Brace yourselves, folks—the Food and Drug Administration is gearing up to overhaul vaccine approval standards after a shocking memo tied at least 10 child deaths to COVID-19 shots.
According to The Hill, reported on November 29, 2025, this development signals tighter guidelines that could reshape how vaccines for various illnesses, including annual flu shots, are developed and administered, while also limiting shots for pregnant women and slowing manufacturer timelines with demands for larger studies.
Earlier in 2025, Department of Health and Human Services Secretary Robert F. Kennedy Jr., known for his vaccine skepticism, revived a dormant task force focused on childhood vaccine safety.
By August 2025, the FDA was already mulling over revoking emergency use authorization for Pfizer’s COVID-19 vaccine for healthy children under 5 years old.
At the same time, updated vaccines were greenlit for those deemed high risk, though routine COVID-19 shots are no longer advised for healthy kids or pregnant women.
The new rules, as detailed in documents obtained by The New York Times, might even affect whether Americans can receive multiple vaccines at once—a policy shift that could disrupt long-standing public health practices.
Vinay Prasad, a key FDA vaccine regulator reinstated in August 2025 after facing conservative backlash, has pushed for pneumonia vaccine makers to prove their products actually cut infection rates, not just boost antibodies.
Prasad also mandated that randomized studies cover all demographic subgroups and didn’t hold back on critiquing the current flu shot framework as a “catastrophe of low-quality evidence,” as reported by The New York Times.
While his bluntness might ruffle feathers, it’s hard to argue against demanding solid proof in an era where trust in institutions often feels like a rare commodity.
The memo at the heart of this shake-up claims at least 10 children died due to COVID-19 vaccinations, though it lacks specific details about these tragic cases.
Prasad didn’t mince words, calling it “a profound revelation,” and added, “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children,” according to The Washington Post.
Such a statement lands like a thunderclap, though skeptics might wonder if this is more about political posturing than science—still, the loss of even one child demands serious scrutiny over bureaucratic complacency.
Not everyone is on board, with critics like Jesse Goodman, the FDA’s former chief scientist, defending the status quo by saying, “They’re being approved with strong scientific evidence,” as told to The Washington Post.
That confidence might reassure some, but in a climate where big pharma often seems to dodge accountability, insisting on rigorous data isn’t just prudent—it’s a moral imperative, especially when children’s lives are on the line.