FDA Commissioner Marty Makary: ‘There’s No Data’ COVID Shots Help Children
Food and Drug Administration (FDA) Commissioner Dr. Marty Makary says he would “love to see the evidence to show that giving young, healthy children another COVID shot … would help them,” but adds, “that evidence does not exist.”
During an interview with Real America’s Voice The Charlie Kirk Show Tuesday, host Kirk put to Makary the fact that the COVID mRNA shot still remains on the childhood vaccination schedule.
“Are you guys thinking about this?” Kirk asked Makary.
“Look, I'd love to see the evidence to show that giving young, healthy children another COVID shot – you know, a sixth COVID booster – would help them,” the commissioner responded. “But that evidence does not exist, and so we're not just going to rubber stamp things at the FDA, and I don't think you're going to see a push at the CDC to be pushing COVID shots in young, healthy children.”
Makary then indicated an “announcement” will be forthcoming within “weeks”:
That is something that's being discussed right now. I think you're going to see some announcement on that in the coming weeks, but I know they are trying to review all of the scientific data. And guess what? There's no data. There's no good randomized control data that the current version, the latest formulation of the COVID shot, is necessary for young, healthy children. Other countries have already recommended against it. Other leading countries in Europe have recommended against it for young, healthy children. So, I think you're going to see a look at this, and you're going to hear something forthcoming.
Makary’s comments come as a group of medical specialists known as Independent Medical Alliance (IMA) – formerly Front Line COVID-19 Critical Care Alliance (FLCCC) – launched Tuesday the “Smart Moms Ask” nationwide campaign “to stop mRNA COVID shots for kids and pregnant women.”
“Building on its highly effective national grassroots activism which helped secure HHS Secretary Robert F. Kennedy Jr.’s confirmation, the IMA’s new ‘Smart Moms Ask’ campaign rallies moms to challenge a medical system that has ignored the growing body of vaccine injury data from COVID mRNA shots,” the campaign’s web page states.
Visitors to the site are urged to sign the campaign’s petition asking the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) “to reverse the CDC’s recommendation for the COVID-19 mRNA shots and take them off the childhood vaccine schedule.”
“The risks are real, and parents deserve the truth,” the parent coalition asserts, citing the following “shocking risks” discovered via peer-reviewed studies:
9.5 million U.S. children aged 6 months to 17 years have received the COVID-19 mRNA shot as of April 19, 2025
620% increase in myocarditis among young men post-vaccination, raising questions about safety in adolescent populations as sourced in a 2025 peer-reviewed study.
Miscarriage rates as high as 81% compared to an average rate of 13% have been reported in a Pfizer Patient Safety study.
~33% lower successful conception for vaccinated women were compared to unvaccinated women in 2022.
“There is no ethical or scientific case for exposing healthy children and pregnant women to these risks,” said Dr. Joseph Varon, IMA president and chief medical officer, in a statement. “HHS and CDC must act swiftly to protect our most vulnerable.”