What Is the PREP Act?

An Essay on the Fifteen-Minute Memo That Would End the Emergency

A single administrative memo to the Federal Register, signed by one person and delivered in about fifteen minutes, would end the COVID-19 PREP Act emergency declaration. The Secretary of Health and Human Services holds that authority under the statute.¹ It has been available to Robert F. Kennedy Jr. since he took office in February 2025. It has not been used.

This essay is about what that unused authority reveals.

The Reporting

The account of Kennedy’s refusal comes from Sasha Latypova, a former pharmaceutical executive with twenty-five years managing clinical research and regulatory programs for companies including Pfizer, Johnson & Johnson, AstraZeneca, and GSK. Since 2021 she has focused on the legal and regulatory architecture of the 2020–2023 government pharmaceutical operation. With Debbie Lerman she compiled the COVID Dossier, a document set profiling how parallel structural mechanisms were implemented across dozens of national jurisdictions.²

Latypova had direct access to Kennedy before he took office. She appeared on his podcast twice, spoke with him by phone, and has video recordings from 2023 in which they discussed the government operation as a Department of Defense–coordinated campaign running under the PREP Act framework. She describes him at that time as in “full agreement and full understanding.” On July 8, 2026, she recounted her subsequent conversations with him after he became Secretary. What follows draws on that account and on the underlying statutory and Federal Register record.

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The Architecture

Once a PREP Act emergency declaration is in force, a class of products called “covered countermeasures” becomes eligible for a set of legal and financial arrangements that do not apply to ordinary pharmaceuticals. Understanding these arrangements is the key to understanding why the declaration remains in force.

The liability regime is the foundational layer. Under 42 U.S.C. § 247d-6d(a)(1), manufacturers, distributors, program planners, and qualified persons who administer covered countermeasures are shielded from “all claims for loss” arising from administration or use of those countermeasures. A single narrow exception exists for “willful misconduct,” defined so restrictively in the statute that it functions as near-absolute immunity.³ Ordinary product liability does not apply. State tort law is preempted. Injured parties cannot sue the manufacturer. They cannot sue the administrator. Their only remedy is the Countermeasures Injury Compensation Program, an administrative process outside the tort system entirely. The regime is not a compromise between liability and protection. It is liability removed.

The procurement pathway is the second structural layer, and it is where the architecture reveals its true purpose. Covered countermeasures purchased under Operation Warp Speed were not acquired through ordinary pharmaceutical contracting. They were purchased through “Other Transaction Authority” contracts administered by the Department of Defense, specifically by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, with Advanced Technology International as prime contractor. Legal researcher Katherine Watt has traced the specific contract vehicles and their statutory basis in detail.⁴ These are not commercial purchase agreements. OTA contracts are the mechanism traditionally used for prototype and demonstration of defense materiel. They operate outside the Federal Acquisition Regulation. They are the procurement architecture the military uses when it needs to move fast and bypass civilian commercial law.

The declarations themselves activate this regime. Under 42 U.S.C. § 247d-6d, the Secretary need only “determine that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency.”¹ No data are required. No showing of active illness. No cost analysis. No geographic specification. The determination rests on the Secretary’s stated belief. Congress may amend the PREP Act. Only the Secretary can rescind a declaration.¹ The authority is unilateral and unreviewable.

Once invoked, the declaration keeps the countermeasure regime live. The products retain immunity. The procurement pathway remains available. The military contracting authority continues to flow. The regime persists for as long as the declaration remains in force.

The Court Record

The Department of Defense contracting is not inference from documents. It has been confirmed on the record in federal court.

In April 2022, in whistleblower Brook Jackson’s False Claims Act case against Pfizer, the company moved to dismiss on the grounds that its product was not a vaccine but a Department of Defense prototype, and that Pfizer therefore had no obligation to conduct valid clinical trials or demonstrate safety and efficacy. On October 4, 2022, the United States government filed a Statement of Interest supporting the motion to dismiss, confirming that clinical trials were “never material or necessary” for DoD to pay contractors for producing and distributing the products.⁵ The government’s own filing established, in litigation, what the procurement architecture already implied. The product was a prototype defense article, not a regulated pharmaceutical. The public health framing was legal cover.

A product purchased through military procurement channels, regulated under military contracting rules, protected by military-grade liability immunity, deployed through a declaration that vests unilateral termination authority in a single executive, and defended in federal court by the United States government as a defense prototype rather than a pharmaceutical, is not a pharmaceutical product under civilian regulatory control. It is a defense article deployed under a public health cover story.

Latypova’s characterization of “countermeasure” as a euphemism for weapon is not rhetoric. It is description of the legal and procurement architecture. The products are purchased as weapons are purchased. They are regulated as weapons are regulated. They carry the immunity that weapons carry. The United States government has said so in a federal court filing.

