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May 20, 2025

"A Restoration of... Trust:" FDA Will Stop Recommending the Clot-Shot to Anyone Under 65

So they've joined the Russian Conspiracy Theory too.

Did you know that the FDA approval process for the COVID vaccines does not require that the shots be safe and effective?

It doesn't, and never has. All that has been required is that the vaccines be proven to increase antibodies, which is a very low and atypical standard.


Vaccine approval for people over 65--those who face the greatest risk from COVID and who are most likely to have a favorable risk/reward profile--will remain the same as before, but for anybody under 65, the approval standard will be the more common and more stringent standard of proven clinical benefit.


From the Free Press:

In a paper published today in The New England Journal of Medicine, Martin Makary, the commissioner of the Food and Drug Administration, and Vinay Prasad, the newly appointed head of the FDA's vaccine division, have unveiled a new policy in which the government will no longer recommend Covid booster shots for healthy Americans ages 64 and younger.

In addition, as of today, Covid vaccine manufacturers like Moderna and Pfizer will have to conduct trials to prove that their updated vaccines offer clinical benefits such as fewer symptoms, hospitalizations, or deaths. Previously, pharmaceutical companies only had to show that their updated booster shots produced antibodies. That less rigorous standard will still apply for people 65 and older and the immunocompromised.

It is well established that people 65 and older account for the vast majority of Covid deaths, while most children, in particular, show few effects from the virus.

In an exclusive interview with The Free Press, Prasad said that the previous one-size-fits-all approach--in which the federal government recommended Covid vaccine boosters for everyone, including healthy 6-month-olds--"fatigued" the country.


"The American people were skeptical, and some of them took that skepticism to every single vaccine, which has led to some big problems," said Prasad, referring to the fact that a growing number of Americans have stopped having their children vaccinated for measles, mumps, and rubella, leading to measles outbreaks in pockets of the country. "This is a restoration of that trust. It's bringing us back to evidence."

The move is one part of what is expected to be further changes in federal Covid vaccine policy. According to The Wall Street Journal, Health and Human Services Secretary Robert F. Kennedy Jr. plans to scrap guidelines recommending routine Covid vaccinations for pregnant women, teenagers, and children. Late last month, in an interview with Phil McGraw (popularly known as Dr. Phil), Kennedy advised parents to "do your own research" before vaccinating their newborns. That skepticism is increasingly shared by the public: Less than a quarter of Americans received boosters in recent years, according to Makary and Prasad's paper. Even healthcare workers have been slow to roll up their sleeves--fewer than one third reported getting a booster in 2023.







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