The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
Health Secretary Robert F. Kennedy Jr. is once again taking aim at routine immunization in the U.S., challenging the current scheme the government uses to classify its vaccine recommendations.
Under CDC guidelines, the decision to use vaccines aligns with one of three categories, according to a Request for Information (RFI) document posted Friday on the Federal Register. Shots that are meant for universal use in a certain age group—barring contraindications—fall under routine recommendations, while others are given based on level of risk depending on medical, behavioral, occupational or other factors.
A third group of vaccines require shared clinical decision-making (SCDM), according to Kennedy’s RFI, in which doctors confer with the patients themselves or with their parents or guardians. The health secretary takes issue with this category specifically, noting that it could suggest that the other categories don’t involve input from the parents and their families.
“Do the current categories unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations?” he asked in the RFI.
Friday’s RFI is intended to support President Donald Trump’s Aug. 10 executive order directing Kennedy and the health department to break up the standard measles, mumps and rubella vaccine into three separate shots given across separate medical visits. Healthcare providers have pushed back on Trump’s order, and pharma companies have said that it would take years to implement this change.
Kennedy is now asking for feedback from stakeholders—clinicians, researchers, vaccine manufacturers and even patients, parents and faith communities—on the current classifications for vaccine recommendations, and whether new categories are needed.
Some new or modified categories include “recommended, but not during infancy,” and “shared clinical decision-making with qualification,” Kennedy offered.
Aside from taking a second look at the vaccination categories, the RFI also sought input on what types of evidence the health department should take into consideration when setting immunization guidelines, particularly when randomized controlled study data are lacking.
“The durability of any vaccine recommendation framework depends on the public’s trust in the process that produces it,” Kennedy wrote, contending that following the COVID-19 pandemic, with its broad vaccination mandates, “public trust in Federal public health agencies declined measurably.” The HHS leader is additionally soliciting comments for communication practices that the department can put in place alongside its vaccine recommendations.
