PREP Act Reform
Before it is too late
This article is going to get technical. It is being written so that vaccine reform advocates can understand the PREP Act, and regulators, government leaders, and public health officials who might wish to reform the public health endeavor regarding pandemic preparedness and responses can better understand the issues. In this article, I am putting my public health and clinical trials developer hat on. So, hang on - even if this article is technical, it is vital for the future direction of this country.
What is the PREP Act?
The Public Readiness and Emergency Preparedness Act (PREP Act) is a U.S. federal law passed in 2005. It allows the Secretary of the Department of Health and Human Services (HHS) to issue declarations that provide broad immunity from liability for developing, manufacturing, distributing, administering, and using medical countermeasures during public health emergencies. The goal of the law is to encourage a quick response to health threats like pandemics or bioterrorism by reducing the risk of lawsuits for those involved in creating and deploying critical medical countermeasure products.
The PREP Act was passed in response to concerns that fear of lawsuits was discouraging pharmaceutical companies from developing vaccines and other critical medical products for emergencies. Another action taken to entice big Pharma was the notorious “Other Transactional Authority” (OTA) process that functionally bypasses the Federal Acquisition Regulations. OTA was used extensively during the federal COVID response, including for the development and acquisition of the mRNA countermeasure products.
At least one aspect of the PREP Act was designed by big pharma to bypass critical FDA pre-licensure infrastructure.
The PREP Act is what has allowed the US government to pay out almost nothing in damages to people injured from the COVID-19 vaccines.
However, COVID-19 vaccine injuries are not eligible for compensation under the National Vaccine Injury Compensation Program (VICP). Instead, these injuries are handled by the Countermeasures Injury Compensation Program (CICP), which offers less transparency, lower compensation, and no right to appeal.
The average payout for the CICP is about $4,000. Only three percent of the claims have been approved; the rest have been denied. The CICP has made a single large payout for a death attributed to a COVID-19 vaccine injury of $2.5 million for a case involving thrombosis with thrombocytopenia syndrome (TTS).
In comparison, the National Vaccine Injury Compensation Program (VICP) has paid 5.2 billion since 1988 in vaccine injury compensation. Over the past two decades, annual compensation has generally ranged from approximately $75 million to over $250 million per year. More recently, those numbers range from about 200-250 per year. These are most recent numbers available:
This means that the CICP claims were paid out at $4,000 per individual, while the VICP program paid out (on average) $450,000 per vaccine claim. THAT IS A 112.5 fold difference between the two programs! This is a strong indicator of systemic bias in the CICP program.
The budget for PREP Act payouts for vaccine injury, specifically through the Countermeasures Injury Compensation Program (CICP), is determined by the United States Congress. Not the executive branch. Congress appropriates funds from general tax revenue into a dedicated account called the Covered Countermeasure Process Fund (CCPF), which is used to pay eligible claims for injuries or deaths caused by covered countermeasures like COVID-19 vaccines. Note - although vaccines are being used as an example, the CCPF would also cover other experimental drugs used as a countermeasure such as Remdesivir and the various monoclonal antibody preparations.
The PREP Act grants pharmaceutical companies (and other "covered persons") immunity from nearly all lawsuits related to EUA-authorized countermeasures, including experimental drugs. This changes the very nature of drug development in the countermeasure space.
The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), administers the program and makes decisions about individual compensation claims, but it is Congress that sets and adjusts the overall funding for the program.
The CICP has been widely criticized for its appearance of bias, lack of transparency and strict eligibility requirements.
Public Readiness and Emergency Preparedness (PREP) Act Declaration for COVID-19 Countermeasures
The PREP Act has been used twice, once for the H5N1 influenza virus response in 2009 and then for the SARS-CoV-2 virus response.
