Did the FDA confirm a link between COVID-19 vaccines and child deaths?

The FDA Commissioner mentioned rare reports of child deaths linked to COVID-19 vaccines, emphasizing the need for clearer communication about risks and benefits.

Why is FDA Commissioner Martin Makary concerned about public trust?

Makary believes government health guidance has lacked transparency and applied recommendations with undue absolutism, eroding public trust.

What examples did Makary give regarding health guidance?

He cited the FDA's decision on an mRNA flu shot and the rigid timing of the hepatitis B vaccine for newborns as areas needing more flexibility.

Home / Health / FDA Chief: Trust Eroded by Absolute Health Guidance

FDA Chief: Trust Eroded by Absolute Health Guidance

16 Dec

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Summary

FDA Commissioner criticized government's lack of transparency.
Rare reports of child deaths linked to COVID vaccines revealed.
Concerns raised over absolute recommendations despite flimsy data.

FDA Chief: Trust Eroded by Absolute Health Guidance

FDA Commissioner Martin Makary has called for greater governmental humility and transparency to restore public trust in health guidance, which he feels has significantly diminished since the pandemic. He pointed to a recent FDA memo that, while not releasing new information, cited rare reports of child deaths associated with COVID-19 vaccines.

Makary expressed concern that officials failed to adequately communicate how risks associated with vaccines varied across different age groups and individuals with underlying health conditions. He argued that issuing recommendations with absolute certainty, especially when the supporting data is not extensive, can be detrimental to public confidence.

Furthermore, Makary noted the FDA's application of scientific thresholds, such as not approving an mRNA flu shot due to a lack of benefit in trials. He also suggested that the rigid recommendation for the hepatitis B vaccine for infants born to negative mothers, given within hours of birth, exemplifies an "absolutism" that can undermine trust, advocating for more flexibility where science permits.