The Ten Declarations

Ten PREP Act emergency declarations are currently in force. Their extension dates run from 2027 through 2032. The declarations use the terminology supplied by the statute: COVID-19 (extended through December 2029), pandemic influenza, anthrax, smallpox, botulinum toxin, Ebola, Marburg, nerve agents and insecticides used against the U.S. population, and acute radiation syndrome. Kennedy issued an additional declaration during his tenure invoking hantavirus, initially set to expire in July 2026.⁶

Each declaration activates the regime described above. Each protects a different class of countermeasures from liability. Each sustains the military procurement pathway for products under that emergency designation. Read as a group, these ten declarations sustain a permanent emergency framework. The COVID-19 declaration extends nearly four years into the future by administrative choice. The smallpox declaration runs to 2032. The framework is built to persist across administrations because no single Secretary, acting alone, has terminated an active PREP Act countermeasure declaration since the statute was enacted. It survives because the architecture is designed to survive.

The Kennedy Moment

Latypova supported Kennedy during his presidential campaign. She withdrew that support based on specific events and statements, not personality or partisan drift.

In recorded 2023 conversations, Kennedy agreed that the 2020–2023 operation was a military campaign coordinated through the PREP Act framework, that the declarations sustained the countermeasure regime, and that ending the COVID-19 declaration would be a foundational act of accountability. His authority as future HHS Secretary was explicit in those discussions.

She then watched the “Make America Healthy Again” movement take shape. The initial MAHA policy statement, published in the Wall Street Journal in September 2024, omitted any mention of vaccines. Subsequent policy documents focused on food dyes, seed oils, sugar, and glyphosate, everything but the declarations that were keeping the countermeasure regime in force.

She extended goodwill through the transition and into Kennedy’s first months as Secretary. Then she asked him directly, by phone, to rescind the COVID-19 PREP Act declaration. In May 2025, Kennedy told her he knew what she was asking, but that Trump would not let him do it. She raised the question again in a later conversation.

He told her to sue him.

What the Refusal Means

In that moment, the door closed.

Latypova had not asked for a policy change requiring Congress. She had not asked for legislative repeal. She had asked the Secretary to exercise an authority that was entirely his to exercise: a fifteen-minute memo to the Federal Register, ending the emergency declaration, terminating the regime. The authority existed. The Secretary understood it existed. He declined to use it.

The question that follows is not whether Kennedy has failed to live up to the health-freedom movement’s expectations. The question is what his refusal reveals about who actually holds power over this regime.

Several possibilities sit on the table without resolution. Kennedy may have calculated that the regime serves strategic purposes he wants to preserve. He may face pressures from other executive branches that prevent him from acting, as he claimed in the May 2025 call. He may believe the declarations can be addressed through other means, at other times, and that rescinding them now would invite political cost he is unwilling to bear. He may lack the will to act even though he has the authority. He may have never intended to act, and the campaign promise was a performance for an audience that believed him.

But this much is certain: no HHS Secretary in either party has terminated a live PREP Act countermeasure declaration since the statute was enacted in 2005. The regime has survived four administrations. It has survived political transitions. It has survived a challenger who promised to end it. It persists because the architecture was built to persist, built with bipartisan cover, designed to resist termination, sustained by the choice of every official who has held the authority to end it.

Kennedy was not the first to make that choice. He may not be the last. But his refusal confirms what the continuity already suggested: the regime is not vulnerable to a change of administration. It is structural.

Dismantling something structural requires mechanisms that do not depend on who holds the office. One such mechanism is now running.

The Petition

In December 2025, Latypova co-authored a Citizens Petition to the FDA with Children’s Health Defense, asking the agency to revoke the Biologics License Applications issued for the mRNA COVID-19 products in 2021. The petition documents in detail the manufacturing fraud identified in the November 2020 leak of European Medicines Agency records, including the three Quality Major Objections raised by EMA reviewers regarding cGMP non-compliance, mRNA instability, and gaps in the manufacturing documentation that made compliance verification impossible. The petition argues that the products never met the legal standards for BLA licensing and that the FDA’s decision to grant those licenses in 2021 was regulatory fraud legally shielded by the PREP Act framework.⁷

The petition drew over one hundred thousand individual public comments in a single day, breaking historical engagement records for FDA citizen petitions. The FDA has 180 days to respond. If it declines to act, the petition converts into legal grounds for a lawsuit against HHS. That inflection point falls in June 2026.

The petition does not depend on the Secretary signing the memo. It tests whether the FDA will confront the regulatory fraud embedded in the current BLA licenses on its own, and failing that, whether the courts will compel it to.

