FDA Unveils New Plan to Limit COVID-19 Vaccine Use — Keeps Deadly Program Alive

The FDA’s new approach — allowing “high-risk” infants to be injected — disregards millions of American deaths, injuries, and disabilities.

by Nicolas Hulscher, MPH

In a new policy statement published in The New England Journal of Medicine, Drs. Vinay Prasad and Marty Makary outline the FDA’s newly formalized tiered strategy for authorizing future COVID-19 vaccines:

The FDA’s New COVID-19 Vaccine Plan

“High-Risk” Populations (65+ and individuals with comorbidities, including infants 6 months+ and pregnant women):

Vaccines will continue to be authorized based solely on immunogenicity — the ability to generate antibody titers — without requiring demonstration of clinical benefit through randomized controlled trials (RCTs).

“On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC.”

Moderate-Risk Populations (Age 50–64 without risk factors):

The FDA will encourage postmarketing RCTs in this group but will not delay authorization while evidence is being collected.

Healthy Individuals (6 months to 64 years, no risk factors):

The FDA now states that future authorization will require RCTs demonstrating clinical outcomes — such as prevention of symptomatic COVID-19, hospitalization, and death.

Tinkering with Policy Won’t Undo Catastrophic Harm — These Products Must Be Recalled

This new regulatory approach ignores the fact that millions of Americans have been killed, injured, or permanently disabled by COVID-19 vaccines. Two independent estimations — one based on VAERS-adjusted data, the other derived from MIT/Florida Dept. of Health study findings — yield a conservative range of 470,000 to 600,000 American deaths from the COVID-19 mRNA shots. The true number is likely much greater.

When a genetic product causes more American casualties than World War I, World War II, and the Vietnam War combined, basic common sense dictates that its use must be halted entirely — not continuously administered to “high-risk” individuals.

Our peer-reviewed study titled, Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits, provides the full evidence-based rationale for the immediate withdrawal of these dangerous products:

BREAKING - Peer-Reviewed Study Finds Irrefutable Evidence Supporting Immediate Market Withdrawal of COVID-19 "Vaccines"

1. Widespread & Unified Calls for Market Withdrawal – More than 81,000 physicians, scientists, and concerned citizens, 240 elected officials, 17 public health & physician organizations, 2 State Republican Parties, 17 GOP County Committees, and 6 global studies demand immediate removal.

2. Excess Mortality – >12 studies and VAERS confirm mass COVID-19 'vaccination' led to a catastrophic number deaths worldwide -- up to 17 million.

3. FDA Class I Recall Indicated – 37,544 VAERS-reported deaths exceed past vaccine recall limits by up to 375,340%.

4. Negative Efficacy – >6 studies have demonstrated that COVID-19 'vaccination' increases your risk of SARS-CoV-2 infection.

5. DNA Contamination – >11 reports have found DNA contamination in COVID-19 vaccines, documented across multiple manufacturers, vaccine platforms, and geographic regions, with levels exceeding regulatory thresholds by up to 65,500%.

The FDA’s new policy is a quiet acknowledgment that the prior “one-size-fits-all” vaccine strategy was unscientific and unjustified. But admission without accountability is not enough. COVID-19 mRNA injections are neither safe nor effective. They have caused massive harm and incalculable loss of life. Continuing to authorize these products for any group is a profound violation of public trust — and contrary to the FDA’s belief, their new plan won’t restore confidence, but will only expand the black hole of public distrust.

The COVID-19 shots must be removed from the market. Not rebranded. Not reauthorized. Removed.

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References

Prasad V, Makary MA. An Evidence-Based Approach to Covid-19 Vaccination. New England Journal of Medicine, May 20, 2025. [DOI: 10.1056/NEJMsb2506929]

Hulscher N, Bowden M T., McCullough P A.. Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits. Science, Public Health Policy and the Law. 2025 Jan 28; v6.2019-2025

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Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

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