Due Diligence by Sasha Latypova Podcast

This is a Part 1 of a 2-part detailed discussion about the Citizen Petition to revoke BLA licensure for Pfizer and Moderna mRNA shots which I co-authored with Children’s Health Defense, including Ray Flores, Kim Mack Rosenberg, Mary Holland and Brian Hooker. The “citizen petition” mechanism is exercised through the Food and Drug Administration (FDA) under 21 CFR § 10.30 and tracking thereof via the federal portal Regulations.gov.

This petition received 100K+ public comments in one day after it was filed on December 8 and posted on December 9, 2025, beating all previous records of public engagement on regulations.gov.

The system is supposed to log every individual comment into the docket and it appears that we tripped some circuit breakers. At the time of this writing, about 3,480 comments have been reviewed and posted publicly. If the government takes the same time to process the rest of the comments received, it will take about 3 years to review and post all the comments from public!

In this podcast we are ranging into some broader discussion, such as “what is biologics” (a Pandora’s box of a question) and much more. Please don’t miss this video!

CHD’s citizen petition is just the first step to force FDA to remove the fraudulent BLA approval from the Covid-19 shots and revert them back to the status of EUA authorized products. But, wait, that EUA no longer exists! It was removed in August 2025. Well, then these toxic shots that have caused so much carnage will finally have to be removed from the market, right?

Unless HSS secretary RFK decides to put them back under the EUA for the duration of the PREP Act declaration for covid, which has been extended to December 31, 2029 by his predecessor, and which he refuses to terminate or even publicly mention, for no apparent good reason. Let’s see what happens!

CHAPTERS

0:00:05 CHD’s Citizen Petition To Revoke Pfizer And Moderna BLAs

0:05:07 Public Response And Record Comment Numbers

0:11:06 What Are Biologics? Basic FDA Categories

0:15:18 From Traditional Biologics To mRNA “Biologics”

0:21:52 NDA vs BLA And Biologics Carve‑outs

0:27:49 Biologics, Vaccines, And Industry Incentives

0:31:19 Growth Of Biologic Drugs And Vaccine Focus

0:31:41 EUA Timeline And 2021 BLA Approvals

0:33:45 Comirnaty Rollout In US vs Europe And Relabeling Claims

0:36:15 Confusion Among Public And Doctors About EUA vs BLA

0:37:28 FOIA Delays And EUA vs EAU Confusion

0:39:40 EUA As Countermeasure Outside Normal FDA Rules

0:43:42 Sewage vs Drinking Water Analogy For EUA vs BLA

RESOURCES

* CHD’s Citizen Petition

* Tell the FDA to Revoke Licenses on COVID Vaccines

* Sasha Latypova Breaking: Citizen Petition to the FDA filed by Children’s Health Defense with my input.

* Biologics License Applications (BLA) Process (CBER)

Art for today: Fury, watercolor on paper, 7x11 in.

Please support Leslie and HFDF by following this link.

[Ketchum, ID] – On December 23, 2025, Health Freedom Defense Fund (HFDF), California Educators for Medical Freedom (CAEMF), and several individual plaintiffs petitioned the United States Supreme Court (SCOTUS) to review a case that raises one of the most consequential constitutional questions of our time: Do Americans possess the fundamental right to refuse unwanted medical treatment, even during a public health crisis?

A sweeping decision by the Ninth Circuit Court of Appeals dangerously ignores more than a century of Supreme Court jurisprudence and effectively strips courts of their duty to protect individual liberty. The ruling allows governments to impose mandatory medical interventions without meaningful judicial review, so long as officials invoke “public health.”

“For generations, Americans have relied on courts to balance public health needs with personal freedom,” said Scott Street, counsel for the plaintiffs. “The Ninth Circuit abandoned that balance, granting government officials virtually unchecked power over individuals’ bodies so long as they cite public health and say there is an emergency, regardless of the efficacy of their orders.”

When the Ninth Circuit cited Jacobson v. Massachusetts, a 1905 Supreme Court case involving smallpox vaccinations, it not only misconstrued Jacobson, it ignored how constitutional law has evolved over the past 120 years.

Contrary to the Ninth Circuit’s claim, Jacobson did not give governments unlimited authority to mandate medical treatment without evidence or accountability. Instead, as later Supreme Court decisions made clear, Jacobson applied a balancing test—weighing an individual’s liberty interest against the government’s actual, demonstrated need to protect public health.

That balancing approach was reaffirmed repeatedly throughout the twentieth century in cases such as Cruzan v. Director, Missouri Department of Health, where the Supreme Court explicitly recognized a person’s constitutional right to refuse unwanted medical treatment. Courts across the country, including the Ninth Circuit itself in earlier decisions, consistently described Jacobson as a case that balanced liberty and state interests—not one that eliminated judicial scrutiny altogether. Yet during the Covid-19 pandemic, the Ninth Circuit and other circuit courts, turned a blind eye to this precedent.

