We’re pausing our “Fast Facts” series this month to address a timely and important topic: shared clinical decision-making (SCDM). This recommendation category has gained renewed attention following the changes to COVID-19 vaccine guidance for children, shifting from a universal recommendation to administration based on shared clinical decision-making. Find out about the history and intent of this type of recommendation and find answers to your questions about SCDM.
Evolution of vaccine recommendations
Childhood vaccine recommendations in the U.S. have existed since at least the late 1930s; however, the first schedule jointly published by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) appeared in the Morbidity and Mortality Weekly Report (MMWR) in 1995. The goal of this unified schedule was to resolve discrepancies between vaccine recommendations from different professional organizations to standardize and simplify the approach to vaccinations for both healthcare providers and families. This first schedule included vaccines for hepatitis B, diphtheria-tetanus-pertussis (DTP), Haemophilus influenzae type b (Hib), poliovirus, and measles-mumps-rubella (MMR). It was largely black and white, with flexibility in timing denoted in gray.
Today’s schedule is more complex, resembling a multicolored roadmap. It incorporates new vaccines, subgroup-specific guidance (e.g., catch-up schedules), and reflects evolving evidence and risk stratification.
The immunization schedule helps clinicians implement FDA-approved products. A routine recommendation, shown in yellow on the schedule, is indicated for all individuals in an age group. Recommendations for high-risk groups are denoted in purple. One color that appears infrequently — but is increasingly discussed — is light blue, the color representing shared clinical decision-making (SCDM). First applied in 2019, this type of recommendation was added for immunizations where the benefits of a vaccine vary based on individual clinical circumstances, but for which a populational benefit was less clear.
Providing vaccine recommendations in these different categories not only guides providers — it also guides insurance companies. For children, the Vaccines for Children (VFC) program is designed to ensure payment for all vaccines on the childhood immunization schedule, including those that are recommended with SCDM. For adults, most private insurance plans pay for routinely recommended vaccines as well as those with SCDM, under Affordable Care Act (ACA) regulations. Medicare Part B, Medicaid, and military insurance (Tricare) also look to the schedule for coverage determinations.
What does an SCDM recommendation mean?
When vaccine recommendations are written by ACIP, the committee uses a framework called “Evidence to Recommendation” (EtR). The EtR framework reviews the public health aspects of a disease, benefits and harms of vaccination, certainty of the evidence, values and preferences, resource use, feasibility, acceptability and equity. After integrating these perspectives, one of three policy-related choices must be chosen: routine, SCDM or no recommendation. For example, when the ACIP considered expanding HPV vaccine use to adults between 27 to 45 years of age, the EtR demonstrated uncertainties related to the public health problem and acceptability in this age group, variable individual benefits, and high costs associated with use of resources if the recommendation was routine. For these reasons, an SCDM recommendation was made.
From a clinical perspective, how is an SCDM recommendation different from routine recommendations?
At the heart of SCDM is the idea that some individuals can benefit from receipt of the vaccine, so a collaborative discussion between the provider and patient can inform whether the vaccination is appropriate and acceptable to that individual. Importantly, SCDM recommendations are not related to any concerns about vaccine safety. In some cases, such as for meningococcal B, data related to vaccine effectiveness may be limited. Due to these data limitations at the time of the recommendation, the relative societal cost per case prevented, and the low number of cases, an SCDM recommendation was implemented. However, rates of meningococcal disease increase from adolescence to young adulthood, meningococcal B infections occur in this age group, and certain activities increase the risk for exposure, so individuals in this age group could reasonably benefit from receipt of this vaccine.
Is SCDM the same as informed consent?
No. It’s important to distinguish between shared clinical decision-making as part of a clinical recommendation framework and informed consent at the point of care. Informed consent is a legal and ethical obligation, regardless of the type of recommendation. Patients must receive information about risks, benefits and alternatives of any health intervention, including vaccination, and they must voluntarily agree to proceed. Informed consent conversations occur between providers and patients or guardians before every vaccine administration. In fact, the Vaccine Information Statement (VIS) required to be given prior to receipt of any vaccination aims to inform patients and families about the risks and benefits of vaccines. VISs are required by law.
Recently, statements about SCDM have suggested that this type of recommendation improves the provider-patient relationship and returns informed consent to the patient, so it is important to understand that SCDM is a type of recommendation rather than an approach to individual healthcare.
