Really appreciate this article. I've been following Safe Blood since I discovered you. I'm deeply concerned about this issue and fear that my local (Canadian) hospital would decline directed donated or autologous donation. How would I go about finding out what my local hospital's policy is?
Hi Nara, to my knowledge you are correct about Canaday. You can call the hospital and ask to know their policies on directed donations, autologous donations, and autotransfusion. Any information of hospital going against the norm in Canada would be welcome news. Much more likely, your option would be medical tourism to the US or further south.
I appreciate your reply. I suspected going to the US would be my only option which isn’t really an option in an emergency. I will certainly share here if I have success with my local hospital.
Our understanding of the science at this time is that shedding is the body’s elimination of spike protein through the skin, breath, etc., not mRNA, or not primarily mRNA, as the immune system recognizes the spike protein as a foreign pathogen that it needs to eliminate. As I understand, it does not do so for the mRNA, which it instead incorporates in the cell—which is the big problem. This of course potentially changes with the new self-replicating mRNA technology or vaccines specifically designed to pass contagiously from the vaccinated through the general population.
Keep your Eye on the Prize - CHD's Petition update....
Gemini said
The primary battleground is not "conspiracy," but administrative law and biochemical manufacturing standards. The FDA’s pushback against the December 2025 petition (FDA-2025-P-6831) and its recent "Refusal-to-File" (RTF) actions in 2026 center on a few critical, high-level objections.
1. The "Standard of Care" Objection
The Direct Quote:
"CBER does not consider the application to contain a trial 'adequate and well-controlled'... because your control arm does not reflect the best-available standard of care in the United States at the time of the study." — Dr. Vinay Prasad, CBER Director, Feb 2026.
The Explanation:
This is the FDA's most aggressive new posture. They are essentially accusing manufacturers—and by extension, the petitioners' target products—of "rigging" their clinical trials. The FDA argues that for a vaccine to be truly "safe and effective" for licensure, it shouldn't just be compared to a placebo (saltwater) or a "standard" dose. Instead, it must be tested against the best current treatment available (like a high-dose flu shot for seniors). By using a "substandard" comparator in trials, the FDA claims the resulting data is scientifically "inadequate" for a full Biologics License Application (BLA).
2. The "Semantic Reclassification" Objection
The Direct Quote:
"The petitioner’s request for reclassification relies on a misinterpretation of agency guidance... mRNA vaccines function as biologics, not gene therapies, due to the lack of genomic integration." — FDA Regulatory Response (Draft), 2026.
The Explanation:
CHD’s petition hinges on the Accardi Doctrine, which legally requires an agency to follow its own rules. CHD points to FDA guidance defining products that "transfer genetic material" as Gene Therapy. The FDA’s objection is a technical "firewall": they argue that "Gene Therapy" requires a permanent change to the host’s DNA. Since mRNA is "transient" (it disappears after a few days and doesn't enter the cell nucleus), the FDA contends it is exempt from the much stricter, multi-decade safety monitoring required for Gene Therapies.
3. The "Process 1 vs. Process 2" Manufacturing Objection
The Direct Quote:
"CBER reviews process and method validation consistent with a product lifecycle approach... minor manufacturing changes supported by data showing comparability [do not require] overly stringent and onerous comparability data." — FDA Guidance on Manufacturing Flexibilities, Jan 2026.
The Explanation:
This addresses Sasha Latypova’s core evidence. She argues that the "clean" batches used in trials (Process 1) were fundamentally different from the "mass-produced" batches given to the public (Process 2), which she claims were contaminated with residual DNA. The FDA’s objection is that they allow for "manufacturing flexibilities." They argue that as long as the manufacturer can show the end products are "comparable" enough, they don't need to redo the clinical trials. They view Latypova’s demand for new trials for every manufacturing change as "onerous" and unnecessary for public health.
4. The "Administrative Circumvention" Objection
The Direct Quote:
"The Citizen Petition process should not be used to circumvent the administrative order process... The proposed revocations should be rejected as they would inappropriately intervene in the practice of medicine." — FDA Notice of Action, late 2025.
The Explanation:
The FDA often objects to the format of these petitions. They argue that a Citizen Petition is meant for small, specific changes (like a warning label), not for the "summary revocation" of a multi-billion dollar license. They view the petition as an attempt to "short-circuit" the law. By framing the petition as a "political" or "practice of medicine" issue rather than a "safety" issue, the FDA can legally dismiss it without ever having to hold a public hearing on the actual manufacturing data.
