Makary criticizes past federal COVID vaccine moves, calls ACIP a ‘kangaroo court’

Martin Makary, commissioner of the US Food and Drug Administration (FDA), called the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) a “kangaroo court” for rubber stamping COVID-19 vaccine recommendations in a sometimes-confrontational interview on CBS’ Face the Nation on Sunday.

Makary also claimed that there is no data to support recommending COVID-19 boosters for healthy children and healthy pregnant people and defended the Trump Administration’s moves to limit boosters for healthy children and pregnant people. (RELATED: FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people, Regulatory Focus 20 May 2025)

“We believe the recommendation should be between the patient and their doctor so we're going to be getting away from these blanket recommendations in healthy, young, Americans because on the COVID vaccine schedule we don't want to see kids kicked out of school because a 12-year-old girl is not getting her fifth COVID booster shot,” he said. “We don't see the data there to support a young healthy child getting a repeat infinite annual COVID vaccine.”

Makary claimed there is no scientific reason to keep healthy children on the COVID-19 vaccine schedule. But since the announcement early last week, CDC has updated its policy stating that people 6 months to 17 years old who are not moderately or severely immunocompromised may receive the vaccine based on shared clinical decision-making with their healthcare provider. The agency removed its previous recommendation for pregnant women to receive the vaccines, and its guidance now states “no guidance/not applicable,” when it comes to the cohort. The CDC has also added an advisory to other pages on its website that recommend COVID-19 boosters for everyone ages six months and older, including pregnant people, stating that it will update the page to align with recent changes to its COVID-19 vaccine recommendations.

Face the Nation host Margaret Brennan noted that taking healthy children off the vaccine schedule meant that those who had never received the vaccine would not have to take it in the first place. Makary countered that the administration did not want to require the vaccine for healthy children without any clinical data supporting it.

Brennan also pointed out that according to the CDC's own data, 41% of children between the ages of 6 months and 17 years old who were hospitalized with COVID-19 between 2022 and 2024 did not have a known underlying condition. "In other words, they looked healthy and COVID was serious for them," she said.

Makary said that the CDC’s data was known to be "contaminated with a lot of false positives," and that under the Biden administration, it did not distinguish whether the patient was in the hospital for COVID-19 who were in the hospital and had an incidental positive COVID-19 test.

“When you go to an [intensive care unit (ICU)] in America and you ask how many people are in the ICU that are healthy that are sick with COVID, the answer I get again and again is ‘We haven't seen that in a year or years,’” he said.

Brennan asked why FDA made the decision to change its approval standards for COVID-19 vaccines without input from ACIP.

"That panel has been a kangaroo court where they just rubber stamp every single vaccine put in front of them," said Makary. He said the committee doesn’t make decisions based on data but rather for “marketing and ease.”

Paul Offit, a pediatrician at the division of infectious diseases at Children's Hospital of Philadelphia and a member of FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), took issue with Makary’s characterization. He said the commissioner hasn’t been paying attention to what ACIP does and said that the committee’s decisions are based on data they are presented with.

“This slanderous talk is to what end? I guess it's to impress a similar conspiracy theorist like his boss,” Offit said, referring to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. Offit added that Kennedy “doesn't believe these committees serve a purpose because we're all deeply in the pocket of the pharmaceutical industry, which is also nonsense,” he told Focus. “If he's going to make these kinds of claims, prove it. Otherwise, it's just slanderous and ill-informed.”

Former FDA Commissioner Robert Califf said he hopes Makary misspoke when discussing ACIP.

“I’m hoping that the ‘kangaroo court’ comment was a misstatement in the heat of an interview in which Dr. Makary was being pressed,” Califf told Focus. “One may disagree with the ACIP recommendations, but this is a talented group of professionals from a variety of backgrounds, including serious clinical care and evidence generation experiences.”

“Despite their differences, they spent years in very difficult times with one goal: To make the best recommendations for public health,” he added.

Califf said he is looking forward to ACIP's June meeting where the committee will provide data and analyses of the current state of the SARS-CoV-2 virus and discuss recommendations to fight COVID-19.

Califf favors conducting randomized controlled trials with COVID-19 vaccines for low-risk adults, especially to look at the effects of long COVID. He said such trials would clarify the benefit-risk of taking the vaccines in low-risk populations.

“I believe the evidence on the benefits outweighing risks in pregnant women and their infants are strong,” he added.

Offit also noted that CDC data shows that at least 40% of children who have died from COVID-19 had no underlying condition. He also said pointed out that Makary recently published a paper that lists pregnancy as a high-risk factor for COVID-19. Furthermore, he added that the World Health Organization (WHO) and almost all other countries treat pregnancy as a high-risk factor among other respiratory diseases since they have found that infected pregnant people are 1.5 to 2 times more likely to die of COVID-19.

"What he's doing is putting children and pregnant women in harm's way unnecessarily," said Offit.

Offit opined that the COVID-19 vaccine mandates “rubbed people the wrong way,” and as a result, libertarian-leaning politicians and policymakers are coming after government institutions so they cannot impose mandates in the future.

"I think we leaned into a libertarian left hook with mandates and we're feeling the punch," said Offit.

Offit said the number of hospitalizations and deaths in children less than four years of age is around where it was before COVID-19 vaccines were available. As the virus continues to circulate and vaccination for children continues to fall, he worries that more children will die. While he thinks insurance companies will continue to cover vaccines for children and pregnant women, he fears the administration’s decision will lead to further loss of confidence in the vaccines from parents.

"We need to stand up for children in this country and add this as a full recommendation and keep pushing back on that," said Offit. "The reason [Makary] can get away with it is because you don't know who those children are.

“There will be children who will die from this, and if you knew their names now, then we would feel differently," he added.

Face the Nation

Makary criticizes past federal COVID vaccine moves, calls ACIP a ‘kangaroo court’

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