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Class 1 recalls must be supported as completely as possible by scientific documentation and statements that the conclusion is the opinion of the individual(s) making the health hazard determination.

UPDATED: I posted the wrong time in my last message. The correct time is 7:00 - 9:00 PM Eastern/ 4:00 -6:00 PM Pacific.

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October 10, 2025: If you’re interested in the most recent MAHA updates or have any questions you’d like to ask me directly, please join Matt Youngblood and I on X tonight from 4:00 - 6:00 pm Pacific/7:00 - 9:00 pm Eastern.

Here’s the link: https://x.com/i/spaces/1OyKAjkjQLzGb

We’ll also discuss:

Is HHS Pursuing a Class 1 Recall?

Class 1 recalls must be supported as completely as possible by scientific documentation and statements that the conclusion is the opinion of the individual(s) making the health hazard determination. - FDA - Code of Federal Regulations - 21 CFR § 7.41

Copyright © 2025 Karen Kingston – All Rights Reserved.

The following content is part of the med-legal analysis I submitted to the FDA on May 19, 2025 and presented live on May 22, 2025.

NCVIA Provides Legal Basis to Issue a Class 1 Recall Based on Fraud

Under the National Childhood Vaccine Injury Act of 1986, specifically §300aa–27(a)(1)(2), vaccines introduced after December 1987 are legally required to result in fewer and less serious adverse reactions than those available on the market at that time.

In a shocking admission, the US government filed an appellate brief in the Brook Jackson case vs Pfizer, asserting, “The FDA was aware of the protocol violations allegedly witnessed by relator before it granted Pfizer emergency use authorization for its vaccine.”

Not disclosing protocol violations to the public, specifically if the violations covered up serious adverse events, including disabilities and deaths, is fraud…and criminal….and just because the US government knew about Pfizer’s fraud doesn’t make it legal, even under the PREP Act.

Is HHS Pursuing Recommendations to Issue a Class 1 recall?

Under 300aa-23(2)(C), the law clearly states that a manufacturer can be convicted of fraud, false and misleading labeling, and other crimes if the manufacturer engaged in other criminal or illegal activity related to the safety and efficacy of vaccines.

Given the substantial increase in reported adverse events and the government’s admission of fraud, these are compelling legal arguments for the immediate withdrawal of COVID-19 mRNA vaccines from the market.

Did the CDC Engage in Fraud Too

On September 19, 2025, Professor Levi of the CDC’ vaccine advisory committee stated, “Working group members felt the CDC currently does not appropriately acknowledge several safety concerns and uncertainties and multiple documented unintended mechanism of actions of the mRNA vaccines and seemingly regulatory violations.”

VAERS Reported Deaths

As of May 18, 2025, data from the Vaccine Adverse Event Reporting System (VAERS) reports that 22,231 deaths occurred in 2021 following COVID-19 vaccinations, surpassing the total number of vaccine-related deaths reported in the previous 30 years combined.

Approximately one-third of these fatalities occurred within the first 3 days post-vaccination. 38,541 deaths, 220,701 hospitalizations, 247,657 doctor’s visits, 156,638 urgent care, 73,461 permanently disabled, and 51,681 cardiac complications have been reported through March 2025.

Since Novavax’s authorization in August of 2024, 744 reports have been filed in VAERS, including 7 deaths.

By June of 2022 Pfizer Documented Nearly 5 Million Harmful Outcomes (including 3,814 deaths) in Nearly 1.5 Million Injected Individuals

FDA Has Authority to Issue a Class 1 Recall When Any Diseases or Injuries Have Occurred from Use of the Product

Per 21 CFR § 7.41, the FDA has the authority to issue a Class 1 recall when:

• any disease or injuries have already occurred from the use of the product.

• any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard (i.e. shedding). Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.

The FDA Needs HHS Data Reports to Issue a Recall

In multiple public settings, former CBER Director Peter Marks openly bragged that he was blocking Secretary Kennedy from accessing vaccine safety data.

While many influencers are not covering the last ACIP meeting or are condemning its members for not recommending recalling the shots, keep in mind that HHS regulations state that prior to issuing a Class 1 recall all health hazards and risks, “must be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination,” which was the entire point of the September 19, 2025 ACIP meeting.

Articles on CDC ACIP Meeting:

• CDC Advisors Disclose the Links Between COVID-19 mRNA Shots and Cancer

• Pfizer Denies Significant Increased Rate of Birth Defects in COVID-19 Vaccine Study

• COVID-19 mRNA Injections Are Undergoing Major Federal Policy Changes

Romans 5: 2-5

And we boast in the hope of the glory of God. Not only so, but we also glory in our sufferings, because we know that suffering produces perseverance; perseverance, character; and character, hope. And hope does not put us to shame, because God’s love has been poured out into our hearts through the Holy Spirit, who has been given to us.

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