----
In this case the Judge is the Defendant it appears.
I don't think any of these options -- - Directed donations, Autologous donation, Autotransfusion -- are available in Canada. This is scary because I can only hope and pray that no one in my family ever needs a transfusion. Even as a family member with the same blood type who wants to give blood in a time of need, that option is not available in the public system. We need better advocacy here which requires resources and funds. As the US builds up it's cases, and eventually blood received is tracked (vax or no vax) like other variables, this will begin to create better options for Canada. God Speed to American advocacy.
This is a very important issue and important fight to wage. In Switzerland and all of the EU you can’t get these either. It is ironic that our founder George Della Pietra launched SafeBlood first in Switzerland. There SafeBlood’s primary role is as part of the resistance.
Laura told me today she knows who you are, most likely through Tom. I love that all these people are finding each other. I told Laura how I met you and Kerry.
Stargate (blood tests and mRNA vaccines powered by Open AI, SoftBank, Oracle to “cure cancer…” [caused by COVID shot? 🤔])
+
Genius Act (Digital Currency)
+
REAL ID rollout led by Kristi Noem (intermediate step to national digital ID linked to medical records among other future [digital currency] applications.
+
Genesis Mission (National AI platform linking federal data centers)
+
6G Executive Order with “Implantable technologies” as one of its purposes.
Notice how many nations are following the same exact playbook???
👆Please…Fact Check Me.
Politics in general across the globe appear to be a Hegelian Dialectic moving nations on a tight vector towards something Biblical and catastrophic. The political friction is the force. It is deliberate and intentional and controlled very carefully by the media. Just wait until AI kicks in to full gear. We are on the precipice of an age of unprecedented deception.
Truth is at a premium.
Remember, God governs by Truth because Truth is Life Giving. Because He is Love and Love requires relationship.
When we depart from Truth it leads to chaos, confusion, awkwardness, corruption, delusion, perversion, and death.
It is written:
Revelation 13:16-17 KJV
16 And he causeth all, both small and great, rich and poor, free and bond, to receive a mark in their right hand, or in their foreheads:
17 And that no man might buy or sell, save he that had the mark, or the name of the beast, or the number of his name.
Revelation 18:23 KJV
23 And the light of a candle shall shine no more at all in thee; and the voice of the bridegroom and of the bride shall be heard no more at all in thee: for thy merchants were the great men of the earth; for by thy sorceries were all nations deceived.
Sorceries = Pharmakea
Pharmakeia
A Greek word that means the use of drugs, potions, or spells, and is the etymological root of the modern English word "pharmacy". In ancient Greek and Biblical contexts, it often referred to the use of substances in connection with sorcery, magic, and idolatry.
There is also a multifaceted synergistic layered campaign for “Equity in global depopulation.”
It’s monetized and people are profiting off of it.
Look up how much the Bill and Melinda Gates foundation has invested in vaccines, planned parenthood, LGBTQ ideology, and Big Tech / AI to control and shape information. He’s not the only one…
LGBTQ ideology. “Dignity and respect.” “Love is love.”
(Consider: If you were going to sterilize the next generation through their thoughts/minds, how would you do that? Does an ideology have the power to switch bloodlines OFF? Do we have ideas or do ideas have us?)
Global population reduction. Which is monetized for profit by and for the stakeholders.
It’s ironic how they promote all of the above in western militaries and call it “readiness.”
No judgement or condemnation towards any individuals who subscribe to freedom of choice in the above. I’m just showcasing where it leads in the name of Truth and Love and ultimately Life (vs non-life).
Before we determine where we stand on issues that are up for social debate we should ask: Does this lead to life? Or does it lead to death? What if everyone decided to do it? Perhaps it leads to the death of the human race? Maybe that testifies of the spirit behind it.
Again, God governs by Truth because Truth is Life Giving, because He is Love and Love requires relationship repeating in the form of life.
As we see, when we depart from Truth, it leads to chaos, confusion, awkwardness, corruption, delusion, perversion, and death.
CHOOSE LIFE. It is optional. And there’s still time.
Very excited to follow Dr Ohlers and his research here 🙌
Really appreciate this article. I've been following Safe Blood since I discovered you. I'm deeply concerned about this issue and fear that my local (Canadian) hospital would decline directed donated or autologous donation. How would I go about finding out what my local hospital's policy is?
Hi Nara, to my knowledge you are correct about Canaday. You can call the hospital and ask to know their policies on directed donations, autologous donations, and autotransfusion. Any information of hospital going against the norm in Canada would be welcome news. Much more likely, your option would be medical tourism to the US or further south.
