Updated December 15, 2025 at 3:01 PM EST
FDA Commissioner Martin Makary said the government must show greater humility and be more transparent if it hopes to rebuild public trust in its health guidance, which he said has been badly eroded since the pandemic.
In an interview with NPR's Steve Inskeep, Makary addressed recent controversy over an FDA memo that cited rare reports of child deaths linked to COVID-19 vaccinations. He said the information was not new but had not been made public, and argued that officials failed to clearly communicate how risks varied by age and underlying health conditions, even as vaccines saved many lives.
"The most dangerous thing you can do in medicine is to put out a recommendation with such absolutism when the data is really flimsy," Makary said.
According to Makary, the FDA is applying basic scientific thresholds to vaccines including its decision not to approve an mRNA-based flu shot that showed no benefit in late-stage trials. He also said the hepatitis B vaccine remains recommended, but that insisting it be given within hours of birth for infants born to hepatitis B–negative mothers reflects an "absolutism" that can undermine trust, and that flexibility is warranted where the science supports it.
Listen to the full conversation by clicking the blue play button above. Makary also appeared on the program Friday to discuss testosterone treatments. You can find that interview here.
The radio interview was produced and edited by Adam Bearne and Lilly Quiroz. The web copy was written by Majd Al-Waheidi and edited by Obed Manuel.
Copyright 2025 NPR
