On Tuesday, the FDA announced a sweeping ban on COVID-19 booster shots for approximately 90% of Americans, restricting access to those aged 65 or older and high-risk individuals. Citing concerns over the boosters’ potential harm and unproven benefits for the broader population, this decision marks a significant shift in the agency’s pandemic response strategy.
In a detailed article published in The New England Journal of Medicine, FDA Director Martin Makary and Vinayak Prasad, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), outlined the rationale behind this policy change. They argued that the evidence supporting yearly COVID-19 vaccinations for healthy individuals remains inconclusive, prompting the agency to reconsider the practice of “repeat dosing” and prioritize targeted protection for vulnerable groups.
Infowars.com reports: “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 FDA officials wrote.
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“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.”
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The FDA director and CBER director went on to say the agency’s new policy will be to prioritize Covid-19 jabs for people aged 65 and older and people who have a high risk of infection, while vaccine manufacturers will have to obtain approval for a yearly jab targeting healthy people aged 6 months to 64 years by conducting “randomized, controlled trials.”
“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,” the FDA chiefs wrote.
High-risk individuals include people with “obesity and even mental health conditions such as depression,” the officials explained, adding that under the new system some 100 to 200 million Americans would still have access to the jab.
“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.”
Speaking to Reuters, University of Minnesota infectious disease specialist Dr. David Boulware predicted most vaccine companies will not attempt to jump through the regulatory hoops to obtain approval for a yearly jab, “saying it would require large enrollment and could cost ‘hundreds of millions of dollars.’”
The FDA officials argued the new policy more closely aligns with a benefit-risk calculation strategy, noting, “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. This policy will compel much-needed evidence generation.”
“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the officials concluded.