CDC Panel OKs COVID-19 Guidance Shift, Steers Clear of Prescriptions

An advisory panel within the U.S. Centers for Disease Control and Prevention (CDC) on Friday, Sept. 19, made substantive changes to federal COVID-19 guidance by voting unanimously to:

• Scrap a standing federal recommendation that Americans aged 65 and older get a COVID-19 vaccine; and,
• Adopt a recommendation that individuals (or caretakers/guardians for those individuals) talk with a healthcare clinician before getting that vaccination.

While the 12-member Advisory Committee on Immunization Practices (ACIP) decided to remove “universal recommendation” and add a “shared clinical decision-making” consultation layer to the COVID-19 vaccination process, it did not take the more drastic step of requiring a prescription for Americans to receive the immunization. The committee was deadlocked on that measure before committee chair Martin Kulldorff voted “no” to break the 6-6 tie.

The committee also voted to recommend that the CDC “[engage] in an effort to promote more consistent and comprehensive informed consent processes,” including potentially highlighting “risks and uncertainties” around coronavirus vaccines.

The committee’s affirmed recommendation on “shared clinical decision-making” advised that, while vaccinations be based on individual-based decision-making:

• Individuals aged 65 and older make the decision about whether to get a COVID-19 vaccine with a doctor or another healthcare provider; and,
• Individuals younger than age 65 should consult with a healthcare clinician and jointly consider “an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.”

According to published reports, Kulldorff said it was his interpretation that the committee’s recommendation meant that COVID-19 vaccines would still be covered by insurance. Recommendations from agencies such as the CDC have traditionally:

• Determined what vaccines are provided free of charge through the U.S. government;
• Influenced and directed state and local laws around vaccine requirements; and,
• Influenced and directed health insurance companies as to what vaccines to cover.

The recommendations are not final; they now go to CDC Acting Director Jim O’Neill for consideration and approval. O’Neill, a deputy to Health and Human Services Secretary Robert F. Kennedy Jr., has led the agency since the abrupt removal of Susan Monarez in August.

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