One common misconception about vaccines is that a small number of people have outsized roles in determining vaccine availability and use in the U.S., but reality demonstrates nuance and a series of decision-making levels on the path from a vaccine on the shelf to a vaccine in an arm. So, this month, we thought we would describe where responsibilities lie when it comes to the U.S. vaccine program, particularly since understanding where each branch of government impacts vaccine policy can help us know where to watch for change and consider advocacy.
Federal government
The two main agencies of federal government that influence vaccine policy are the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
FDA
The FDA approves new vaccines and regulates all of them (new and existing) by reviewing studies, issuing indications, and enforcing quality standards. After production, FDA ensures that pharmaceutical companies follow “Good Manufacturing Practices” (GMP) — a set of standards that ensure products are made consistently over time and meet quality requirements. These processes ensure that vaccine production across companies meets the same, predetermined standards.
Looking behind the curtain, Congress and the U.S. President both have influence over the FDA. Congress sets the FDA’s budget and the laws under which the FDA operates, while the President appoints the FDA’s leadership. The secretary of the Department of Health and Human Services (HHS), a presidential appointee, has the legal authority to override an FDA rule or approval decision, and the U.S. President typically has a program for review and clearance of agency decisions.
CDC
When it comes to vaccines, the CDC oversees several aspects at the federal level. Its most visible role is creating recommendations for how vaccines should be used. Vaccine recommendations are made based on guidance from the Advisory Committee on Immunization Practices (ACIP), a group of experts appointed by HHS. While members of the ACIP serve terms of four years, the charter for the advisory committee requires renewal every two years. Renewal of this committee’s charge will next occur in April 2026.
Once vaccines are recommended, the CDC is charged with providing immunization schedules that reflect the guidance. The recommendations and schedules are used by a variety of vaccine stakeholders who implement vaccines at other levels.
More broadly, the CDC has many responsibilities related to maintaining the overall health of the U.S. population. For example, the CDC is charged with:
- Detecting and responding to new and emerging health threats
- Identifying and responding to the leading health problems that cause death and disability
- Using science and technology to prevent disease
- Promoting healthy and safe behaviors, such as exercising, eating healthy food, and refraining from smoking
- Training the public health workforce
- And more
Three examples of how these responsibilities are realized include:
- Mpox: When mpox became a new health threat in the U.S. in 2022, the CDC led the national response by tracking data across the country, providing awareness and education for healthcare providers and public health experts, supporting laboratory testing, outlining vaccine recommendations and developing guidance for the public on healthy behaviors. In this way, CDC develops a unified understanding of a situation for the entire country.
- Measles outbreaks: As we continue to see measles outbreaks, many responses are advanced at the state and local level, but those individuals need an understanding of what is happening at the national level to learn from the experiences of others and to inform their own efforts based on the local situation, particularly since movement across communities and states can quickly cause this infection to become widespread.
- Foodborne illnesses: Recent outbreaks of E.coli caused by contaminated onions and carrots demonstrate the important role of federal responses in these situations. The contaminated onions caused illness in people from at least 14 states and were traced back to McDonald’s. The contaminated carrots were distributed through several popular store chains, leading to cases in 18 states. While the FDA is responsible for food recalls, the CDC assists with the investigation of cases and communication to providers and the public.
State governments
In our federalist government, where power is shared, states also have important responsibilities related to vaccines.
Vaccine-related efforts at the state level include:
- Overseeing and relaying school vaccine requirements
- Investigating and reporting disease outbreaks
- Providing emergency response support
- Communicating with the public
- Implementing state-based vaccine-related programs, including clinics, provider enrollment, outreach and education
They also often serve as a bridge between federal and local governments and bring together state-level stakeholders, including healthcare providers, researchers, non-profits, pharmacies, school nurses and more.
Vaccine requirements are firmly rooted in state responsibilities. While all 50 states have school-entry requirements, the requirements vary across states. Further, they do not necessarily align with CDC recommendations — a point not always realized by the public. Importantly, CDC recommendations typically represent best health practices based on science, but requirements are made in a political climate, so state budgets, social priorities, and the makeup of the legislature shape the laws. In the same vein, the types of and processes for requesting vaccine exemptions also differ by state.
Local government
States may have county, city or municipal health departments. These local departments may be implementing state guidance and regulations. Alternatively, certain local departments represent decentralized public health services, meaning the local department is responsible for all of the needs of the community. Even within a single state, this can lead to a patchwork of policy.
Two examples related to the decision-making that can occur at the local level are instructive:
- Philadelphia, 1991: In 1991, a deadly measles epidemic caused 1,400 cases of measles and 9 deaths, mostly among members of a religious community eschewing vaccination. Officials at the Philadelphia Department of Public Health, realizing their responsibility to ensure that additional children did not get sick or die, sought a court order to vaccinate children in the homes of members of this religious community. The court agreed, and medical providers in the city were able to legally act to protect these children.
- Idaho, 2024: Unfortunately, local health departments can also be forced to discourage, or restrict, vaccination. Recently, council members in Idaho restricted employees at a regional health department from offering COVID-19 vaccines in six counties in the southwestern region of the state, despite the medical director of the health department testifying in support of the vaccine.
