not done in the USA and therefore you omitted to mention them.
(If not in the USA then they cannot be good. Therefore, not approved. Therefore, ignored)
I would prefer to take Ivermectin instead of the approved Remdesivir.
I would not prefer to take the vaccines because there are other options that can be as effective.
( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833340/#!po=34.9057
Antihistamines and azithromycin as a treatment for COVID-19 on primary health care – A retrospective observational study in elderly patients Published online 2021 Jan 16)No, I omitted them because I was specifically looking for clinical trials in the US to see if we were even researching this medicine. I am surprised the US isn’t doing more trials considering the success other countries seem to have had with Ivermectin.
I just checked again and the clinical trials.gov website has 8 studies listed in the US now – not 3. Of the 8, one has been withdrawn, and one does not mention ivermectin within its parameters, so there are really only 6 currently. In the US.
I did not check worldwide studies because I wanted to know if the medical people in the US are even interested in ivermectin, not because I think studies done in other countries are not as “good” as the US. My point was, in fact, that we (in the US) are derelict by ignoring the possible use of this medicine. Please don’t put words in my mouth. Geez.
And I agree with you in that I too say, “I would prefer to take Ivermectin instead of the approved Remdesivir. I would not prefer to take the vaccines because there are other options that can be as effective.”
Hey sinnycool, I couldn’t handle not knowing so I googled the stats and found July 25th.
https://www.health.nsw.gov.au/news/pages/20210725_00.aspx
Click through to find the video.I was relieved and disturbed. Video at around 6:30 mark is same as tweet.
It’s ok. teri was pointing out a nuance that we overlooked in our haste. It’s appreciated, teri. 🙂
Remdesivir doesn’t work to do much of anything, really, and it’s dangerous. Didn’t Remdesivir studies show it only shortens hospital stays by like 2 days? I would never take it.
I miss Dr D, too. Maybe his real life is taking his attention away from TAE readers’ needs. lol
Karl D has yet another good post this morning. Opening lines:
“The number of people calling for unvaxxed folks to be denied medical care, even doctors, is stunning.
Do you have any idea where this leads?”In case people have trouble figuring out where this could lead, even just RE: covid:
1) 1 or 2 injections (depending on brand) – you’re fully vaccinated
2) no vaccination – no medical care for you
3) add booster #1 – you’re fully vaccinated
4) no booster #1 – you’re unvaccinated. No medical care for you
5) add booster #2 – you’re fully vaccinated
6) no booster #2 … see 4) above … rinse, repeat, rinse, repeatJeepers. Humans certainly win the stupidity prize among earth’s species, don’t they?
sinnycool, a friend looked it up, it’s from July 26
Nice job cutting it up to change the message. Bonus points for leaving put his clarification. pic.twitter.com/Umyo3XX9qk
— Bill Wellford (@bill_wellford) July 27, 2021
@ teri – “I am surprised the US isn’t doing more trials considering the success other countries seem to have had with Ivermectin.”
Hahahaha – that surprises you?
You have some catching up to do!
There appears to be an epidemic of fully vaccinated people with COVID telling you to get vaccinated so you don't get COVID.
— Black in the Empire (@blackintheempir) September 25, 2021
The problem with psychopathic gaslighting techniques is it makes one second guess oneself. It is designed to work that way. We should be a little easier on ourselves. These kinds of psyops are not particularly pleasant or easy to go through. As we all know, government has been spinning this particular game on us for centuries. It’s not new or innovative (hint to deep state actors – must try harder)
We should congratulate ourselves for getting a masterclass on agitprop-in-action. It’s real life folks. Kinda disappointing when you see it up close and personal like this. I was expecting much more (what with the unlimited resources that they have at their disposal) All we needed in the 21st century was an internet connection and a few good people who know how to think for themselves.
That’s the advantage of this occuring right here, right now. Despite their gaming the system to own all the media, influencing virually all the social networks that exist, buying out every politician they can along woth the banks, pharmaceuticals and the like, they never figured out that information is free and everywhere. A few good people can join the dots even without the incalculable wealth they have amassed or stolen.
