FDA Unveils New Plan to Limit COVID-19 Vaccine Use — Keeps Deadly Program Alive
It’s a step in the right direction, but these shots must be REMOVED.
This article originally appeared on Focal Points and was republished with permission.
Guest post by Nicolas Hulscher, MPH
The FDA’s new approach — allowing “high-risk” infants to be injected — disregards millions of American deaths, injuries, and disabilities.
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:
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.
Excess Mortality – >12 studies and VAERS confirm mass COVID-19 'vaccination' led to a catastrophic number deaths worldwide -- up to 17 million.
FDA Class I Recall Indicated – 37,544 VAERS-reported deaths exceed past vaccine recall limits by up to 375,340%.
Negative Efficacy – >6 studies have demonstrated that COVID-19 'vaccination' increases your risk of SARS-CoV-2 infection.
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.
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
Epidemiologist and Foundation Administrator, McCullough Foundation
www.mcculloughfnd.org
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