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Feature Article: Understanding the Seismic Shift in Maintaining Access to Vaccines in the U.S.
Find out how vaccines progressed from clinical trials to licensure and recommendations prior to 2025. Learn how important parts of the process have changed since 2025 and the novel approaches attempting to address the gaps. Vaccines have been in the news a lot. We hear something from federal officials, even the U.S. president; then we hear other stuff from doctors and scientists. So, what is happening and how can you know what to believe? Let’s dive in.What used to happen? View larger image. Historically, for better or worse, the public didn’t hear a lot about vaccines. They went to their doctor who told them which vaccines were recommended or required, and most often people followed their doctor’s advice. Unfortunately, that left a huge gap in understanding about everything that happened to get to the point of the doctor recommending the vaccine. There were three separate parts of the process.Vaccine availability: FDAWhen a company had a candidate vaccine they wanted to make available, they worked with the Food and Drug Administration (FDA) — often for years — to study that vaccine in a series of clinical trials of increasing size. The FDA had input into how those trials were designed and conducted, and they reviewed all the data before the vaccine was licensed, meaning before it could be available to the public. This work involved thousands of people, including employees of the company, healthcare providers and scientists assisting with the clinical trials, and government employees, including a special group of expert volunteers who reviewed the data on a committee known as the Vaccines and Regulated Biological Products Advisory Committee (VRBPAC). Vaccine access: CDCAs the vaccine was progressing through the FDA’s licensure process, a second group of expert volunteers, called the Advisory Committee on Immunization Practices (ACIP), worked with the Centers for Disease Control and Prevention (CDC) to understand: Characteristics of the pathogen causing the disease Who the disease affectedHow the vaccine worked (and how well it worked) How safe the vaccine was What healthcare providers and the public thought about the potential for using the vaccine if it was licensed by the FDAThese details came from everywhere available — no stone was left unturned. Commonly, data were generated by: State and federal health departmentsHealth insurance companiesUniversity scientistsHealthcare professionals and medical systems Pharmaceutical companiesGlobal entitiesLikewise, the evaluation of this information was done by dozens of people, not only voting members of the ACIP but also people representing professional organizations (e.g., organizations representing pediatricians, family physicians, nurses, infectious disease doctors, and more) and state and local public health departments, as well as scientists who studied the pathogen and government officials. The ACIP’s work occurred monthly over the one to two years before the vaccine was licensed. The reason for this work during a time when it was unclear whether the vaccine would ever be a product was because if the vaccine was licensed, the ACIP was required to provide recommendations and clinical guidance for its use at their next public meeting. The ACIP understood that what they decided informed (1) who could get a vaccine and (2) whether that vaccine would be covered by insurance and public payment programs, like the Vaccines for Children (VFC) program. In short, the ACIP’s recommendations had the greatest impact on access to vaccines. Two other notes about ACIP recommendations:In addition to recommending vaccines, the ACIP and CDC oversaw details of how the vaccine was used, meaning who within a given population could get the vaccine, who should not, how the vaccine should be administered in consideration of other vaccines and more. For this reason, the ACIP and CDC also oversaw the immunization schedule.For families, the ACIP’s work was often the least known, but it was arguably the most important. Vaccine laws: statesACIP recommendations are not laws. Vaccine laws are often referred to as requirements or mandates. A common misconception is that ACIP recommendations translated directly into requirements or vaccine mandates. However, vaccine laws are made at the state level, and different states make different vaccine requirements.In sumSimply put, the moment when a doctor offers a patient a vaccine is only possible if the vaccine is available and accessible, and those two aspects are informed by years of work involving thousands of people studying an exhaustive amount of data generated around the world. So, what has changed?Since early 2025, important parts of the process have changed. While changes have occurred across the federal government, the biggest effects on the vaccine process to date have been at the access level. While most vaccines can still be received by the people who want them, federal efforts have eroded the CDC’s processes in several ways:The ACIP members were removed and replaced with people who generally do not support vaccines, using a process that was flipped on its head. While historically ACIP members applied and were vetted by the CDC before being approved by the secretary of health and human services, the revised approach is top down with the secretary naming people independent of CDC vetting. The historical process took about two years, whereas the revised process seems to take days or weeks.Many CDC staff have been removed or reassigned, so they are no longer doing the work related to vaccines.Changes to the immunization schedule have removed the CDC from the process and have at times come from the secretary, the FDA, even the U.S. president. These changes have not been based on new data, nor have they resulted from the comprehensive process and data review used historically.As a result of the way many of these changes have occurred, lawsuits have been filed, and at this time, the changes have been put on hold by the courts because of concerns that laws were not followed in making them. Unfortunately, the lack of resolution of these cases has meant that those in power have sought other methods for making additional