• UK Report: Case-Hospitalisation Rate 49% Higher Among Fully Vaccinated (TE)
That article is making good points, but it’s silent about the last two columns in the tables appearing in the article, which show the rates per 100,000. The article looks at the total numbers (combining all age groups, each with a different percentage being vaccinated), but the rates per 100,000 (broken down between age groups) should give a better picture (as long as the data is reliable, more about that later). The last two column of the Tables 2&3 show these rates per 100,000.
In Table 2 (shown above), the number of Covid cases per 100,000 are higher for those with 2 vaxx doses (compared to those with no vaxx doses) for ages 40 and older. The situation is reversed for the under-40 age groups.
This data shows that for people age 40 and older, the vaxx shots are actually associated with a higher likelihood of coming down with a Covid infection. For people under age 40, the data shows the opposite.
In Table 3 (shown above), the number of Covid hospitalizations per 100,000 are lower for those with 2 vaxx doses (compared to those with no vaxx doses) for all age groups. These rates seems to contradict the overall numbers examined in the article. But, the government data includes this caveat about the “per 100,000” rates:
“Interpretation of the case rates in vaccinated and unvaccinated population is particularly susceptible to changes in denominators and should be interpreted with extra caution.”
Sounds like another way to say those rate numbers (per 100,000) are very shaky. The “denominators” would presumably be the population numbers for the various age groups when segregated by vaxx status. The caveat was given for the case rates, but the hospitalization rates are presumably just as shaky, since they have the same denominators.
I’ve only read a few pages so far, but I can’t emphasise enough how educational and important is the info contained in the Spartacus Letter.
Nice find Raúl.
Two neutral to negative articles:very worth reading regarding ivermectin.
Swiss Policy Research
Cochrane lLibrary
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015017.pub2/full?highlightAbstract=ivermectinI believe at this time IVM has almost no negative consequences, so I am using the horse paste as a preventative.
It’s okay. We just need to know our enemies….and I am not your enemy. Here, a music break on me.
I keep thinking that here’s where we are:
Freakin’ David Byrne, man.
First comment under this video (as I watched it a few minutes ago) was from a year ago and reads,“This is my quarantine workout. I play this video 3 times in a row and do whatever the heck David Byrne is doing. I became so buff my shoulders expanded by 3 times and now my head looks smaller.”
Another informative read:
“The Dangers of Covid-19 Booster Shots and Vaccines: Boosting Blood Clots and Leaky Vessels”
Technically alcohol is the solute, water is the solvent, and what we end up drinking is the solution.
In these times of misinformation we must strive for accuracy in everything we say 🙂The usual suspects – well worth watching:
“8 prominent doctors & scientists engage in a remarkable exchange”
I notice that apart from Dr. D. being AWOL, also V. Arnold has failed to put in an appearance today, so let me comment on the art in his place, which I find absolutely inspirational; the way Homer has captured the shimmering water with just a few simple brush strokes is simply stunning.
In other news, today is day one of the fascist corona pass to access cafés, restaurants, museums etc. in my normally so wonderfully tolerant country of the Netherlands. I think it’s an absolute disgrace to discriminate and divide the people and to pretend it’s all about health as our (out of office, nota bene) government has done, even though this runs counter to the very first article of the constitution! Just what is the point of having a king if he can’t stand up to such an egregious abuse of power when it matters? No doubt he’s off with his chums shooting wild boar and deer at the moment on public property which he’s closed off specially for the next three months.
Nuremberg 2.0 can’t come quickly enough as far as I am concerned and if the French have a guillotine or two they’re not using at the moment then perhaps they wouldn’t mind lending them to us.
/rant-off
About the UK data, I just noticed Norman Fenton’s recent blog post which delves deeper into the data, consolidates all the vaxxed categories into one (for comparison to the no-vaxxed), and concludes “The UK Government’s own data does not support the claims made for vaccine effectiveness/safety.”
https://probabilityandlaw.blogspot.com/2021/09/all-cause-mortality-rates-in-england.html
Vaxx (and investment advice, too!) peddler at your service:
“We have the experience and the infrastructure to play a leading role in administering booster shots to eligible populations,” said Troyen A. Brennan, M.D., MPH, Executive Vice President and Chief Medical Officer of CVS Health. “We also continue to make it as convenient as possible for the unvaccinated to receive their first doses.”