What has been the experience with the SCDM recommendation?
SCDM recommendations represent the intersection of healthcare and policymaking, but that nuance has not been well communicated, leaving providers to different interpretations of how to manage them. The results have been diverse and, often, suboptimal when it comes to vaccine uptake.
Providers have identified several challenges, including:
- Lack of time and resources that are not accounted for in current care models, particularly in settings such as pharmacies where a patient’s full medical history is not available, making counseling between the pharmacist and patient incomplete.
- Related to this, lack of reimbursement for counseling sessions.
- Lack of access to a consistent primary care provider, limiting opportunities for extended or ongoing conversations.
- Limitations regarding how SCDM are managed in electronic health records.
- Uncertainties around demand, making it difficult for some providers to stock vaccines recommended by SCDM.
- Lack of knowledge by the physician about data relevant to disease prevalence, vaccine safety, and vaccine efficacy necessary to help patients make an informed decision.
Which vaccines currently have an SCDM recommendation?
As of the April 2025 ACIP meeting, SCDM recommendations accompanied the following vaccines and subgroups:
- HPV vaccine for adults ages 27 to 45.
- Meningococcal B (MenB) vaccine for those 16 to 23 years of age.
- Hepatitis B vaccine in adults 60 years of age and older with diabetes mellitus.
- Pneumococcal conjugate vaccine (PCV20/PCV21) in a subgroup of adults 65 years of age and older. Specifically, if the individual previously received both PCV13 and PPSV23 and their dose of PPSV23 was received when they were at least 65 years of age, the receipt of an additional dose of PCV20 or PCV21 at least five years after the previous pneumococcal vaccine should be determined based on SCDM.
Two of these vaccines (MenB and hepatitis B) had recommendations categorized as the predecessor to SCDM, called “category B” recommendations. Category B was applied to previously known “permissive” recommendations and relied on the point-of-care interaction to determine whether to vaccinate. The language around category A (previously “universal” recommendations) and category B recommendations was more focused on whether the recommendation applied to all people in an age- or risk-based group as opposed to the language around SCDM, which focuses more on individual or populational benefits. The category B framework caused confusion among clinicians and the public, including questions around reimbursement and inconsistent clinical use, so this language was retired in 2018.
What about the SCDM recommendation for COVID-19 vaccination?
In May 2025, COVID-19 vaccination for children shifted from a universal recommendation to one of SCDM following an announcement from the Secretary of Health and Human Services (HHS). This change was notable for a couple of reasons:
Process
Changes to the immunization schedule are informed by vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP) and accepted by the CDC director on behalf of the HHS Secretary. However, in this case, the change was made at the behest of the Secretary without input from the CDC or its advisory committee.
Evidence
In making the change to COVID-19 vaccine recommendations, the Secretary did not provide the evidence which informed this decision, so providers and public health officials must rely on existing data, which supports routine use in specific pediatric groups, including:
- Infants < 12 months, who remain at high risk for hospitalization
- Previously unvaccinated children, even if they have had infection, as receipt of a primary series strengthens immune responses beyond natural infection to reduce hospitalizations and death
- Immune-compromised children, who are at increased risk for severe infection
The good news is that while historically SCDM recommendations have had challenges, this updated recommendation still enables children to be vaccinated if providers and families determine that is how they wish to proceed. However, it will be important to have these conversations to ensure that families are making decisions informed by the data.
Wrap-up
Understanding the intention of SCDM recommendations provides context for healthcare providers who are discussing vaccines with these types of recommendations with families. Patients and families should be counseled about the distinction between an SCDM recommendations and informed consent to clarify the mixed messaging that they may encounter on social media, in the news, or during conversations with friends and family. At the end of the day, SCDM offers a way for individuals who can benefit to get vaccines that might otherwise not be available to the specified group of patients.
Resources
ACIP Shared Clinical Decision-Making Recommendations
Job Aids
- Meningococcal B Vaccination
- HPV Vaccination for Adults Aged 27-45 Years
- PCV20 or PCV21 Vaccination for Adults 65 Years or Older
Contributed by: Lori Handy, MD, MSCE , Charlotte A. Moser, MS, Paul A. Offit, MD
We’re pausing our “Fast Facts” series this month to address a timely and important topic: shared clinical decision-making (SCDM). This recommendation category has gained renewed attention following the changes to COVID-19 vaccine guidance for children, shifting from a universal recommendation to administration based on shared clinical decision-making. Find out about the history and intent of this type of recommendation and find answers to your questions about SCDM.