I appreciate your reply. I suspected going to the US would be my only option which isn’t really an option in an emergency. I will certainly share here if I have success with my local hospital.
How do you know unvaccinated donors have not gotten MRNA by shedding?
Our understanding of the science at this time is that shedding is the body’s elimination of spike protein through the skin, breath, etc., not mRNA, or not primarily mRNA, as the immune system recognizes the spike protein as a foreign pathogen that it needs to eliminate. As I understand, it does not do so for the mRNA, which it instead incorporates in the cell—which is the big problem. This of course potentially changes with the new self-replicating mRNA technology or vaccines specifically designed to pass contagiously from the vaccinated through the general population.
These self- replicating vaccines for pets are a real concern fearing they will shed to humans.
Keep your Eye on the Prize - CHD's Petition update....
Gemini said
The primary battleground is not "conspiracy," but administrative law and biochemical manufacturing standards. The FDA’s pushback against the December 2025 petition (FDA-2025-P-6831) and its recent "Refusal-to-File" (RTF) actions in 2026 center on a few critical, high-level objections.
1. The "Standard of Care" Objection
The Direct Quote:
"CBER does not consider the application to contain a trial 'adequate and well-controlled'... because your control arm does not reflect the best-available standard of care in the United States at the time of the study." — Dr. Vinay Prasad, CBER Director, Feb 2026.
The Explanation:
This is the FDA's most aggressive new posture. They are essentially accusing manufacturers—and by extension, the petitioners' target products—of "rigging" their clinical trials. The FDA argues that for a vaccine to be truly "safe and effective" for licensure, it shouldn't just be compared to a placebo (saltwater) or a "standard" dose. Instead, it must be tested against the best current treatment available (like a high-dose flu shot for seniors). By using a "substandard" comparator in trials, the FDA claims the resulting data is scientifically "inadequate" for a full Biologics License Application (BLA).
2. The "Semantic Reclassification" Objection
The Direct Quote:
"The petitioner’s request for reclassification relies on a misinterpretation of agency guidance... mRNA vaccines function as biologics, not gene therapies, due to the lack of genomic integration." — FDA Regulatory Response (Draft), 2026.
The Explanation:
CHD’s petition hinges on the Accardi Doctrine, which legally requires an agency to follow its own rules. CHD points to FDA guidance defining products that "transfer genetic material" as Gene Therapy. The FDA’s objection is a technical "firewall": they argue that "Gene Therapy" requires a permanent change to the host’s DNA. Since mRNA is "transient" (it disappears after a few days and doesn't enter the cell nucleus), the FDA contends it is exempt from the much stricter, multi-decade safety monitoring required for Gene Therapies.
3. The "Process 1 vs. Process 2" Manufacturing Objection
The Direct Quote:
"CBER reviews process and method validation consistent with a product lifecycle approach... minor manufacturing changes supported by data showing comparability [do not require] overly stringent and onerous comparability data." — FDA Guidance on Manufacturing Flexibilities, Jan 2026.
The Explanation:
This addresses Sasha Latypova’s core evidence. She argues that the "clean" batches used in trials (Process 1) were fundamentally different from the "mass-produced" batches given to the public (Process 2), which she claims were contaminated with residual DNA. The FDA’s objection is that they allow for "manufacturing flexibilities." They argue that as long as the manufacturer can show the end products are "comparable" enough, they don't need to redo the clinical trials. They view Latypova’s demand for new trials for every manufacturing change as "onerous" and unnecessary for public health.
4. The "Administrative Circumvention" Objection
The Direct Quote:
"The Citizen Petition process should not be used to circumvent the administrative order process... The proposed revocations should be rejected as they would inappropriately intervene in the practice of medicine." — FDA Notice of Action, late 2025.
The Explanation:
The FDA often objects to the format of these petitions. They argue that a Citizen Petition is meant for small, specific changes (like a warning label), not for the "summary revocation" of a multi-billion dollar license. They view the petition as an attempt to "short-circuit" the law. By framing the petition as a "political" or "practice of medicine" issue rather than a "safety" issue, the FDA can legally dismiss it without ever having to hold a public hearing on the actual manufacturing data.
----
In this case the Judge is the Defendant it appears.
The FDA needs to recuse itself.
