FDA Commissioner Martin Makary has commented on the growing public mistrust of government health advice, asserting that government entities must exhibit greater humility and transparency to rebuild confidence, which he indicated has significantly eroded since the pandemic.
Makary addressed a recent dispute concerning an FDA memo that included reports of rare child deaths linked to COVID-19 vaccinations. He stated that this information was not newly discovered but had not been publicly disseminated. He further argued that officials did not adequately communicate how risks differed based on age and underlying health conditions, despite the vaccines saving numerous lives. Makary conveyed that making absolute recommendations based on "flimsy" data is a critical error in medicine.
The FDA, under Makary's leadership, is applying fundamental scientific thresholds to vaccine evaluations. This includes a decision not to approve an mRNA-based flu shot due to its failure to demonstrate benefit in late-stage trials. Regarding the hepatitis B vaccine, Makary stated it remains recommended. However, he described the requirement to administer it within hours of birth to infants of hepatitis B-negative mothers as an example of "absolutism" that could diminish trust, advocating for flexibility where scientific evidence supports it.