Evolution of vaccine recommendations
Childhood vaccine recommendations in the U.S. have existed since at least the late 1930s; however, the first schedule jointly published by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) appeared in the Morbidity and Mortality Weekly Report (MMWR) in 1995. The goal of this unified schedule was to resolve discrepancies between vaccine recommendations from different professional organizations to standardize and simplify the approach to vaccinations for both healthcare providers and families. This first schedule included vaccines for hepatitis B, diphtheria-tetanus-pertussis (DTP), Haemophilus influenzae type b (Hib), poliovirus, and measles-mumps-rubella (MMR). It was largely black and white, with flexibility in timing denoted in gray.
Today’s schedule is more complex, resembling a multicolored roadmap. It incorporates new vaccines, subgroup-specific guidance (e.g., catch-up schedules), and reflects evolving evidence and risk stratification.
The immunization schedule helps clinicians implement FDA-approved products. A routine recommendation, shown in yellow on the schedule, is indicated for all individuals in an age group. Recommendations for high-risk groups are denoted in purple. One color that appears infrequently — but is increasingly discussed — is light blue, the color representing shared clinical decision-making (SCDM). First applied in 2019, this type of recommendation was added for immunizations where the benefits of a vaccine vary based on individual clinical circumstances, but for which a populational benefit was less clear.
Providing vaccine recommendations in these different categories not only guides providers — it also guides insurance companies. For children, the Vaccines for Children (VFC) program is designed to ensure payment for all vaccines on the childhood immunization schedule, including those that are recommended with SCDM. For adults, most private insurance plans pay for routinely recommended vaccines as well as those with SCDM, under Affordable Care Act (ACA) regulations. Medicare Part B, Medicaid, and military insurance (Tricare) also look to the schedule for coverage determinations.
What does an SCDM recommendation mean?
When vaccine recommendations are written by ACIP, the committee uses a framework called “Evidence to Recommendation” (EtR). The EtR framework reviews the public health aspects of a disease, benefits and harms of vaccination, certainty of the evidence, values and preferences, resource use, feasibility, acceptability and equity. After integrating these perspectives, one of three policy-related choices must be chosen: routine, SCDM or no recommendation. For example, when the ACIP considered expanding HPV vaccine use to adults between 27 to 45 years of age, the EtR demonstrated uncertainties related to the public health problem and acceptability in this age group, variable individual benefits, and high costs associated with use of resources if the recommendation was routine. For these reasons, an SCDM recommendation was made.
From a clinical perspective, how is an SCDM recommendation different from routine recommendations?
At the heart of SCDM is the idea that some individuals can benefit from receipt of the vaccine, so a collaborative discussion between the provider and patient can inform whether the vaccination is appropriate and acceptable to that individual. Importantly, SCDM recommendations are not related to any concerns about vaccine safety. In some cases, such as for meningococcal B, data related to vaccine effectiveness may be limited. Due to these data limitations at the time of the recommendation, the relative societal cost per case prevented, and the low number of cases, an SCDM recommendation was implemented. However, rates of meningococcal disease increase from adolescence to young adulthood, meningococcal B infections occur in this age group, and certain activities increase the risk for exposure, so individuals in this age group could reasonably benefit from receipt of this vaccine.
Is SCDM the same as informed consent?
No. It’s important to distinguish between shared clinical decision-making as part of a clinical recommendation framework and informed consent at the point of care. Informed consent is a legal and ethical obligation, regardless of the type of recommendation. Patients must receive information about risks, benefits and alternatives of any health intervention, including vaccination, and they must voluntarily agree to proceed. Informed consent conversations occur between providers and patients or guardians before every vaccine administration. In fact, the Vaccine Information Statement (VIS) required to be given prior to receipt of any vaccination aims to inform patients and families about the risks and benefits of vaccines. VISs are required by law.
Recently, statements about SCDM have suggested that this type of recommendation improves the provider-patient relationship and returns informed consent to the patient, so it is important to understand that SCDM is a type of recommendation rather than an approach to individual healthcare.