… btw, CVS performance:
https://ca.finance.yahoo.com/quote/CVS/Best,
F.S.NZ Vaccine Adverse Effects latest report #27 published 22 Sept
https://www.medsafe.govt.nz/COVID-19/safety-report-27.aspAs I posted 2 weeks ago with the huge increase in vaccine uptake due to the ‘Deadly Delta Outbreak” (1 death – 90 y.o. with severe comorbidities Sept 4) I expected a huge increase in reported deaths.
The previous report was to 28 August, 2 weeks into the ‘DDO’, so not really time for many new reports to be entered. That week the total was 3,294,792 cumulative doses (+ 539,675 for the week)
“There were 1,791 non-serious and 47 serious reports this week. Sadly, three of these serious reports reported on deaths.”The latest report to end of Sept 4 the total doses given 3,857,146 (+ 562,354 for the week):
“There were 2,692 non-serious and 85 serious reports this week.-
Sadly, 14 of these serious reports were notifications of deaths
. Any possibility of a causal link is investigated as part of our routine investigations and no new safety concerns with the Comirnaty vaccine were raised by these reports.”
But is this reported ANYWHERE in our so called news sites or normal media – not a word (nor for any other countries stats).
Apparently this government dictated slaughter is only new once the Chief Coroner accepts the fact the a death is ‘likely’ linked.
So far 1 out of 54 “was likely due to vaccine induced myocarditis (awaiting Coroner’s determination)”
– 26 of these deaths are unlikely related to the COVID-19 vaccine
– 9 deaths could not be assessed due to insufficient information
– 18 cases are still under investigation.So far 27 Covid-19 ‘linked’ deaths – either died within 28 days of a positive PCR test, or determined by physicians examination to have symptoms consistent with Covid-19.
1 Of these since the Dreaded Delta came to NZ.
54 Comirnity linked deaths, 17 of these reported since the week including 17 August when the first case of Deadly Delta was reported.Something is terribly, terribly wrong
You can sit on the terrace of the cafe without pass, but to go pipi you need it! Wildplassen wordt het volgende item! 🙂
My mention above of the “no-vaxxed” led me to imagine a medicinal product called NoVaxx (which implies a combination of Vaccination with either Nova or Novel, or No as in None). Two shots of NoVaxx would protect you as much as the current Covid “vaccines,” especially if some ivermectin is part of the formulation.
My mockup photo of NoVaxx:
Excerpts from the Safety Data sheet for Comirnity used in NZ. (emphasis mine)
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
COMIRNATY™ COVID-19 VACCINE 0.5 mg/mL concentrated suspension for injection.1 dose (0.3 mL) contains 30 micrograms of BNT162b2 [mRNA] (embedded in lipid
nanoparticles).
The active ingredient is a single-stranded, 5’-capped messenger RNA (mRNA) produced using
a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral
spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).4. CLINICAL PARTICULARS
4.1 Therapeutic indications
COMIRNATY has provisional consent (see section 5.1) for the indication below:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV2, in individuals 12 years of age and older.The preferred site of administration is the deltoid muscle of the upper arm.
Do not inject COMIRNATY intravascularly, subcutaneously or intradermallyDuration of protection
The duration of protection afforded by COMIRNATY is unknown as it is still being determined
by ongoing clinical trials.4.5 Interactions with other medicines and other forms of interactions
No interaction studies have been performed.
Concomitant administration of COMIRNATY with other vaccines has not been studied.4.6 Fertility, pregnancy and lactation
Fertility
In a combined fertility and developmental toxicity study, female rats were intramuscularly
administered COMIRNATY prior to mating and during gestation (4 full human doses of 30 μg
each, spanning between pre-mating day 21 and gestation day 20). SARS-CoV-2 neutralising
antibodies were present in maternal animals from prior to mating to the end of the study on
postnatal day 21 as well as in fetuses and offspring. There were no vaccine related effects on
female fertility and pregnancy rate.