I don't think any of these options -- - Directed donations, Autologous donation, Autotransfusion -- are available in Canada. This is scary because I can only hope and pray that no one in my family ever needs a transfusion. Even as a family member with the same blood type who wants to give blood in a time of need, that option is not available in the public system. We need better advocacy here which requires resources and funds. As the US builds up it's cases, and eventually blood received is tracked (vax or no vax) like other variables, this will begin to create better options for Canada. God Speed to American advocacy.
This is a very important issue and important fight to wage. In Switzerland and all of the EU you can’t get these either. It is ironic that our founder George Della Pietra launched SafeBlood first in Switzerland. There SafeBlood’s primary role is as part of the resistance.
You, Laura Kasner, and Tom Haviland should become acquainted (if you already aren't) because your work is linked.
I don’t know Laura yet, but consider Tom a great friend!
Laura told me today she knows who you are, most likely through Tom. I love that all these people are finding each other. I told Laura how I met you and Kerry.
Warp Speed (COVID shot)
+
Stargate (blood tests and mRNA vaccines powered by Open AI, SoftBank, Oracle to “cure cancer…” [caused by COVID shot? 🤔])
+
Genius Act (Digital Currency)
+
REAL ID rollout led by Kristi Noem (intermediate step to national digital ID linked to medical records among other future [digital currency] applications.
+
Genesis Mission (National AI platform linking federal data centers)
+
6G Executive Order with “Implantable technologies” as one of its purposes.
Notice how many nations are following the same exact playbook???
👆Please…Fact Check Me.
Politics in general across the globe appear to be a Hegelian Dialectic moving nations on a tight vector towards something Biblical and catastrophic. The political friction is the force. It is deliberate and intentional and controlled very carefully by the media. Just wait until AI kicks in to full gear. We are on the precipice of an age of unprecedented deception.
Truth is at a premium.
Remember, God governs by Truth because Truth is Life Giving. Because He is Love and Love requires relationship.
When we depart from Truth it leads to chaos, confusion, awkwardness, corruption, delusion, perversion, and death.
It is written:
Revelation 13:16-17 KJV
16 And he causeth all, both small and great, rich and poor, free and bond, to receive a mark in their right hand, or in their foreheads:
17 And that no man might buy or sell, save he that had the mark, or the name of the beast, or the number of his name.
Revelation 18:23 KJV
23 And the light of a candle shall shine no more at all in thee; and the voice of the bridegroom and of the bride shall be heard no more at all in thee: for thy merchants were the great men of the earth; for by thy sorceries were all nations deceived.
Sorceries = Pharmakea
Pharmakeia
A Greek word that means the use of drugs, potions, or spells, and is the etymological root of the modern English word "pharmacy". In ancient Greek and Biblical contexts, it often referred to the use of substances in connection with sorcery, magic, and idolatry.
https://www.youtube.com/watch?v=PslOp883rfI
Still reading?
There is also a multifaceted synergistic layered campaign for “Equity in global depopulation.”
It’s monetized and people are profiting off of it.
Look up how much the Bill and Melinda Gates foundation has invested in vaccines, planned parenthood, LGBTQ ideology, and Big Tech / AI to control and shape information. He’s not the only one…
Let’s view the deceptive equation:
Vaccines. “Safe and Effective.”
+
Planned Parenthood [abortion]. “Reproductive care.”
+
LGBTQ ideology. “Dignity and respect.” “Love is love.”
(Consider: If you were going to sterilize the next generation through their thoughts/minds, how would you do that? Does an ideology have the power to switch bloodlines OFF? Do we have ideas or do ideas have us?)
+
Censorship. “Hate Speech, misinformation/disinformation.”
=
Global population reduction. Which is monetized for profit by and for the stakeholders.
It’s ironic how they promote all of the above in western militaries and call it “readiness.”
No judgement or condemnation towards any individuals who subscribe to freedom of choice in the above. I’m just showcasing where it leads in the name of Truth and Love and ultimately Life (vs non-life).
Before we determine where we stand on issues that are up for social debate we should ask: Does this lead to life? Or does it lead to death? What if everyone decided to do it? Perhaps it leads to the death of the human race? Maybe that testifies of the spirit behind it.
Again, God governs by Truth because Truth is Life Giving, because He is Love and Love requires relationship repeating in the form of life.
As we see, when we depart from Truth, it leads to chaos, confusion, awkwardness, corruption, delusion, perversion, and death.
CHOOSE LIFE. It is optional. And there’s still time.
Deuteronomy 30:15-20
John 14:6
https://youtu.be/obRG-2jurz0?feature=shared