changes. Collectively, these changes have resulted in disease surveillance gaps, vaccine access delays, competing narratives, eroded trust, and widespread frustration and confusion. To find more details about the changes, check out Unbreaking’s “Infectious Disease Control & Prevention” timeline.The novel approach that is developing View larger image. Importantly, what hasn’t changed is that there are still thousands of people who care about keeping vaccines safe and accessible. Many are those same people whose work fell into the public knowledge gap and whose names weren’t known. Despite limited resources and federal gaslighting, these people have come together to develop a novel system. It doesn’t fill all the gaps left by the federal changes, but these efforts are both unique in history and heroic in measure.Data review: Vaccine Integrity ProjectThe Vaccine Integrity Project (VIP), a group based at the University of Minnesota, has taken the lead in ensuring that science remains at the heart of any vaccine recommendations. Since 2025, VIP has convened separate, independent groups of experts to review existing and new data about specific, relevant vaccine topics, such as fall respiratory viral vaccines, hepatitis B birth dose, and HPV vaccines, among others. In each case, they prepare extensive reports that can be used by others to develop vaccine recommendations.Making recommendations: Professional societiesThe evidence reviews prepared by VIP are used by specific groups of professional societies, who themselves convene groups of experts to study and discuss the evidence and make informed recommendations about the use of vaccines for the patient populations they see:American Academy of Pediatrics (AAP) develops vaccine recommendations for those up to 18 years of age.American Academy of Family Physicians (AAFP) develops vaccine recommendations for those 19 years of age and older.American College of Obstetricians and Gynecologists (ACOG) develops vaccine recommendations for those who are pregnant or planning to become pregnant.Infectious Diseases Society of America (IDSA) develops vaccine recommendations for those who are immune compromised. Two points are important:Some of the groups have overlaps in the patients they treat. Historically, considerations related to these overlaps occurred in the context of the ACIP process because everyone was involved in that process. Now, these overlaps rely on the groups coming together independently or they could result in different approaches, making clinical care and decision making more complex for families and providers.All these groups were involved in the historic process, and all supported the CDC’s immunization schedule resulting from that process. The last schedules for both children and adults resulting from the historic process were published in January 2025. For most vaccines, those recommendations remain on the schedules now supported by these groups.Find the recommendations as well as the 2025 schedule and the current schedules using links from the “Locating the Latest Science-based Vaccine Recommendations” page on the Vaccine Education Center’s website.A note about adult vaccines: AMA and SAVRRVaccination recommendations for adults have always been more complex to align than for children because adult vaccines have not been as much of a focus in the U.S. This situation is complicated by a fragmented healthcare system (e.g., many adults see specialists and not primary care providers), and the need for more complex medical care due to multiple or chronic health conditions. Both of which can affect individual risk for vaccine-preventable diseases, need for vaccination and access to vaccines. Given this, two additional groups have taken on roles that focus on adult vaccines in the current approach:American Medical Association (AMA) has developed a website, SpreadTheFacts.org, to help the public and healthcare providers stay abreast of the latest adult vaccine recommendations.Summit Adult Vaccine Recommendations Review (SAVRR) Council has formed to focus on challenges related to effective implementation of vaccine recommendations.Using recommendations: States, insurance companies, healthcare systems and providersEven when vaccines are available and recommendations exist, others play a role in whether people have an opportunity to get vaccinated. Many states are trying to fill some of the gaps created by federal changes. Several states are working to change their laws, so they are no longer reliant only on federal vaccine recommendations, and some have formed regional networks to share information and resources: Governor’s Public Health AllianceWest Coast Health AllianceNortheast Public Health CollaborativeTo date, most insurance companies have continued to cover vaccines, but the requirement to cover these costs stems from federal laws. The professional organization for insurance providers is called America’s Health Insurance Plans (AHIP), and they also historically participated in the vaccine recommendation process. Currently, states and other professional organizations continue working with them with a focus on maintaining insurance coverage for vaccines despite the federal changes.Healthcare systems and independent healthcare providers are also relying on the activities of the VIP, professional societies and states to continue ensuring that they are offering the latest, science-informed care to their patients and families.In sumWhile significant changes have taken place at the federal level, including loss of experience, expertise, and financial and programmatic resources, many of the thousands of other people who were involved in the process of delivering vaccines in the U.S. have come together in novel ways in an attempt to continue maintaining access to these important preventive tools. The situation is not ideal, but it is heroic. And as healthcare consumers, we owe a great debt to those working behind the scenes to continue the fight against the true enemy — the pathogens that can maim and kill us. We must all hope that these efforts are required for only a short time, and that sometime soon, we can again look to a federal government that puts resources and value into keeping Americans healthy by preventing infectious diseases that were once feared and overcome.Download a PDF version of this article.