Pregnancy
There is limited experience with use of COMIRNATY in pregnant women. Animal studies do
not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal
development, parturition or post-natal development (see Fertility). Administration of
COMIRNATY in pregnancy should only be considered when the potential benefits outweigh
any potential risks for the mother and fetus
Lactation
It is unknown whether BNT162b2 [mRNA] is excreted in human milk.
(But then we get huge pressure for pregnant or those wanting to get pregnant to get the jab anyway)
https://www.nzherald.co.nz/nz/covid-19-coronavirus-delta-outbreak-pregnant-women-delay-getting-vaccine-worrying-misinformation/P3MQOQ5ZUNPN4YAKEUC6HEMESI/Covid 19 coronavirus Delta outbreak: Pregnant women delay getting vaccine – worrying misinformation
Fertility doctors are worried about a significant number of pregnant women delaying their Covid vaccination as a result of “fake news” that suggests it could harm their unborn baby.They are also seeing couples putting off their jabs out of fear it could prevent their chance of conceiving a baby.
Auckland obstetrician and gynaecologist Olivia Stuart told the Weekend Herald pregnant women were in more danger during the Delta outbreak by not getting the vaccine than if they had one.
“Most of our day involves talking our patients into getting the vaccine … it’s worrying to think there are women out there who weren’t getting the correct information at all.”
The Ministry of Health had also advised the Pfizer vaccine is safe for pregnant women and will not affect a person’s genes or fertility.(No mention of possible harm to your unborn or chance to conceive due to the fact that there is NO data on the safety in these cases)
Back to the Safety Sheet:
4.8 Undesirable effects
Summary of safety profile
The safety of COMIRNATY was evaluated in participants 12 years of age and older in 2
clinical studies that included 22,875 participants (comprised of 21,744 participants 16 years of
age and older and 1,131 adolescents 12 to 15 years of age) that have received at least one dose
of COMIRNATY.Some details on Study C4591001:
“Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.” – Whoops there goes your control group as part of the study design!Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023At the time of the analysis of Study C4591001 with a data cut-off of 13 March 2021 for the
placebo-controlled blinded follow-up period up to the participants’ unblinding dates, a total of
25,651 (58.2%) participants (13,031 COMIRNATY and 12,620 placebo) 16 years of age and
older were followed up for ≥4 months after the second doseFollowed up for at least 4 months… and then what?
So our entire ‘The Vaccine is Safe’ narrative is based on 13,031 people receiving two doses and being monitored for at least 4 months. And we can’t compare to the control group because they were all offered the vaccine as part of the study.
But we are promised it is safe and anyone who says otherwise is spreading mis-information, an anti-vaxxer, right wing conspiracy theorist.
Call me what you want, just don’t call me stupidPharmacist Tips on Ordering Ivermectin
“Ivermectin is the gun. Zinc is the bullet”
“We de-worm horses once a year but why not ourselves?”
Welcome to our new world.
Sickening.#Lithuania is the first country in #Europe to fully implement the #COVIDPass.
Is this the world you want for your children? pic.twitter.com/TBMes3UUHa
— Abir Ballan (@abirballan) September 25, 2021
@LudwigVon well, if you‘re not allowed to go inside to follow the call of nature, there is only really one place left, right? I mean, you ARE allowed to conduct your business on the terrace, so to speak, aren’t you? I reckon it‘s a bit simpler if you‘re a man, but hey – desperate times call for desperate measures. 😉
Regarding PSYOPS:
Following the successful pysop of yellow journalism declaring that Spain attacked the USS Maine, (Remember the Maine! To hell with Spain!) politiks & journalism were never the same…
The robber barons became so emboldened by the gullible nature of the public that they unleashed the Creature from Jekyll Island (ie The Federal Reserve), which slowly but surely became the corrupting power that led to TPTB’s defacto capture of the U$ Government.
The 2020 election psyops, the culmination of the coup against Trump, clearly shows that anything is possible with the serfs…
Every announcement from the apparatchiks & quislings in .GOV are clearly lies, mixed with less & less truth, meant to support psyops both current & future.
Just typing these words is depressing as hell, because it’s gotten so bad I fully expect the innocent to suffer under the imperial madness to an extant I do not want to fathom…
My job now is to save, shelter & protect the least of these from poisonous hoards of evil.