The Ninth Circuit held that due to a legal principle known as rational basis review, judges don’t need to consider whether a mandated medical intervention actually prevents disease as long as the government policy is rational. According to the ruling, as long as politicians and executive officials could have believed a medical intervention serves public health, the courts need not become involved.

The plaintiffs warn this reasoning is unprecedented—and dangerous.

Under the Ninth Circuit’s framework, courts must accept the government’s assertions at face value and may not require evidence, justification, or even minimal proof. Plaintiffs assert that this standard allows judges to imagine hypothetical reasons for a policy, even if those reasons are unsupported by facts.

The plaintiffs argue this standard has no place when fundamental rights such as the right to direct one’s own medical care are at stake.

“Bodily autonomy is the most basic of human rights and the government should only override that liberty when an individual poses a threat to themselves or others, but the Ninth Circuit held that government may trample this sacred right without evidence or judicial oversight,” said HFDF president, Leslie Manookian.

The implications extend far beyond vaccines. As the dissenting judges in the Ninth Circuit warned, if the government can mandate medical treatments simply because officials believe they might reduce symptoms, there is no clear limit to what could be compelled.

Today it may be one type of injection. Tomorrow, it could be forced medication, invasive procedures, or other treatments imposed against a person’s will—all justified in the name of public health, with no opportunity for citizens to challenge the government in court.

The plaintiffs are urging the Supreme Court to grant review because only the nation’s highest court can resolve the glaring conflict over how Jacobson should be understood today.

The Supreme Court now faces a clear choice:

* Reaffirm that Americans retain the right to bodily autonomy, protected by meaningful judicial review; or

* Allow an outdated and distorted reading of Jacobson to become a permanent justification for unchecked government power.

“This case is not just about the Covid crisis,” said Manookian. “It’s about the future of liberty in America.”

To read the Petition for a Writ of Certiorari and more background on the case click here.

Art for today: At the Ranch, oil on panel, 9x12 in.

Reminder: If you have not already done so, please read CHD’s Citizen Petition to revoke BLA licensure for the covid shots and submit a comment. You can write up to 5000 words and attach up to 200 mb of documents. You can tell the story of your injury or loss of job due to illegal mandates, or express what you think about the global agenda of depopulation, and discuss anything else you may feel relevant. This is an opportunity for the public to make themselves heard. There are already 102K+ comments submitted, beating every historical record on Regulations dot gov, which is awesome, but we need more! Some people report system error, or not taking a comment. This may be because so many people are commenting simultaneously and we are tripping the circuit breakers. If that happens wait a bit and come back. CHD reserves the right to sue HHS if this petition is not address within 180 days.

Our Citizen Petition is based in part on the Moderna FOIAed documentation addressed in this video talking with RFK Jr before he joined Trump admin and became the head of HHS. The discission in this video happened in 2022. As a backdrop, I was asked to review Moderna’s Nonclinical data package (toxicology studies in animals) produced in response to the Judicial Watch’s FOIA and a lawsuit.

Download this document if you have the stomach to read 700+ pages of total b******t:

JW did the work, obtained the documents and then sat on this package for months after it was produced, without publishing a story. The journalist who asked me to comment did not ask me to keep anything confidential. As a courtesy to him and JW, I waited for months, hoping they will publish. They did not. When the FDA (Peter Marks and Janet Woodcock) “approved” this poison shot for children, and started a public campaign of “safe and effective” for kids, that became the red line for me. I published the findings of fetal abnormalities (malformed ribs) in the rat reproductive toxicity study included in this package, as well as the overall horrific fraud, as I discuss it in the video with RFK Jr. The JW journalist got in trouble with his bosses for this, however, he thanked me for going public afterwards, and for pushing his editors to publish this information.

Related article:

As I discuss in the video and in affidavit above, Moderna did not fulfill even minimal standards for BLA licensure. Moderna nonclinical studies amount to claiming their apple juice is organic by testing random bananas. As an example, I pulled these screenshots from the files to illustrate the deception they pulled off (as we discuss in CHD Citizen Petition, it is fraud under BLA, but fully legal under EUA):

Art for today: Two Persimmons, oil on panel, 9x12 in. I have a 5 ft persimmon tree, and this year it produced an incredible amount of fruit. No idea what to do with them, but for now they make good subjects for still lives.

This video is for some reason not well synced with audio. You can watch this segment on Rumble here (starts around 35 min).

Reminder - if you have not submitted a comment to the CHD Petition to revoke BLA licensure from Pfizer and Moderna covid shots, please do so here. As of yesterday, we had 100,953 comments! The counters was not updated for some reason since then. I wonder why. Did we crash Regulations.gov?

