FDA Commissioner Defends Vaccine Stance, Transparency Push
FDA commissioner Marty Makary sought to position himself as a supporter of vaccines while defending recent agency actions that have drawn scrutiny, including an internal memo on child deaths following Covid-19 vaccination and changes to hepatitis B vaccine recommendations for infants.
In an interview with NPR, Makary said FDA has a “moral obligation” to disclose safety data it possesses, even when adverse events are rare. The agency recently produced an internal memo noting reports of roughly 10 child deaths following Covid-19 vaccination, cases Makary said were reviewed by independent physicians who identified a possible link.
Makary stressed that such risks have been publicly documented for years, citing reports of myocarditis following Covid-19 vaccination, including cases published in the New England Journal of Medicine. He emphasized that the complication is rare and that Covid-19 vaccines “saved many lives,” calling their development a public health success.
At the same time, Makary said the pandemic response failed to adequately account for what he described as a stark risk differential between older adults with comorbidities and young, healthy children. He said making internal safety data public was necessary to address that imbalance and rebuild credibility.
Makary rejected the idea that FDA is moving to impose unusually high evidentiary standards on vaccines. Instead, he said the agency is applying the same scientific principles used for other drugs, including reliance on randomized, Phase 3 clinical trial data.
As an example, Makary pointed to a new mRNA-based influenza vaccine that failed to demonstrate benefit in a Phase 3 trial in older adults, saying FDA declined to advance approval. While expressing support for mRNA technology, Makary said the agency would not approve products that fail to show efficacy.
He added that FDA remains interested in next-generation approaches, including the development of a “universal” flu vaccine that could provide long-lasting protection against multiple influenza strains, noting that the effectiveness of current seasonal flu vaccines varies widely year to year.
Makary also addressed controversy surrounding changes to hepatitis B vaccine recommendations for newborns, which followed the dismissal of an advisory committee and the appointment of new members earlier this year under HHS secretary Robert F. Kennedy Jr. Makary said the policy shift has been mischaracterized as opposition to hepatitis B vaccination. Instead, he described it as an effort to introduce flexibility for infants born to hepatitis B–negative mothers, allowing vaccination to occur later rather than within hours of birth when the science supports delay.
He said the recommendation remains unchanged for higher-risk cases, including infants born to hepatitis B–positive mothers, who should receive the vaccine immediately after birth. “We live in a new era of very partisan news coverage and the echo chambers of social media,” Makary said, arguing that public debate has lost “medical nuance.”
Asked about declining trust in federal health agencies, Makary acknowledged a sharp erosion in confidence, citing a drop in public trust from 71% to 40% over the past four years. He attributed much of that decline to pandemic-era decisions he characterized as overly rigid, including prolonged school closures and masking requirements for young children, which he said were not supported by strong evidence.
Makary said rebuilding trust will require humility from public health leaders and a willingness to acknowledge uncertainty when the data are limited. “Sometimes, as a doctor at the bedside, the right answer to a patient’s question is, ‘I don’t know, but I’ll try to find out,’” he said.