Injuries from FDA-approved COVID-19 vaccine formulations (e.g., Moderna’s Spikevax and Pfizer’s Comirnaty for ages 12+) remain minimally covered by the Countermeasures Injury Compensation Program (CICP) rather than the National Vaccine Injury Compensation Program (VICP). This is due to the ongoing Public Readiness and Emergency Preparedness (PREP) Act Declaration for COVID-19, which remained in effect through December 2024 and has been amended multiple times.
The Public Readiness and Emergency Preparedness (PREP) Act Declaration for COVID-19 medical countermeasures is set to expire at the end of 2029. The U.S. Department of Health and Human Services (HHS) under Biden extended the declaration to maintain liability immunity and certain authorities for the manufacture, distribution, administration, and use of COVID-19 vaccines, treatments, and tests.
The Secretary of HHS can amend, extend, or terminate a PREP Act Declaration at any time based on their assessment of public health needs and other relevant factors. All the HHS Secretary needs to do is determine that the circumstances justifying the Declaration no longer exist or that it is otherwise appropriate to terminate the Declaration. The Secretary can formally revoke or shorten the duration of the Declaration before its currently scheduled expiration date.
HHS Secretary Kennedy must end The Public Readiness and Emergency Preparedness (PREP) Act Declaration for COVID-19 as soon as possible.
The Malone Institute compiled a list of almost 800 peer-reviewed articles on adverse events from the mRNA COVID-19 vaccine in 2023. The AI CHAT-GP3 has reviewed this list and writes that “This document is a legitimate, peer-reviewed reference list, and can be used as a resource for identifying published scientific literature on COVID-19 vaccine adverse events.” There are other similar lists out there showing the extensive harms of these vaccines.
Although Secretary Kennedy is using AI to sort through the reams of government data to show significant harms from this vaccine, to counteract the lies and data obfuscation of the CDC that goes back years (as even documented by the New York Times), the evidence is clear and compelling in the peer-reviewed literature. These vaccines are not safe, are not effective, do not stop transmission of the virus, do not prevent disease or death, and do not meet the regulatory criteria under which they were authorized.
If the PREP Act Declaration for COVID-19 countermeasures were ended by the Secretary of Health and Human Services (HHS), COVID-19 vaccine injuries would no longer automatically be covered by the National Vaccine Injury Compensation Program (VICP).
This would mean two things: those injured by these vaccines could sue the vaccine companies for liability going forward. This means that it would be easier to sue physicians, vaccine clinics, such as CVS or Walmart, and pharmacists who administer such products.
However, those injured would not be eligible for payment under the National Vaccine Injury Compensation Program (VICP) either - unless the CDC recommended these vaccines for routine administration to children or pregnant women be added to this table within two years, and Congress allocates a tax on these vaccines to cover costs.
This is why Secretary Kennedy’s statement is so important:
Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from CDC recommended immunization schedule. Bottom line: it’s common sense and it’s good science. We are now one step closer to realizing POTUS’s promise to Make America Healthy Again.
-HHS Secretary Kennedy
In effect, Secretary Kennedy started the process of pulling the plug on these vaccines as long as he also terminates the PREP Act Declaration for COVID-19 vaccines.
Without liability protections, no company will continue manufacturing or selling these products in the USA.
The pressure by pharms and the healthcare industry for Congress to step in will be enormous. Congress would be extensively lobbied - with millions of dollars placed into the coffers of Congressmen to place the mRNA into VICP program. HHS Secretary Kennedy and President Trump must resist these lobbying efforts.
It was President Trump who first invoked the Prep Act for COVID-19. So, to think that he has learned his lesson and wouldn’t invoke it again is wishful thinking. Then 2028 looms large, there is no guarantee that VP Vance will become president of the United States.
The PREP Act is a law passed by Congress. Only they can enact the permanent reform necessary. Therefore, the PREP Act can not be revoked by HHS Secretary Kennedy, FDA Commissioner Makary, or even by President Trump.
Secretary Kennedy has been in office just short of four months. The FDA Commissioner has been in office for two months. They were targeted by Senators specifically regarding vaccines. Kennedy made the following promises to Senator Cassidy during his confirmation:
Meet or speak with Cassidy multiple times a month and seek his input.
