I agree with Drs. Scott Gottlieb and Mark McClellan that the FDA is capable of performing a competent review of Covid-19 vaccines, but they fail to mention a workaround in federal law (U.S. Code, Title 21, Chapter 9) that could obviate the need for FDA approval or input ("You Can Trust the FDA's Vaccine Process," op-ed, Sept. 21). It specifies that the secretary of Health and Human Services may issue an authorization for emergency use of a drug or vaccine if "after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention . . . the Secretary concludes (1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective."
Note that the HHS secretary is only required to consult with, but not obtain agreement from, the three subordinates specified in the law. Moreover, none of the officials entrusted with making the decision appears to have any experience with the critical nonclinical aspects of vaccine production, although control of and consistency in manufacturing are essential to ensuring the safety and efficacy of vaccines. For example, can the manufacturer ensure that every batch meets the standards for purity, potency and sterility, and that the facility passed inspection?
An approval that circumvents the FDA would fan the passions of the antivaccine movement and undermine public confidence in Covid-19 vaccines; more important, it could endanger vaccine recipients.
Henry I. Miller, M.D.
Redwood City, Calif.