Childhood vaccine recommendations need clear federal data

HHS announced changes to the childhood immunization schedule and described its review as "exhaustive"; a commentary says the public materials lack key data and analyses — including epidemiology, real-world effectiveness and safety, risk-benefit assessments, modeling, implementation analysis, and evidence of public input — needed to assess likely impacts.

The Department of Health and Human Services announced changes to the long-standing childhood immunization schedule and described the review behind those changes as "exhaustive." A recent commentary questions the public materials released with that announcement and reports that they do not include several types of evidence typically presented when vaccine recommendations are revised. The commentary lists missing elements such as epidemiologic data, real-world effectiveness and safety information, explicit risk-benefit assessments, modeling of likely outcomes, implementation considerations, and documentation of public and clinical input. Key points: - The article notes HHS announced changes to the childhood immunization schedule and characterized its own review as "exhaustive." - The commentary reports that the public documents did not provide epidemiologic estimates, post-licensure safety summaries, real-world effectiveness and impact data, explicit risk-benefit analyses, or modelled projections of likely effects on disease, hospitalizations, or deaths. - The commentary also highlights an absence of implementation analysis and structured public or clinical input, and it states that clear estimates of likely impacts are not provided; next steps are undetermined. Summary: The commentary argues that the materials released with the federal announcement do not include the customary evidence and analyses needed to evaluate how changes to vaccine recommendations might affect children and communities. Undetermined at this time.