These two cases demonstrate the local nature of governance related to vaccine policy and the potential impact of the political environment on decision-making. In the 1990s, children were saved from a deadly disease with local court involvement. In contrast, in 2024, the decision of a regional government board was not based on sound science and will likely result in unnecessary illness and death among the population being served.
Ways to address vaccine policy changes
Vaccine safety and effectiveness are based on science, but as demonstrated, vaccine policy is much more nuanced because it is shaped by political and social forces. As such, when debates over vaccine policies arise, understanding the different roles of federal, state and local government can help explain outcomes and serve to guide advocacy efforts. With that in mind, here are four ways to affect change:
- Education: Different groups communicate with the public in different ways. For example, healthcare providers often have the unique opportunity to develop long-term relationships and have individual conversations with patients. On the other hand, public health officials more often communicate with other stakeholders, such as healthcare providers, or to large portions of a population through news conferences, interviews and media campaigns. Most institutions, whether governmental, private or non-profit, have websites, and some have social media accounts, affording additional ways to provide information about vaccines and vaccine-preventable diseases. Consider how you most often communicate (and are most comfortable communicating), and use that platform to ensure that individuals have their questions answered and are provided with accurate information about vaccines and vaccine policy.
- Public advocacy: There are ways outside of your typical job responsibilities to influence national and local conversations on vaccine policy. Give talks. Write letters. Share with your social media networks. Speak to the media.
- Political advocacy: Contact your elected officials. This can be done independently or through groups whose missions include advocacy. Professional organizations, like the American Academy of Pediatrics (AAP), work with elected leaders to advocate for the health of children, and organizations, like Vaccinate Your Family and the SAFE Communities Coalition, advocate for pro-vaccine, science-based policies. In some cases, local or state immunization coalitions also bring together individuals and organizations to partner and advocate for childhood, adolescent and adult immunizations.
- Legal efforts: If a change in policy does not have sound legal or scientific standing, court systems can also be employed.
Whether or not you decide to be personally involved in the pursuit of change, understanding how the various systems work together provides an important context for interpreting what is happening. For additional information check the “Resources for additional information” section.
Resources for additional information
- A Closer Look: The History and Authority of the FDA
- Vaccine policymaking – Behind the scenes with the ACIP consumer rep
- State vaccine recommendations
- Vaccine exemptions by state
- Viewpoint: The future of vaccine policy in the United States
Contributed by: Lori Handy, MD, MSCE , Charlotte A. Moser, MS, Paul A. Offit, MD
One common misconception about vaccines is that a small number of people have outsized roles in determining vaccine availability and use in the U.S., but reality demonstrates nuance and a series of decision-making levels on the path from a vaccine on the shelf to a vaccine in an arm. So, this month, we thought we would describe where responsibilities lie when it comes to the U.S. vaccine program, particularly since understanding where each branch of government impacts vaccine policy can help us know where to watch for change and consider advocacy.
Federal government
The two main agencies of federal government that influence vaccine policy are the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
FDA
The FDA approves new vaccines and regulates all of them (new and existing) by reviewing studies, issuing indications, and enforcing quality standards. After production, FDA ensures that pharmaceutical companies follow “Good Manufacturing Practices” (GMP) — a set of standards that ensure products are made consistently over time and meet quality requirements. These processes ensure that vaccine production across companies meets the same, predetermined standards.
Looking behind the curtain, Congress and the U.S. President both have influence over the FDA. Congress sets the FDA’s budget and the laws under which the FDA operates, while the President appoints the FDA’s leadership. The secretary of the Department of Health and Human Services (HHS), a presidential appointee, has the legal authority to override an FDA rule or approval decision, and the U.S. President typically has a program for review and clearance of agency decisions.
CDC
When it comes to vaccines, the CDC oversees several aspects at the federal level. Its most visible role is creating recommendations for how vaccines should be used. Vaccine recommendations are made based on guidance from the Advisory Committee on Immunization Practices (ACIP), a group of experts appointed by HHS. While members of the ACIP serve terms of four years, the charter for the advisory committee requires renewal every two years. Renewal of this committee’s charge will next occur in April 2026.
Once vaccines are recommended, the CDC is charged with providing immunization schedules that reflect the guidance. The recommendations and schedules are used by a variety of vaccine stakeholders who implement vaccines at other levels.
More broadly, the CDC has many responsibilities related to maintaining the overall health of the U.S. population. For example, the CDC is charged with:
- Detecting and responding to new and emerging health threats
- Identifying and responding to the leading health problems that cause death and disability
- Using science and technology to prevent disease
- Promoting healthy and safe behaviors, such as exercising, eating healthy food, and refraining from smoking
- Training the public health workforce
- And more
Three examples of how these responsibilities are realized include:
- Mpox: When mpox became a new health threat in the U.S. in 2022, the CDC led the national response by tracking data across the country, providing awareness and education for healthcare providers and public health experts, supporting laboratory testing, outlining vaccine recommendations and developing guidance for the public on healthy behaviors. In this way, CDC develops a unified understanding of a situation for the entire country.
