FDA Pulls Recommendation for COVID Shots For Most Americans, Pulls Approval for Under 65s

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. 

Exclusive: FDA to stop automatically recommending Covid boosters for most Americans

‘This is a restoration of trust,’ said @VPrasadMDMPH https://t.co/AvR6WIMH8E

— Olivia Reingold (@Olivia_Reingold) May 20, 2025

Proven clinical benefit? What an odd standard! You mean that tests on a few mice will no longer suffice to get a new booster approved? 

This shift in recommendations should be no surprise. Dr. Vinay Prasad was recently appointed the head of the FDA’s vaccine division, and if you have followed his commentary over the past few years, he has consistently argued for precisely this standard. This also fits with the philosophy behind the Great Barrington Declaration, authored by Dr. Jay Bhattacharya, the new head of the National Institutes of Health. 

Both have argued for focused protection for those who are at high risk, rather than recommending a “one-size-fits-all” approach that creates more risk for less benefit for younger, healthier people. 

Prasad gave an exclusive interview to The Free Press–unsurprisingly, since he has authored numerous articles for them in the past, explaining this shift in approach. 

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.

Even healthcare workers don’t “trust the experts,” which should tell you something. Their vaccination rates are barely above those of the general population. By 2022, even my doctor would no longer recommend the vaccine boosters, not because she was certain that they were unsafe and ineffective, but because she didn’t trust the “experts” to tell the truth about whether they were. 

Neither Prasad nor the FDA Director Martin Makary has asserted that the vaccines are not, in fact, safe and effective. Instead, they point to the fact that the vaccine makers and the FDA never even tried to test whether they were effective at all because it was not required. 

Dr. Paul Offit, a well-known pediatrician specializing in infectious diseases and a member of the FDA’s Vaccines and Related Biological Products Advisory Council, even told Time magazine that he was “uncomfortable” with the agency’s decision to green-light the updated vaccines. The agency’s decision to forgo extensive clinical trials was intended to keep pace with the evolution of the disease. But in their paper, which was shared exclusively with The Free Press, Prasad and Makary said that it was time to return to “gold-standard science.”

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

To Prasad, the new framework is a “common sense approach” that will put the U.S. “much closer to every country in Europe.” Countries such as France, the UK, and Sweden now limit Covid-booster recommendations to the elderly and immunocompromised. In stark contrast, the Centers for Disease Control and Prevention still urges everyone ages 6 months and older to get the 2024–2025 vaccine—regardless of prior infection, risk profile, or number of previous doses.

“We’re finally falling in line with all the other thoughtful people in the world who think it is ridiculous to give a healthy 12-year-old girl her seventh dose without any evidence,” Prasad said. “And we’re not saying we’re never going to do it—we’re just saying: Prove to me it helps her before we do it.”

No doubt, the COVID-obsessed and Trump deranged will try to use this change in policy to slam the changes as proof that the administration is filled with anti-vaccine zealots. 

Ironically, any criticism of this shift is the actual anti-science position. After all, Prasad and Makary are asking the vaccine makers to do some science before getting approval for their products. 

It isn’t asking too much to expect Pharma to prove their products are safe and effective, is it?