What has been the experience with the SCDM recommendation?
SCDM recommendations represent the intersection of healthcare and policymaking, but that nuance has not been well communicated, leaving providers to different interpretations of how to manage them. The results have been diverse and, often, suboptimal when it comes to vaccine uptake.
Providers have identified several challenges, including:
- Lack of time and resources that are not accounted for in current care models, particularly in settings such as pharmacies where a patient’s full medical history is not available, making counseling between the pharmacist and patient incomplete.
- Related to this, lack of reimbursement for counseling sessions.
- Lack of access to a consistent primary care provider, limiting opportunities for extended or ongoing conversations.
- Limitations regarding how SCDM are managed in electronic health records.
- Uncertainties around demand, making it difficult for some providers to stock vaccines recommended by SCDM.
- Lack of knowledge by the physician about data relevant to disease prevalence, vaccine safety, and vaccine efficacy necessary to help patients make an informed decision.
Which vaccines currently have an SCDM recommendation?
As of the April 2025 ACIP meeting, SCDM recommendations accompanied the following vaccines and subgroups:
- HPV vaccine for adults ages 27 to 45.
- Meningococcal B (MenB) vaccine for those 16 to 23 years of age.
- Hepatitis B vaccine in adults 60 years of age and older with diabetes mellitus.
- Pneumococcal conjugate vaccine (PCV20/PCV21) in a subgroup of adults 65 years of age and older. Specifically, if the individual previously received both PCV13 and PPSV23 and their dose of PPSV23 was received when they were at least 65 years of age, the receipt of an additional dose of PCV20 or PCV21 at least five years after the previous pneumococcal vaccine should be determined based on SCDM.
Two of these vaccines (MenB and hepatitis B) had recommendations categorized as the predecessor to SCDM, called “category B” recommendations. Category B was applied to previously known “permissive” recommendations and relied on the point-of-care interaction to determine whether to vaccinate. The language around category A (previously “universal” recommendations) and category B recommendations was more focused on whether the recommendation applied to all people in an age- or risk-based group as opposed to the language around SCDM, which focuses more on individual or populational benefits. The category B framework caused confusion among clinicians and the public, including questions around reimbursement and inconsistent clinical use, so this language was retired in 2018.
What about the SCDM recommendation for COVID-19 vaccination?
In May 2025, COVID-19 vaccination for children shifted from a universal recommendation to one of SCDM following an announcement from the Secretary of Health and Human Services (HHS). This change was notable for a couple of reasons:
Process
Changes to the immunization schedule are informed by vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP) and accepted by the CDC director on behalf of the HHS Secretary. However, in this case, the change was made at the behest of the Secretary without input from the CDC or its advisory committee.
Evidence
In making the change to COVID-19 vaccine recommendations, the Secretary did not provide the evidence which informed this decision, so providers and public health officials must rely on existing data, which supports routine use in specific pediatric groups, including:
- Infants < 12 months, who remain at high risk for hospitalization
- Previously unvaccinated children, even if they have had infection, as receipt of a primary series strengthens immune responses beyond natural infection to reduce hospitalizations and death
- Immune-compromised children, who are at increased risk for severe infection
The good news is that while historically SCDM recommendations have had challenges, this updated recommendation still enables children to be vaccinated if providers and families determine that is how they wish to proceed. However, it will be important to have these conversations to ensure that families are making decisions informed by the data.
Wrap-up
Understanding the intention of SCDM recommendations provides context for healthcare providers who are discussing vaccines with these types of recommendations with families. Patients and families should be counseled about the distinction between an SCDM recommendations and informed consent to clarify the mixed messaging that they may encounter on social media, in the news, or during conversations with friends and family. At the end of the day, SCDM offers a way for individuals who can benefit to get vaccines that might otherwise not be available to the specified group of patients.
Resources
ACIP Shared Clinical Decision-Making Recommendations
Job Aids
- Meningococcal B Vaccination
- HPV Vaccination for Adults Aged 27-45 Years
- PCV20 or PCV21 Vaccination for Adults 65 Years or Older
Contributed by: Lori Handy, MD, MSCE , Charlotte A. Moser, MS, Paul A. Offit, MD