- Measles outbreaks: As we continue to see measles outbreaks, many responses are advanced at the state and local level, but those individuals need an understanding of what is happening at the national level to learn from the experiences of others and to inform their own efforts based on the local situation, particularly since movement across communities and states can quickly cause this infection to become widespread.
- Foodborne illnesses: Recent outbreaks of E.coli caused by contaminated onions and carrots demonstrate the important role of federal responses in these situations. The contaminated onions caused illness in people from at least 14 states and were traced back to McDonald’s. The contaminated carrots were distributed through several popular store chains, leading to cases in 18 states. While the FDA is responsible for food recalls, the CDC assists with the investigation of cases and communication to providers and the public.
State governments
In our federalist government, where power is shared, states also have important responsibilities related to vaccines.
Vaccine-related efforts at the state level include:
- Overseeing and relaying school vaccine requirements
- Investigating and reporting disease outbreaks
- Providing emergency response support
- Communicating with the public
- Implementing state-based vaccine-related programs, including clinics, provider enrollment, outreach and education
They also often serve as a bridge between federal and local governments and bring together state-level stakeholders, including healthcare providers, researchers, non-profits, pharmacies, school nurses and more.
Vaccine requirements are firmly rooted in state responsibilities. While all 50 states have school-entry requirements, the requirements vary across states. Further, they do not necessarily align with CDC recommendations — a point not always realized by the public. Importantly, CDC recommendations typically represent best health practices based on science, but requirements are made in a political climate, so state budgets, social priorities, and the makeup of the legislature shape the laws. In the same vein, the types of and processes for requesting vaccine exemptions also differ by state.
Local government
States may have county, city or municipal health departments. These local departments may be implementing state guidance and regulations. Alternatively, certain local departments represent decentralized public health services, meaning the local department is responsible for all of the needs of the community. Even within a single state, this can lead to a patchwork of policy.
Two examples related to the decision-making that can occur at the local level are instructive:
- Philadelphia, 1991: In 1991, a deadly measles epidemic caused 1,400 cases of measles and 9 deaths, mostly among members of a religious community eschewing vaccination. Officials at the Philadelphia Department of Public Health, realizing their responsibility to ensure that additional children did not get sick or die, sought a court order to vaccinate children in the homes of members of this religious community. The court agreed, and medical providers in the city were able to legally act to protect these children.
- Idaho, 2024: Unfortunately, local health departments can also be forced to discourage, or restrict, vaccination. Recently, council members in Idaho restricted employees at a regional health department from offering COVID-19 vaccines in six counties in the southwestern region of the state, despite the medical director of the health department testifying in support of the vaccine.
These two cases demonstrate the local nature of governance related to vaccine policy and the potential impact of the political environment on decision-making. In the 1990s, children were saved from a deadly disease with local court involvement. In contrast, in 2024, the decision of a regional government board was not based on sound science and will likely result in unnecessary illness and death among the population being served.
Ways to address vaccine policy changes
Vaccine safety and effectiveness are based on science, but as demonstrated, vaccine policy is much more nuanced because it is shaped by political and social forces. As such, when debates over vaccine policies arise, understanding the different roles of federal, state and local government can help explain outcomes and serve to guide advocacy efforts. With that in mind, here are four ways to affect change:
- Education: Different groups communicate with the public in different ways. For example, healthcare providers often have the unique opportunity to develop long-term relationships and have individual conversations with patients. On the other hand, public health officials more often communicate with other stakeholders, such as healthcare providers, or to large portions of a population through news conferences, interviews and media campaigns. Most institutions, whether governmental, private or non-profit, have websites, and some have social media accounts, affording additional ways to provide information about vaccines and vaccine-preventable diseases. Consider how you most often communicate (and are most comfortable communicating), and use that platform to ensure that individuals have their questions answered and are provided with accurate information about vaccines and vaccine policy.
- Public advocacy: There are ways outside of your typical job responsibilities to influence national and local conversations on vaccine policy. Give talks. Write letters. Share with your social media networks. Speak to the media.
- Political advocacy: Contact your elected officials. This can be done independently or through groups whose missions include advocacy. Professional organizations, like the American Academy of Pediatrics (AAP), work with elected leaders to advocate for the health of children, and organizations, like Vaccinate Your Family and the SAFE Communities Coalition, advocate for pro-vaccine, science-based policies. In some cases, local or state immunization coalitions also bring together individuals and organizations to partner and advocate for childhood, adolescent and adult immunizations.
- Legal efforts: If a change in policy does not have sound legal or scientific standing, court systems can also be employed.
Whether or not you decide to be personally involved in the pursuit of change, understanding how the various systems work together provides an important context for interpreting what is happening. For additional information check the “Resources for additional information” section.
Resources for additional information
- A Closer Look: The History and Authority of the FDA
- Vaccine policymaking – Behind the scenes with the ACIP consumer rep
- State vaccine recommendations
- Vaccine exemptions by state
- Viewpoint: The future of vaccine policy in the United States
Contributed by: Lori Handy, MD, MSCE , Charlotte A. Moser, MS, Paul A. Offit, MD