Art for today: Persimmons and a Buddhist Monk, oil on panel, 12x16 in.

Readers, you have exceeded all my expectations - as of this morning our Petition gained 100,953 comments! The number is likely much larger since there is a delay in the count as the comments are getting reviewed before posting:

My jaw is on the floor. I am humbled by the powerful support we are seeing, and thank every one of you who wrote a comment. Please continue sharing and writing comments. Let’s get to a million comments, shall we? We need to tell the leadership at the FDA/HHS that this issue will haunt them.

This post is a 30 min video interview where Ray Flores (CHD outside counsel) and I are discussing our new Citizen Petition submitted to the FDA on December 8 with Kim Mac Rosenberg (CHD atty).

If you haven’t read the petition yet, you can find it here, links to the document and how to comment also explained in this post:

Art for today: A Single Bloom, oil on linen, 8x10 in.

Small edit: I misspoke, Brianne Dressen was offered $1200, not $3000 by AstraZeneca as compensation for her permanent disability.

This is a recording from my discussion with Shannon Joy on Tuesday, November 18. We talked about:

-MAHA Summit being headlined by Regeneron Pharma and CRISPR Therapeutics

We talked about this horror show a bit:

-Bryan Johnson overdoses on mushrooms, takes a million pills a day and sucks his son’s blood and claims he “reduced his epigenetic age”…. uh… let me laugh hysterically for 30 seconds…. ok I am back. This health bro clown also has “long covid” apparently:

Jim O’Neill wants us to expect brain chips and “more of this”? Right. That’s what MAHA is all about now…

-We talked about CRISPR and Baby KJ story, which I published here.

-We talked about the military operation and the hierarchy of the covid crime cartel.

- I referred to my previous research about Agent Orange and lessons learned from it.

-What is and isn’t “willful misconduct”?

-MAHA deflections from vaccines.

-BARDA’s global Octopus and why I want Stephen Hatfill to discuss it.

-PREP Act’s unconstitutionality and the phone call from RFK Jr I received in May.

On this last point, seeing a clip of this discussion, Kevin McKernan got his panties in a real tight twist and wanted Jikky and Moussad agents to help him cope emotionally…

Jessica Rose said she is doing a “deep dive” into my phone records… I suppose, as an Israeli she might have the proper connections to do that. I asked her how exactly she was deep diving and into what, but she has not responded…

Ok, that was awesomely fun!

Readers, enjoy your weekend. I am certainly planning to do so.

Art for today: a little plain air piece I did in about 30 min while the sun was setting behind the mountains. Silverado/Deerpark cross, looking at Marham Vineyards. oil, 12x12 in.

Update: I added download of the slides for paid subscribers. Scroll past the artwork at the end of this post.

This is the video recording from my presentation in Utah last month. It was great to meet some of my readers in person. I appreciate you saying hi :)

If you were not able to be in Utah, please don’t miss this recording, and please share.

This is a message from Weston A. Price Foundation. Please consider becoming a member and support their great work:

The conference recordings are found here: https://www.fleetwoodonsite.com/wise/2025/stream

We will also make a few talks available for free. We hope you will share the conference information with others.

Save the date for our 26th annual conference! Omni Shoreham Hotel in Washington, DC, October 16-18, 2026.

Please help the Weston A. Price Foundation restore nutrient-dense foods to the human diet through education, research and activism. westonaprice.org

Art for today: Postcard from Utah, watercolor, 6x8 in. I never leave home without my watercolor set. I drove to Utah for this conference and stopped around UT/NV border to make this little painting.

Link to the powerpoint slides for paid subscribers:

Rumble link here

I removed commercials but included the section of the show which followed mine - Dr. Chloe Carmichael discussing the case of the transgender mass shooter in Minnesota. I think this is a very interesting discussion and I encourage you to listen.

Relevant posts discussed in this episode:

Art for today: Yountville Cross, watercolor, 9x12 in. Available art here.

Liz Gunn is a journalist from New Zealand and Jim Ferguson is a journalist from the UK. The detailed information about this interview can be found on FreeNZ Substack. Please subscribe and follow them!

In the first half of the interview we are discussing the ongoing case in the Netherlands against the government officials, Bourla, Gates and Schwab, alleging democide and use of bio-chemical weapons in the global military operation “Covid”. Other topics discussed in the interview are the motives that drive the governments to attack the people, and psychological methods deployed. Many other items are covered.

Art for today: Plum Harvest, oil on panel, 12x16 in. Available art here.

This interview is a digest and a discussion based on my recently published articles. If you have not had the time to read everything I published in the past week, this is a place to start.

Related materials:

Art for today: Summer bounty, oil on panel, 9x12 in. Available art here.