URGENT: The FDA will reject future Covid jabs for healthy people under 65 without big new clinical trials proving they work
This move does not go far enough - a long list of chronic conditions means most adults will still be eligible for boosters - but it is the first real step to rein in American mRNA fanatics
The clawback against the overuse of mRNA Covid shots has finally begun.
It has a long way to go.
In an opinion piece Tuesday morning, two top Food and Drug Administration officials announced new guidelines effectively ending approval of new Covid shots for healthy people under 65. Vaccine companies will have to run expensive new trials before the FDA okays new jabs for those people, a step the companies probably won’t take.
But the restrictions aren’t nearly as strict as mRNA critics would hope. Many Americans under 65 will still be able to get boosters without big trials, the officials said.
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(The truth you need. FAST.)
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As a result, shares in Moderna — the company most associated with and dependent on mRNA shots — actually rose over 10 percent after the announcement.
The compromise is yet more evidence of the heavy pressures facing Robert F. Kennedy Jr., the Secretary of Health and Human Services, as he tries to exert control over the American healthcare-industrial complex, which has annual revenues of an unthinkable $5 trillion and a massive lobbying apparatus.
Drs. Marty Makary, the new FDA commissioner, and Vinay Prasad, the new head of the FDA division that regulates vaccines, made the announcement in an article in the New England Journal of Medicine called “An Evidence-Based Approach to Covid-19 Vaccination.”
They said the FDA will not okay new Covid booster shots for healthy adults under 65 unless vaccine companies run placebo-controlled trials that show the boosters actually reduce symptomatic Covid — and ideally hospitalization and death as well.
The companies are very unlikely run those trials, as they would be very expensive and might well fail to show any benefit. Without new boosters, Covid vaccine fanatics will finally have to end their indefensible efforts to push mRNA shots — whose long-term impacts look worse and worse — on healthy kids and adults.
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(Following the evidence. At least some of it…)
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However, the new plan has a loophole the size of a tractor-trailer filled with heavily iced Cinnabon buns.
Makary and Prasad said adults under 65 at risk for “severe Covid” would remain eligible for boosters approved under much looser rules. And they said the FDA would follow Centers for Disease Control guidelines to determine that risk category.
The CDC guidelines are extremely loose, including smokers, pregnant women, anyone with diabetes, and most notably any person who is even mildly obese, with a BMI over 30- a category that by itself includes about 40 percent of American adults. The CDC even includes “physical inactivity” as a risk factor — a group that might be as many as 75 or 80 percent of adults depending on how inactivity is defined.
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(The truth. You may not like it, but I’ll give it to you straight.)
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So as a practical matter, the new plan will do little to make mRNA shots less accessible. Almost everyone who got the shots over the last couple of years can still do so.
Still, for the first time, Kennedy and his new FDA hires have followed the growing evidence on the potential long-term harms of mRNA vaccines for healthy people and restricted their use.
It’s a step in the right direction.
A small one.
Shove whatever you want into your body, just don't mandate that me or my children do.
Weak. Sad state of affairs, THE JABS DONT WORK. Who are they afraid of? Can we ever just stop the madness?