FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data. The trials ‘can provide reassurance that the American repeat-boosters in-perpetuity strategy is evidence-based,’ officials said. By Zachary Stieber (05/21/25, updated 05/26/25, 05/27/25)

tinyurl.com/mr2v8bk6 (may require subscription to Epoch Times)

SUMMARY (Grok ai, with edits; images from the Epoch Times and New England Journal of Medicine articles)

Overview

The U.S. Food and Drug Administration (FDA) announced on May 20, 2025, that it will not approve COVID-19 vaccines for most Americans without clinical trial data demonstrating that benefits outweigh risks, marking a shift from its previous broad authorization approach.

The new two-tier framework requires only antibody evidence for those aged 65 or older and high-risk individuals, while others need randomized, controlled trials showing prevention of symptomatic COVID-19 and severe outcomes.

This change, led by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, aligns U.S. policy closer to other high-income nations’ targeted recommendations, addressing concerns about repeated boosters and insufficient evidence for universal vaccination.

Key Policy Changes

• Two-Tier Framework:

  • For ages 65+ and high-risk individuals: Vaccine approval requires proof of antibody response.

  • For others: Requires randomized, controlled trials showing prevention of symptomatic COVID-19 and severe outcomes like hospitalization or death.

• Contrast with Prior Policy: Previously, the U.S. authorized vaccines for all over 6 months without trial data for updated formulations, unlike countries like Australia and Germany, which limit recommendations to older or high-risk groups.

Rationale and Criticism

• FDA’s Reasoning:

  • Aims to ensure evidence-based vaccine approvals.

  • Rejects the idea that Americans cannot handle age- or risk-based recommendations.

  • Notes unclear benefits of repeated boosters for healthy individuals.

• Criticism:

  • Dr. Sean O’Leary from the American Academy of Pediatrics expressed concerns that limiting vaccine access could reduce protection against post-COVID conditions, potentially increasing disease spread, as seen with measles outbreaks.

Recent FDA Actions

• 2024 Approvals: Approved updated Pfizer and Moderna vaccines and extended emergency authorization for others without trial data.

• Novavax Approval: On May 16, 2025, approved Novavax’s protein-based vaccine for those 12 and older, with restrictions.

Broader Context

• Health Secretary’s Stance: Robert F. Kennedy Jr. pledged placebo-controlled trials for new vaccines on April 30, 2025.

• Vaccine Safety Concerns: FDA has referred safety inquiries to the Department of Health and Human Services, which acknowledges current safety systems’ limitations and is working on improvements.

• Global Comparison: Other high-income nations recommend vaccines only for older adults or high-risk groups, contrasting the U.S.’s prior universal approach.

ED NOTE

This is a step in the right direction, but...

🛑💉LET'S STOP AVOIDING THE TRUTH. LET'S STOP ADMINISTERING THE FAILED COVID SHOTS TO ANYONE — before more people are injured or killed by them. The spike protein in all these shots is dangerous, and the mRNA gene therapy shots (Pfizer and Moderna) cause the body to make uncontrollable amounts of spike for an unknown amount of time.

Most vaccines — including mRNA platform gene therapies like the COVID shots — employ failed technology and erroneous science, despite their long history of development and use. 

Many vaccine targeted diseases are rare in high-income countries such as the US; many targeted diseases are benign (or even strengthen the immune system); and most can be treated early at relatively low cost when such treatments are not censored or forbidden.

Many doctors and scientists now understand that typically-used methods of measuring serum antibodies (serology) do not necessarily correlate to protection from disease (mucosal IgA antibodies and cytotoxic T-cell reactions are more effective measurements — see tinyurl.com/45wvw7vy). 

***
From A Midwestern Doctor (see tinyurl.com/ms2v9abc): "Pfizer has admitted to the FDA that antibody titers do not correlate with immunity to COVID-19."
***

So, serum antibody measurements planned by the FDA for COVID shots targeted at 65 and over and high-risk individuals likely are a poor proxy for actual protection. FDA doctors and scientists should acknowledge these limitations and not use "triggering antibody production" as a "call it good" standard for any vaccine, especially one given to vulnerable people who may be less able to deal with adverse side effects from COVID shots.

It's high time we defund and stop administering COVID shots to anyone — all ages, regardless of "vulnerable status" or "comorbidities.” COVID shots do not stop transmission, they do not prevent severe disease and hospitalization, and they have killed and disabled more than all other VAERS-reported vaccines combined!

FDA References:

• An Evidence-Based Approach to Covid-19 Vaccination. New England Journal of Medicine. Authors: Vinay Prasad, M.D., M.P.H., and Martin A. Makary, M.D., M.P.H. (05/20/25): tinyurl.com/f227fjhf

• May 22 2025 Vaccines and Related Biological Products Advisory Committee Briefing Document: tinyurl.com/bd3r545j

• May 22 2025 Vaccines and Related Biological Products Advisory Committee Meeting Presentation FDA: tinyurl.com/bddn7a62

Related:

• OpenVAERS Covid Vaccine Data: tinyurl.com/yc76t5xe

• 🆕 BREAKING NEWS! COVID-19 vaccine will no longer be recommended for healthy children and pregnant women: tinyurl.com/23zbp69p

• FDA eases on COVID-19 vaccination, but did they go far enough? Q&A 152. Dr. McCullough says New England Journal of Medicine article by Drs. Prasad and Makary and new FDA framework on COVID-19 shots misses the mark (05/22/25, podcast 58 min): tinyurl.com/3xhbhnyv

• Why the Covid Vaccines Were Never Likely to Be Effective. Honest scientists raised key red flags for these vaccines in a top medical journal. They were all ignored. By A Midwestern Doctor (06/05/22): tinyurl.com/ms2v9abc

• The Real Evidence Behind the Vaccinated Blood Controversies. Critical Thinking in The Age of Censorship Pt. 2: Responding to the "Fact-Checkers". By A Midwestern Doctor (12/04/22): tinyurl.com/mr4xd2bc

• Rethinking How We Measure Immunity… using measles as an example. By Dr. Kevin Stillwagon (03/24/25): tinyurl.com/45wvw7vy

• 🛑💉STOP THE SHOTS: It's high time we defund and stop administering COVID shots to anyone — all ages, regardless of "vulnerable status" or "comorbidities.” (Substack Note posted 05/24/25): tinyurl.com/eks24xfz

• Covid Essential Links (especially the books section): tinyurl.com/4x23jysr