The Origins

The PREP Act was inserted into the 2006 Emergency Supplemental Appropriations Act, the Katrina relief bill.⁸ It received no committee hearing in the form ultimately enacted. In December 2005, Senators Hillary Clinton, Joseph Biden, Ted Kennedy, and Robert Byrd rose to object, characterizing the provision as a substantive rewriting of tort law that stripped citizens of the right to seek judicial remedy for injuries caused by government action. Then they supplied the votes to pass it.⁸

This is the pattern that built the regime: opposition entered on the record, bipartisan cover supplied, architecture embedded, and the framework left in place for every subsequent administration to inherit and sustain.

The Memo

The memo would take fifteen minutes to draft. It would take another fifteen for the Office of the Assistant Secretary for Preparedness and Response to process it. It would publish in the Federal Register the same day.

It has been available since February 13, 2025. It has not been drafted. On the day this essay publishes, it will not have been drafted. Between now and December 2029, whichever Secretary holds the office will choose, on each of those days, not to draft it.

The petition may prevail. The courts may compel action. The declaration may expire on its own timeline. None of that changes what the memo is: the direct authority to end the emergency, held by one person, unused every day it is not signed.

That daily choice, made in silence by whoever holds the authority, is the regime. It has been the regime since 2005. It will be the regime for as long as no one signs.

Fifteen minutes.

How to Explain the PREP Act to a Six-Year-Old

There’s a rule. If a company makes something that hurts you, they have to say sorry and pay you back.

The rule is good. It stops companies from making things that hurt people on purpose.

But a long time ago, some grown-ups made a different rule. The different rule says: if the government says there’s an emergency, the good rule stops working. During an emergency, companies can make things that hurt people, and nobody has to say sorry, and nobody has to pay you back.

Only one grown-up gets to decide when there’s an emergency. He’s called the Secretary of Health.

Right now the Secretary of Health says there is an emergency. He has been saying this for six years. He doesn’t have to show anyone why. He doesn’t have to prove that anyone is sick. He just says the word, and companies get to skip the good rule.

If he wanted to, he could stop the emergency. He would write a short note. Then the good rule would come back. Writing the note would take fifteen minutes.

He said he would write the note. He promised, before he became Secretary. Everyone who voted for him believed him.

Then he became Secretary. Someone asked him to write the note. He said no.

The good rule is still turned off. Companies are still making things that hurt people. Nobody has to say sorry. Nobody has to pay you back.

That’s the PREP Act.

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References

1. Public Readiness and Emergency Preparedness Act, 42 U.S.C. § 247d-6d, § 247d-6e. Enacted as part of Public Law 109-148, Division C (December 30, 2005).

2. Sasha Latypova and Debbie Lerman, “The COVID Dossier,” published on Latypova’s Substack, “Due Diligence and Art,” documenting the parallel regulatory and procurement structures across national jurisdictions. Interview drawn from VSRF Live #235, “The Architecture of Control,” hosted by Steve Kirsch and Livio Sanchez on VSRF Media, streamed July 8, 2026.

3. 42 U.S.C. § 247d-6d(c) and (d), defining “willful misconduct” and establishing the exclusive federal cause of action.

4. Department of Defense, Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense; Advanced Technology International. Contract documentation and analysis by Katherine Watt on the PREP Act, public health emergency law, and Emergency Use Authorization procurement architecture. Watt’s summary document is available at the Bailiwick News Archives.

5. United States ex rel. Jackson v. Ventavia Research Group, LLC, Pfizer, Inc., et al., No. 1:21-cv-00008 (E.D. Tex.). Pfizer’s Motion to Dismiss filed April 2022; United States Statement of Interest filed October 4, 2022. The government’s filing confirms that clinical trial performance was not material to Pfizer’s contractual obligations for the Department of Defense.

6. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, “PREP Act Declarations and Amendments,” listing active declarations. Available at aspr.hhs.gov. Most recent amendment to the COVID-19 declaration available at the Federal Register.

7. Citizens Petition to the U.S. Food and Drug Administration to revoke Biologics License Applications for COVID-19 mRNA vaccines, Docket No. FDA-2025-P-6831-0001, submitted December 2025 by Sasha Latypova and Children’s Health Defense. Available at regulations.gov. The petition incorporates analysis of the November 2020 European Medicines Agency document leak and the manufacturing compliance failures identified by EMA reviewers prior to the initial vaccine launches.

8. Public Law 109-148, “Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006,” signed December 30, 2005. Congressional Record, Senate, December 2005, floor remarks on the pandemic influenza liability provisions. U.S. Senate and House roll-call votes on H.R. 2863, December 2005.