Sunday, 08 June 2025

FDA Establishes New Guidelines On Who Has Access To COVID-19 Jabs

100 Percent Fed Up
Hits: 7

The U.S. Food and Drug Administration (FDA) will limit access to COVID-19 jabs to individuals 65 years of age and older and those deemed at risk of developing severe illness.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, outlined the policy change in an editorial published in The New England Journal of Medicine.

“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. 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,” the editorial read.

“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, as described by the CDC,” it continued.

“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. Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment,” it added.

ADVERTISEMENT

CNN reports:

The change means that Covid-19 shots will likely be available in the fall for adults ages 65 and older and those with underlying conditions that may put them at higher risk of a Covid-19 infection, but not for everyone who was previously eligible for an updated shot. Nearly three-quarters of Americans age 6 months and older have an underlying medical condition that puts them at higher risk, according to the US Centers for Disease Control and Prevention.

The change, which was already being studied by experts that advise the CDC on its vaccine recommendations, will more closely align the United States with Covid-19 vaccine recommendations in the UK, Canada and Australia.

Millions of healthy adults and kids will likely lose access to updated vaccines under the new criteria. Prasad and Makary say there’s not enough evidence that healthy kids and adults get clinically meaningful benefit from regular Covid-19 shots. They want to see placebo-controlled trials, particularly in adults ages 50 to 64, before recommending the shots for other groups.

Per Reuters:

Vaccine makers have argued that because COVID vaccines have been changed annually to match the circulating strain of the virus, new placebo-controlled trials could delay availability of the shots until after their usefulness has passed.

But Prasad and Makary say the studies are needed to provide evidence that annual shots for healthy younger Americans are evidence-based.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” Prasad and Makary wrote. “This policy will compel much-needed evidence generation.”

There are currently three approved vaccines for COVID-19 in the U.S.: messenger RNA-based shots made by Moderna Inc and by Pfizer and Germany’s BioNTech, and a protein-based vaccine made by Novavax Inc.


Source link

Search