FDA Commissioner Martin Makary stated that government health organizations must demonstrate increased humility and transparency to restore public trust in their health guidance. He indicated that public trust has diminished since the pandemic.
In an interview, Makary addressed a recent FDA memo concerning rare reports of child deaths associated with COVID-19 vaccinations. He clarified that the information was not new but had not been publicly disclosed. Makary asserted that officials did not adequately communicate how risks varied based on age and pre-existing health conditions, despite the vaccines saving lives.
He was quoted as saying, "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 further explained that the FDA applies scientific thresholds to vaccines. As an example, he cited the decision not to approve an mRNA-based flu shot that showed no benefit in late-stage trials. Regarding the hepatitis B vaccine, Makary stated it remains recommended. However, he contended that mandating its administration within hours of birth for infants born to hepatitis B-negative mothers represents an "absolutism" that can undermine trust. He concluded that flexibility is justified where scientific evidence supports it.