The U.S. Food and Drug Administration (FDA) has announced that regulators will no longer approve Covid “vaccines” for use on the American people without trial data proving that they don’t cause severe outcomes such as heart failure and cancer.
The update was revealed in a New England Journal of Medicine article written by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research.
They explained that the FDA will no longer approve any Covid “vaccines” without evidence that the claimed “benefits” far outweigh the risks.
In the article, Drs. Makary and Prasad wrote:
“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: 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.
“For all healthy persons—those with no risk factors for severe COVID-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”
Pharmaceutical giants Pfizer, Moderna, and Novavax all received licenses for their Covid “vaccines,” including their so-called “booster” shots, which continue to be produced long after the pandemic.
In 2024, in its most recent action concerning the Pfizer and Moderna “vaccines,” the FDA approved updated versions of the mRNA injections for most Americans.
The FDA extended emergency authorization for the “boosters,” despite there being no trial data available for those formulations.
On May 16, the regulatory agency approved Novavax’s Covid “vaccine” for the first time.
The approval was for adults aged 65 and up.
However, the agency said that people aged 12 to 64 could receive a Novavax shot, but only if they have one of the conditions that put them at higher risk for “severe COVID-19 outcomes.”
An earlier version of Novavax’s shot was tested in a randomized, controlled trial in 2021.
The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that people aged 6 months and older receive one of the latest Covid injections.
However, just 13 percent of children and 23 percent of adults have followed that recommendation.
Makary and Prasad noted that a number of other countries, such as Australia and Germany, only recommend Covid “vaccines” to certain populations.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” they wrote on Tuesday.
“The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.
“We reject this view,” they noted.
The officials said that while the quick development of Covid “vaccines” was a scientific and medical achievement.
However, the benefit of repeated dosing, as some people have received at least six doses, is unclear.
The trials of the vaccines should measure prevention of symptomatic COVID-19.
Secondary endpoints must include severe COVID-19, hospitalization, and death, according to Makary and Prasad.
They said that the trials should include participants who contracted COVID-19 within the past year, and they should follow participants for at least six months “to ensure that early booster gains persist.”
The control group could receive a saline placebo, the officials said.
“Ultimately, these studies alone can provide reassurance that the American repeat-boosters in perpetuity strategy is evidence-based,” they wrote.
Health Secretary Robert F. Kennedy Jr. recently pledged to require placebo-controlled trials for new vaccines.
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