Friday, 31 Oct 2025
  • Contact
  • Privacy Policy
  • Terms & Conditions
  • DMCA
logo logo
  • World
  • Politics
  • Crime
  • Economy
  • Tech & Science
  • Sports
  • Entertainment
  • More
    • Education
    • Celebrities
    • Culture and Arts
    • Environment
    • Health and Wellness
    • Lifestyle
  • đŸ”„
  • Trump
  • VIDEO
  • House
  • White
  • ScienceAlert
  • Trumps
  • Watch
  • man
  • Health
  • Season
Font ResizerAa
American FocusAmerican Focus
Search
  • World
  • Politics
  • Crime
  • Economy
  • Tech & Science
  • Sports
  • Entertainment
  • More
    • Education
    • Celebrities
    • Culture and Arts
    • Environment
    • Health and Wellness
    • Lifestyle
Follow US
© 2024 americanfocus.online – All Rights Reserved.
American Focus > Blog > Politics > FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data
Politics

FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

Last updated: May 22, 2025 6:40 am
Share
FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data
SHARE

This article was originally published by The Epoch Times: FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

In a thrilling twist reminiscent of a medical thriller plot, the FDA has declared that many Americans will not see the green light for COVID-19 vaccine approvals without robust trial data to back them up. This announcement was made on May 20, with officials emphasizing that the trials are essential for ensuring the American public isn’t subjected to a perpetual cycle of booster shots based on little more than hope.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, who leads the FDA’s Center for Biologics Evaluation and Research, explained that the new vaccine approval framework is structured in two distinct tiers. For those aged 65 and older, or for individuals with certain risk factors that put them at higher risk for severe COVID-19 outcomes, manufacturers will only need to demonstrate that a vaccine can stimulate antibody production. Meanwhile, for everyone else—those who are young and sprightly without risk factors—the FDA is calling for rigorous randomized controlled trials to showcase that a vaccine actually prevents symptomatic COVID-19 and its more sinister side effects, such as mortality.

“The FDA can only approve products if it concludes, based on scientific evidence, that the benefits outweigh the risks. We simply need more data to have that confidence for younger individuals at low risk of severe disease,” Prasad stated in prepared remarks from the FDA’s headquarters in Maryland.

These trials won’t be an annual affair, but they’re expected to occur every few years. An estimated 100 million to 200 million Americans will fall into that first tier, according to estimates from a New England Journal of Medicine article.

See also  Democrat Caller to Chris Cuomo Show: 'I'm Not Too Proud to Say I was Wrong About Trump' (VIDEO) |

“Finally, the FDA is acknowledging the need for ‘evidence-based medicine’ and controlled trials to support the concept of unending boosters,” remarked Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, in an email to The Epoch Times.

While Novavax chose to remain tight-lipped, Pfizer and Moderna were nowhere to be found for comment. However, Dr. Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, expressed his concerns regarding the FDA’s decision to limit COVID-19 vaccine availability. “Vaccination provides significant protection from post-COVID conditions,” he argued. “As demonstrated by the current measles outbreak, lower vaccination rates lead to more disease. Widespread access to immunizations keeps our communities and children healthier.”

In a not-so-distant memory, the FDA had previously approved updated versions of the Pfizer and Moderna vaccines for most Americans in 2024, extending emergency authorization despite the absence of trial data for those formulations. Not to be overshadowed, the agency also approved Novavax’s COVID-19 vaccine for adults aged 65 and older, while those aged 12 to 64 could receive it only if they had high-risk conditions.

Currently, the Centers for Disease Control and Prevention recommends that individuals aged six months and older receive one of the latest COVID-19 vaccines. However, only 13 percent of children and 23 percent of adults have bothered to follow this guidance.

Makary and Prasad pointed out that numerous other nations, including Australia and Germany, limit vaccine recommendations to specific populations. “While high-income countries generally restrict vaccine recommendations to older adults or those at high risk for severe COVID-19, the U.S. has adopted a one-size-fits-all approach, granting broad marketing authorization to all Americans over six months old,” they noted. “This policy has sometimes been defended by suggesting that the American public lacks the sophistication to understand age- and risk-based recommendations. We reject this view.”