FWFS
I’ve been concerned for some time about the mRNA based vaccines and whether they actually modify one’s genes – does a recipient become a Genetically Modified Organism? Is the vaccine a GMO?
- (All emphasis under-lined is mine)
From: Genetic Modification The New Zealand Approach
https://environment.govt.nz/assets/Publications/Files/genetic-modification-nz-approach.pdfGenetic modification (GM) is a technology for altering the genetic make-up (the DNA) of living organisms so they are able to make new substances or perform new or different functions.
Like all organisms new to New Zealand, genetically modified organisms potentially have positive or negative effects on the environment, the economy and our society. This is because different organisms have different characteristics, and their risks and benefits will depend on where and how each organism is used.
- For this reason, New Zealand’s evaluations of genetically modified organisms are based on the principle of case-by-case assessment.
What is a genetically modified organism?
A ‘genetically modified organism’ is a plant, animal, insect or micro-organism whose genetic make-up has been changed using modern laboratory techniques.What can be genetically modified?
… Humans. Genetic modification of human cells has the potential for treating diseases. One approach, gene therapy, delivers ‘corrected’ genes into selected cells in the body to treat diseases caused by an absence of an important gene, such as in cystic fibrosisGENETIC MODIFICATION IN NEW ZEALAND
The Hazardous Substances and New Organisms Act 1996 (HSNO Act) regulates research into and release of all living things that do not already exist in New Zealand, including those that are genetically modified. The HSNO Act applies to anything that can potentially grow, reproduce and be reproduced, whether or not it is also a food or a- medicine.
- Releasing a genetically modified organism in New Zealand without approval is illegal.
- Public input is an important part of this process. All applications to release a genetically modified organism or field test a genetically modified organism in containment must be publicly notified and go through a public consultation process.
GENETICALLY MODIFIED MEDICINES AND FOOD
What genetically modified medicines are sold in New Zealand
Some medicines used in New Zealand are manufactured by a process that uses a genetically modified organism. In the majority of these cases, a bacterium or yeast will be modified to enable it to produce a naturally occurring human protein. The resulting medicine (ie, the protein) will not typically contain any DNA (modified or otherwise), and the protein will be chemically very similar or identical to that normally produced in humans. In other words, while the protein is produced through a process involving genetic modification, the protein itself is not genetically modified. Up to 30 of these types of medicines, such as insulin and human growth hormones, have been approved for use in New Zealand.Some medicines, such as vaccines, may contain live genetically modified organisms but none have yet been approved by the Environmental Risk Management Authority (ERMA) for use in New Zealand.
-
(As of publication date March 2021. Medsafe formally made the decision to provisionally approve the vaccine in New Zealand on 3 February 2021. Obviously the official documentation has not been updated)
What controls are there on medicines?
Medicines must be approved by the Minister of Health under the Medicines Act 1981. Only then can they be distributed or sold as medicines.
If a medicine contains a live organism that has been genetically modified, both the Minister of Health and ERMA (under the HSNO Act) must approve its use.-
(ERMA – Environmental Risk Management Authority was disestablished and replaced by the EPA – Environmental Protection Agency in June 2011)
From the EPA website:
https://www.epa.govt.nz/about-us/our-role-in-covid-19-vaccines/
Our role in approving COVID-19 vaccines
A manufacturer or importer is required to have approval from us if a vaccine contains a new organism or genetically modified organisms (GMOs).Public consultation
If a manufacturer applies to the us to test or release a vaccine containing a new organism or genetically modified organism, our Chief Executive has the discretion to consider such applications under a rapid approval pathway.- Under the rapid approval pathway, there is no public consultation. The final decision is published on our website
.
Pfizer-BioNTech vaccine
Pfizer applied to us to formally determine whether its COVID-19 vaccine is considered a new organism in New Zealand.
The Pfizer-BioNTech COVID-19 vaccine BNT162b2 has been engineered using technologies that can also be used to create genetically modified organisms.Decision-making committee decided it is not a new organism
In February 2021, an EPA decision-making committee examined the characteristics of the Pfizer vaccine, including what it does, how it is made, and whether it could be considered a new organism.-
The committee found that, because the vaccine is unable to replicate itself, it does not meet the definition of a new organism.