Allow Cassidy input into hiring decisions at HHS beyond Senate-approved positions.
Work within the current vaccine approval and safety monitoring systems.
Maintain the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices’ recommendations (ACIP) without changes.
Promise that the CDC will not remove statements on its website pointing out that vaccines do not cause autism.
Not use “subversive techniques” to change policies enacted by Congress without first going through Congress.
Thinking that HHS Sec. Kennedy, who is a Federal government employee, could overturn a law passed by Congress is naive. For groups of advocates to insist upon this is dangerous. He has been tasked to work within the Federal system of laws, rules, and regulations. If he doesn’t, he could be terminated or held accountable by Congress. There would immediately be lawsuits brought, and his efforts to reform the system would end.
But Sec. Kennedy has enormous latitude on what he can do. He can end the PREP act declaration for COVID-19 countermeasures. He can reconstitute the CDC Advisory Committee on Immunization Practices (ACIP) - as current law allows him to do.
He can also make significant changes to the Countermeasures Injury Compensation Program. These are the changes that he is allowed to make under the current laws.
So, there are many steps that HHS Secretary Kennedy can do. My intelligence sources indicate that he is doing what he can and is working on many of these (caveat: I don’t have any intelligence into the inner workings of the CICP program). But rest assured, changes are coming fast. The strategy that he has laid out is working; but it will take time - that is the nature of working for the federal government.
HHS Secretary Kennedy can change the leadership, staffing, and some administrative aspects of the CICP board and panels and propose new rules (such as revamping injury tables). However, major reforms, such as making the board truly independent, relocating the program, or allowing court appeals, would require an act of Congress.
Of note, the names of the individuals serving on the Countermeasures Injury Compensation Program (CICP) “board” or administrative panels are not publicly available. However, Commander George Reed Grimes has been Director of the Division of Injury Compensation Programs at HRSA since 2021. As the director, he oversees the National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP). There is no information that the Trump administration has removed him from this position, but this seems like another good place to start. We can be certain that he did what the Biden administration instructed him to do regarding compensation, but that doesn’t make it right.
However, in the end, permanent reform of the PREP Act must come from Congress.
All it will take for this to happen all over again is enough fear-mongering by the WHO, fake news media, and big pharma to cause scientists who profit from modeling pandemic fear to drive the public, public health officials, and the President into another frenzied state of fear, thereby declaring another PREP Act Declaration emergency. Rinse and repeat; the cycle will start all over again.
There is now a window during which the fearporn about “the next” pandemic that will wipe out some percent of humanity and life as we know it is minimal. Now is the time for Congressional reform of the PREP Act. However, getting such reform out of a Congressional committee will be nearly impossible. Therefore, this legislation may need to be included in other bills - this strategy for navigating a particularly challenging committee is known as a “trojan horse.”
Without that, rest assured, what we experienced with H1N1 in 2009 and SARS-CoV-2 from 2020 to the present will happen again and again.
Postscript:
A note on why one can never trust CHAT-GP3 or any AI for that matter.
I asked Perplexity AI (CHAT-GP3 based) to find the article by the New York Times documenting that the CDC was hiding COVID-19 data.
The AI responded immediately that the New York Times never wrote such an article, but as I wrote about this in 2022 and spoken about it many times, I knew that the AI answer was cow manure.
The dialog is below:
I then found the article and accused the AI of lying.
It then pretty admitted that it lied and that the New York Times did write such an article.
This is how the AIs and those that control them are re-writing history. There is no government regulation, no repository of alternate website and media, just the AI version condensing the Internet into acceptable truths that future generations can digest.
In twenty years from now, our present will be wiped from memory and the Wiki/AI version of events will be all that is left of what has happened.
There will be the rare academic, who digs out the old books that document what has happened.
Reforming the Internet and AIs - is a critical step in maintaining human history and ensuring that this never happens again.
How this can be done is beyond the scope of this article - but it must be done.