FDA Commissioner Martin Makary has stated the need for government health organizations to demonstrate increased humility and transparency to rebuild public trust in health guidance, indicating that confidence has diminished since the pandemic. Makary addressed communication practices regarding COVID-19 vaccinations and discussed the application of scientific thresholds to vaccine recommendations, citing examples such as an mRNA-based flu shot and the hepatitis B vaccine.
Call for Humility and Transparency
Commissioner Makary emphasized that government health organizations must exhibit greater humility and transparency to restore public trust. He noted that public confidence in health guidance has decreased since the pandemic.
COVID-19 Vaccination Communication
Makary specifically addressed an FDA memo that included reports of rare child deaths associated with COVID-19 vaccinations. He clarified that this information was not newly discovered but had not been publicly disseminated. Makary stated that officials did not clearly communicate how risks varied based on age and underlying health conditions, despite the vaccines' role in saving lives.
He was quoted as stating, "The most dangerous thing you can do in medicine is to put out a recommendation with such absolutism when the data is really flimsy."
Application of Scientific Thresholds and Vaccine Recommendations
Makary explained that the FDA applies scientific thresholds in its evaluation of vaccines. As an example, he cited the decision not to approve an mRNA-based flu shot after it showed no benefit in late-stage trials.
Regarding the hepatitis B vaccine, Makary confirmed it remains a recommended vaccination. However, he described the requirement to administer it within hours of birth to infants of hepatitis B-negative mothers as an instance of "absolutism" that he contended could undermine public trust. He concluded that flexibility is justified where scientific evidence supports it.