Capstone believes state-level rollbacks and confusion over federal regulations will reduce vaccine uptake 5%–15% in the near term (1-2 years), raising costs for payors. In the longer term (5-7 years), US Food and Drug Administration (FDA) scrutiny will compress vaccine pipelines and increase clinical trial costs for manufacturers and contract research organizations (CROs).
- Following a federal ruling blocking the Centers for Disease Control and Prevention’s (CDC) revised vaccine schedule, the White House pressured the Department of Health and Human Services (HHS) to pull back on anti-vaccine policies in response to increasingly negative commentary on shifting vaccine regulations.
- Despite the Trump administration’s recent course correction, noise around the federal childhood vaccine schedule and shifting statelevel vaccine requirements are likely to create near-term confusion for providers and patients, reducing vaccine uptake despite continued coverage and reimbursement.
- Payors will face near-term headwinds as reduced vaccine uptake leads to more high-acuity patients, increasing costs. Manufacturers and CROs will face long-term headwinds from vaccine pipeline compression as increased scrutiny of new products and imposition of additional testing metrics extend timelines and increase costs for clinical trials.
What Changed
Under the direction of Secretary Robert F. Kennedy Jr., HHS enacted changes to vaccine schedules, recommendations, and approval standards. Most recently, the CDC issued a revised childhood vaccine schedule, reducing the number of universally recommended vaccines from 18 to 11. In March, however, a federal judge granted a motion to block implementation of the revised schedule.
Vaccine Coverage and Reimbursement
Changes to the CDC’s vaccine schedule generally do not directly affect vaccine coverage and access. Insurers and providers are not obligated to follow schedule changes, particularly without corresponding recommendations from the Advisory Committee on Immunization Practices (ACIP), which votes on new schedules on a by-vaccine basis.
Even then, ACIP’s recommendations, like the CDC schedule, are non-binding with two programspecific exceptions—the Vaccines for Children (VFC) program and Affordable Care Act (ACA) marketplace plans. Historically, health plans have used the federal vaccine schedule as a benchmark for determining coverage, but they are not required to link coverage to federal recommendations. Capstone believes payors are unlikely to voluntarily limit coverage for vaccines.
If HHS successfully appeals the March ruling, Capstone expects it will take at least a year for ACIP to vote on each of the downgraded vaccines. That is because ACIP only meets about three times a year and has experienced numerous delays over the past year. In 2025, the committee was forced to delay its vote on Hepatitis B vaccines for newborns due to procedural and language concerns from members. ACIP’s first meeting of 2026, which was already delayed from February to March, was canceled after a federal judge stayed multiple ACIP appointments by Kennedy.
Regardless of ACIP’s recommendations or the status of the revised schedule, Capstone expects health plans to continue offering comprehensive vaccine coverage to reduce the incidence of hospitalizations and higher-cost treatments.
Vaccine Uptake
While potential revisions to federal requirements are unlikely to affect vaccine coverage and reimbursements, Capstone believes the recent noise will create confusion among patients and providers, reducing overall uptake in the short term. Parents and providers are likely to be uncertain about whether downgraded vaccines are still covered by their insurance, leading to increased vaccination deferrals. Some parents may also interpret the administration’s attempt to downgrade certain vaccines as a signal that they are unsafe, further reducing uptake and fueling vaccine skepticism. Ongoing legal battles over the implementation of the revised schedule are likely to heighten the confusion.
The problem is further compounded by pending state legislation that would roll back vaccine requirements. For example, states such as Idaho and Louisiana have passed or proposed medical freedom laws that restrict states from requiring vaccines in businesses or schools, which we expect will be a major driver of reduced vaccine uptake.
Exhibit 1: Recent State Legislation Restricting or Limiting Vaccine Uptake
| State | Bill | Overview | Status |
| ID | H 290 | Removed the state board of health’s authority to set daycare/school vaccine requirements; repealed the Childhood Immunization Policy Commission and prohibited businesses/schools from requiring vaccines. | Enacted |
| LA | HB 926 | Prohibits the use of vaccine status to determine admission to public buildings. | Proposed 2026 |
| WV | EO | Allows parents to request religious exemptions from school vaccine requirements. | Enacted |
| FL | SB 1756; HB 917 | Expands exemptions to include conscientious reasons for not vaccinating, in addition to religious and medical exemptions; requires doctors to accept patients regardless of vaccination status. | Proposed 2026 |
| ME | LD 727 | Would remove health department authority to determine school vaccine requirements, partly reversing a 2019 law that eliminated non-medical exemptions. | Proposed 2025 |
| NH | HB 357 | Would remove state health officials’ ability to add vaccines to the required school attendance list via rulemaking. | Proposed 2025 |
| IA | SF 360 | Would prohibit all ‘gene-based vaccines’ (mRNA/DNA technology). | Proposed 2025 |
| MS | HB 1571 | Expanded non-medical exemptions to include religious, philosophical, or conscientious reasons. | Proposed 2025 |
Source: Legiscan
We expect that state-level policies and confusion at the federal level will reduce overall vaccine uptake regardless of payor coverage. Current forecasts anticipate a 5% to 15% drop over the next 25 years.
Payors are likely to face increased costs as reduced uptake results in more high-acuity patients. Particularly with the resurgence of severe but preventable conditions like measles, payors should expect an uptick in the incidence of communicable diseases, which are significantly more costly to payors than reimbursing vaccines
Vaccine Development
Manufacturers are relatively insulated from near-term impacts of potential changes to federal vaccine schedules, given that payors will maintain coverage. However, Capstone expects manufacturers to face moderate headwinds from shifting FDA policies.
The FDA is expected to increase scrutiny of Biologics License Applications (BLAs) for new vaccines as part of an ongoing effort to reportedly restore public confidence in vaccines. Scrutiny is heavily focused on COVID-19 vaccines and recently defunded mRNA vaccine research. The FDA and ACIP have both advocated for more stringent testing requirements; ACIP inquiries have closely scrutinized clinical trial structures, data interpretation, and risk tolerance for adverse vaccine effects.
In 2025, the FDA announced it would require randomized, placebo-controlled trials to obtain approval for new vaccines and imposed additional restrictions on COVID vaccine recommendations for different age cohorts. In the wake of Director Vinay Prasad’s departure, Tracy Beth Høeg, the current director of the Center for Drug Evaluation and Research (CDER), has similar concerns about vaccinations and approvals, and we expect she will drive continued FDA scrutiny of vaccines under Kennedy’s direction.
Additional testing requirements are expected to increase the cost of conducting clinical trials for new vaccines due to extended timelines and additional recruitment barriers for more complex trials. Capstone expects that the high level of scrutiny on vaccine development and endpoints will negatively impact the development of mRNA vaccines and some other infectious disease vaccines. Pipeline compression and clinical trial costs will be particularly impactful for CROs, as the development of new vaccines becomes less attractive amid rising costs and increased federal scrutiny.
What’s Next
HHS may attempt to appeal court rulings related to the vaccine schedules and ACIP appointments. However, pressure from the White House may prevent the agency from acting as aggressively on vaccine policy as Kennedy has previously suggested. Capstone is continuing to monitor the legal status of recent changes to federal standards and is closely following staffing changes that may shape FDA policy and state vaccine legislation.
Read more from Capstone’s healthcare team:
Why Cloud Fax Has Endured as a Healthcare Data Exchange Constant
European Digitization Gaps Create Opportunities for Healthcare IT Investment
Fraud Enforcement as Policy Weapon and How it Impacts Healthcare Investors