See also  Trump’s WAR on Big Pharma Begins — MASSIVE Tariffs Will Change EVERYTHING! | Elijah Schaffer’s Top 5 (VIDEO) |

Despite the impressive speed with which COVID-19 vaccines were developed—a genuine scientific triumph—the benefits of repeated dosing remain murky. The proposed trials will evaluate the prevention of symptomatic COVID-19, with secondary outcomes such as severe disease, hospitalization, and death. Participants who contracted COVID-19 within the past year will be monitored for at least six months to ensure that any initial booster benefits hold up over time. The control group could receive a saline placebo, a method that has not been lost on those familiar with the scientific method.

“Ultimately, these studies can provide assurance that the American strategy of continuous booster shots is indeed grounded in evidence,” they concluded.

Health Secretary Robert F. Kennedy Jr. recently expressed a commitment to requiring placebo-controlled trials for new vaccines—a move that raises eyebrows and expectations alike. Orient emphasized that the FDA should have previously disclosed the safety risks associated with the vaccines.

The FDA has been redirecting requests for comment to the Department of Health and Human Services. A spokesperson for the department informed The Epoch Times that current vaccine safety systems are inadequate and that efforts are underway to build better systems.

If you found this article interesting, please consider supporting traditional journalism

Our first edition was published 25 years ago from a basement in Atlanta. Today, The Epoch Times brings fact-based, award-winning journalism to millions of Americans.

Our journalists have faced threats, arrests, and assaults, but our commitment to independent journalism has never wavered. This year marks our 25th year of independent reporting, free from corporate and political influence.

See also  Food insecurity causes anxiety and depression, data show

That’s why you’re invited to a limited-time introductory offer — just $1 per week — so you can join millions already celebrating independent news.

TAGGED:AmericansCovid19DataFDALicensesTrialVaccines
Share This Article
Twitter Email Copy Link Print
Previous Article Alix Earle Joins ‘Dancing With the Stars’ Season 34 Alix Earle Joins ‘Dancing With the Stars’ Season 34
Next Article Despite No. 6 seed, Novak Djokovic lucks out with better French Open 2025 draw Despite No. 6 seed, Novak Djokovic lucks out with better French Open 2025 draw
Leave a comment

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Popular Posts

From F1 Academy firsts to unique roots, Chloe Chambers breaks the motorsports mold

Chloe Chambers' rise to success in the world of motorsports is nothing short of remarkable.…

October 4, 2024

RFK Jr. on addiction treatment, unpacking PBM legislation

The debate over addiction policy is heating up, with Robert F. Kennedy Jr. advocating for…

December 13, 2024

Carrots Kill One As Multi-State E.coli Outbreak Sickens Dozens

Organic Carrots Linked to E.coli Outbreak: What You Need to Know The recent E.coli outbreak…

November 17, 2024

Many Medical Providers End Transgender Youth Procedures After Trump Order

President Trump Signs Executive Order Restricting "Transgender" Procedures on Youth Late last month, President Donald…

February 10, 2025

Tay Kolma Death, Mon Mothma Dancing at Wedding Explained

The second season of "Andor" on Disney+ has kicked off with a bang, as Mon…

April 23, 2025

You Might Also Like

Democrats plot messaging blitz ahead of Obamacare hikes
Politics

Democrats plot messaging blitz ahead of Obamacare hikes

October 31, 2025
IVF research, FDA vouchers, dementia: Morning Rounds
Health and Wellness

IVF research, FDA vouchers, dementia: Morning Rounds

October 31, 2025
Heritage president backs Tucker Carlson after interview with Holocaust-denier Nick Fuentes
Politics

Heritage president backs Tucker Carlson after interview with Holocaust-denier Nick Fuentes

October 30, 2025
Trump turns up the pressure on Indiana Republicans to redistrict
Politics

Trump turns up the pressure on Indiana Republicans to redistrict

October 30, 2025
logo logo
Facebook Twitter Youtube

About US


Explore global affairs, political insights, and linguistic origins. Stay informed with our comprehensive coverage of world news, politics, and Lifestyle.

Top Categories
  • Crime
  • Environment
  • Sports
  • Tech and Science
Usefull Links
  • Contact
  • Privacy Policy
  • Terms & Conditions
  • DMCA

© 2024 americanfocus.online –  All Rights Reserved.

Welcome Back!

Sign in to your account

Lost your password?