Vote #1 “It is the sense of the committee that the CDC engages in an effort to promote more consistent and comprehensive informed consent processes, and as part of that considers adding language accessible to patients and medical providers to describe at least the six risks and uncertainties included in the WG chair presentation.”
Vote #2 “It is the sense of the committee that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccination.”
Vote #3 “It is the sense of the committee that in conversations with patients before COVID-19 vaccination, authorized healthcare providers discuss the risks and benefits of the vaccination for the individual patient. The discussion should consider known risk factors for severe outcomes from COVID-19, such as age, prior infections, immunosuppression, and certain comorbidities identified by the CDC, and include a discussion of the potential benefits and risks of vaccination and related uncertainties, especially those outlined in the vaccine information statement, as part of informed consent.”
Vote #4 “The pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines should be updated as follows:
• Adults 65 and older: Vaccination based on individual-based decision-making*
• Individuals 6 months to 64 years: Vaccination based on individual-based decision-making - with 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.
*Also known as shared clinical decision making.”
Meeting Slides. Image credits: CDC
What You Need To Know
ACIP updated schedules to recommend COVID-19 vaccination for all persons ≥6 months using individual/shared clinical decision-making, prioritizing those at higher risk for severe disease.
The committee requested that CDC standardize and enhance informed-consent materials, including plain-language descriptions of key risks and uncertainties.
Clinicians are encouraged to discuss patient-specific factors (age, prior infection, immunosuppression, CDC-listed comorbidities) and review benefits, risks, and uncertainties before vaccination.
A proposal to require prescriptions for COVID-19 vaccination was not adopted as a barrier to access.
Some Discussion Points From September 19th ACIP Meeting (COVID-19)
Votes and draft language
- Policy frame: Vaccination for all persons 6 months and older under individual or shared clinical decision making, with emphasis that benefit is greatest for patients at increased risk for severe COVID-19.
- Informed consent: Request for CDC to promote more consistent and comprehensive informed consent, including plain-language descriptions of key risks and uncertainties.
- Clinical conversation: Encourage clinicians to discuss patient-specific risk factors (age, prior infection, immunosuppression, CDC-listed comorbidities) and to review benefits, risks, and remaining uncertainties before vaccination.
- Prescription proposal: A “sense of the committee” statement proposed requiring prescriptions for COVID vaccination. Final direction communicated after discussion indicated no prescription requirement.
Epidemiology and coverage
- CDC reported low overall vaccine uptake, highest in older adults and lower in younger groups.
- Hospitalization risk continues to be highest in the very young and the very old.
- CDC presented multiple approaches to classify “with” vs “for” COVID hospitalizations and reported that most admissions are categorized correctly.
Safety discussion
- Myocarditis: Preliminary data were reviewed on post-vaccination myocarditis. Speakers reiterated the need for continued monitoring and noted that SARS-CoV-2 infection also elevates myocarditis risk.
- Cancer assertions: Case reports suggesting vaccination could trigger cancer were discussed. Presenters and commenters noted that case reports do not establish causality and that stronger study designs are needed to inform policy.
Process and communication
- Members and liaisons called for transparent posting of vote language, consistent use of the evidence-to-recommendation framework, and clear separation of hypothesis-generating signals from data suitable for recommendations.
- The committee requested clear, accessible VIS and consent materials for clinicians and patients.
Reference
CDC. ACIP Meeting Information. Accessed September 19, 2025. https://www.cdc.gov/acip/meetings/index.html