- …The vaccine can’t replicate itself…
From:
https://www.epa.govt.nz/community-involvement/science-corner/sars-cov-2-vaccines-and-the-hsno-act/… the spike protein is one of the major proteins that our immune systems recognise to begin to fight off the virus. This is why the leading vaccines are designed to use the spike protein to generate a protective immune response against future infections.
The BNT162b2 vaccine is made up of- (Genetically)
engineered messenger RNA (mRNA) molecules encapsulated in a lipid nanoparticle capsule.
The mRNA in the BNT162b2 vaccine-
contains the genetic code to make one (and only one) protein – the SARS-CoV-2 spike protein.
The thing about normal mRNAs in our cells is that a lot of them get made every day, but most of them are quickly broken down once they’ve done their jobs (some in only a matter of minutes!) and their building blocks are recycled in the cell.
-
Also, since the spike protein mRNA is not an RNA encoded by one of our own genes, it is recognised and targeted by our immune systems to be broken down.
Although we want a strong immune response to the vaccine, we want it to be against the spike protein, and not against its mRNA!
To solve this problem, the- BNT162b2 mRNA has a modified nucleotide building block
that doesn’t affect its ability to function as an mRNA, but instead makes it less of a target for our immune systems. It also turns out that this modification makes the mRNA easier to be deciphered into proteins by ribosomes,
- so they can make more of the spike protein faster.
This means that the spike protein mRNA remains in our cells longer before it’s broken down, and at the same time
- allows more spike protein to be made at a faster rate
.
At the beginning of the RNA code for the spike protein, there’s a special sequence that encodes something called a signal peptide. This sequence tells the cell that the protein the signal is attached to should be shuttled out of the cell. Once it’s out there,- our immune cells recognise the secreted spike protein as foreign, and the immune response begins.
The Pfizer/BioNTech vaccine and the EPA
All the biotechnology that went into making BNT162b2 puts it at an intersection that has EPA at the corner, because one of our jobs is to regulate all genetically modified organisms (GMOs) in Aotearoa. This is part of our job in regulating new organisms under the Hazardous Substances and New Organisms (HSNO) Act.- As I explained above, the Pfizer vaccine has mRNA that was created outside of cells, and this is one of criteria for saying whether something is a GMO
.
But it’s not the only criterion. That “something” also has to be an organism.- This “organism” criterion is why the EPA doesn’t generally regulate RNA, because it is a substance, and not an organism
.
But with the Pfizer vaccine, there’s clearly a lot more going on than just RNA, so a reasonable person at the border responsible for giving the regulatory tick to the vaccine might have some doubt about whether or not they were looking at a GMO.- The remedy for this uncertainty is to ask the EPA. This is because the HSNO Act also allows us to determine whether or not an organism is a new organism – or if something is even an organism at all
, if that is where the question lies.
To ensure the vaccine would not be held up at our border as a potential new organism, Pfizer agreed that going through the statutory procedure to determine if BNT162b2 is a new organism was an appropriate thing to do.
In the EPA’s determination process (which has a lot of moving parts, but I’m cutting a long story short), a
- Decision-Making Committee (DMC) thoroughly considered whether BNT162b2 could be seen as an organism at all. One criterion in the HSNO Act for being an organism is being capable of replicating itself. The DMC decided that the only thing that BNT162b2 was capable of producing was the SARS-CoV-2 spike protein, and not more copies of itself. On this basis, the DMC determined that BNT162b2 did not meet any of the criteria for it to be called an organism.
Hmmm…
So in a lab we create mRNA that has been modified to create a new and novel protein, inject it into people whose cells take in that modified code and begin to make a modified protein. One specifically modified to hide from our innate immune system.
But since the original mRNA was not made in a cell it is not an organism. It is a substance.
A Genetically Modified Substance that causes your cells to replicate said substance and hide itself from your immune system.
What a nice way to get around the law that requires public consultation:
Genetically modify people’s cells to make the Genetically ModifiedOrganismSubstance!Tada! Fixed that pesky law that would prevent the release into our GMO-free environment of the first GMO vaccine, one that has not completed safety trials and is being shown to be hopelessly ineffective.
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