Recent Developments Affecting Vaccine Coverage

On Friday, September 19, 2025, the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) announced new limitations on access to COVID-19 vaccines. The new directive recommends that “vaccination for COVID-19 be determined by individual decision-making” and “applies to all individuals six months and older.” As the new recommendation explains, “individual decision-making” requires some form of consultation or “shared clinical decision-making” with a health care provider, which could include “physicians, nurses, [or] pharmacists.”

A Rapidly Changing Federal Policy Landscape

Recent ACIP recommendations are the latest vaccine policy shift since Robert Kennedy, Jr. assumed the role of Secretary of Health and Human Services (HHS). In June, Sec. Kennedy replaced the entire ACIP panel approximately two weeks prior to ACIP’s meeting later that month. The reconstituted ACIP changed flu shot guidance at that meeting (which was formally adopted in July) and signaled additional action on the MMRV vaccine.

In early August, Sec. Kennedy announced that HHS was cancelling funding for nearly two dozen mRNA vaccine efforts totaling nearly half a billion dollars. The efforts had been coordinated by the Biomedical Advanced Research and Development Authority (BARDA). BARDA had theretofore taken a central role in pandemic preparedness efforts in addition to advancing vaccine innovations to guard against COVID-19, influenza, and respiratory syncytial virus (RSV).

At the end of the month, the US Food and Drug Administration (FDA) announced updated approvals of the new formulations of the COVID-19 vaccines produced by Pfizer (Comirnaty) and Moderna (Spikevax), which limited the availability of those vaccines to adults aged 65 and up or younger adults and children with at least one comorbidity. On September 15, HHS announced five additional new members of ACIP, just days before its most recent public meeting. ACIP then altered the recommendations for MMRV/MMR+V vaccination schedules – as it signaled it would back in June – recommending against the combined MMRV for children under four years old, but nevertheless opting to keep the combined MMRV covered under the federal Vaccines for Children (VFC) program for children on Medicaid or who are Medicaid-eligible, as well as certain indigenous populations.

ACIP also signaled a future conversation about neo-natal Hepatitis B vaccinations.

Implications

ACIP’s recommendations yield tangible impacts on health care nationwide. Federal regulations (45 C.F.R. § 147.130(a)(1)(ii)) mandate that health coverage payers and insurers provide access to all vaccines recommended by ACIP with no additional out-of-pocket costs. Thus, whether ACIP includes or omits a vaccine from its recommendations directly impacts whether many patients can afford the vaccine. Likewise, by federal law (42 U.S.C. § 1396s(e)), ACIP determines which vaccines are covered under VFC, and some states have already advised VFC-enrolled providers they “will no longer be required to routinely stock COVID-19 vaccines.”

ACIP must take separate actions to finalize its vaccine recommendations and to formalize which vaccines are covered under VFC. Consequently, ACIP’s withdrawal of its recommendation for the combined MMRV (in favor of separate MMR and Varicella vaccinations) but to preserve the MMRV’s covered status under VFC raises questions regarding vaccine standards of care.

While some states have simply reinforced the federal government’s new vaccine policies, others have taken state-level guidance in new directions. Florida, for example, recently announced plans to end its school vaccine mandates. By contrast, as of this writing, at least 17 states, including Connecticut, have issued responsive state-level guidance of their own that flows counter to the trend at the federal level. Other states, like California, Oregon, Washington, and Hawaii, have formed new state-level regional health alliances to issue regionally unified guidance, also counter to federal trends.

Here in Connecticut, Connecticut Department of Public Health issued new interim guidance earlier this month, based on recommendations from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians and confirmed COVID-19 shots are still available via the Connecticut Vaccine Program. That same day, the Connecticut Insurance Department confirmed that “coverage for COVID-19 immunizations is currently mandatory…regardless of ACIP’s position.” (Internal parenthetical omitted.) The following day, the Department of Consumer Protection explicitly permitted pharmacists to “continue to order, prescribe, and administer all [FDA]-approved or authorized COVID-19 vaccines” even to individuals who “fall outside the eligibility criteria authorized by the FDA.”

The above-referenced state-level guidance raises questions with respect to state sovereignty and police powers under the tenth amendment. As of now, however, such guidance has not been challenged in federal court. More importantly, whether individual patients may get vaccinated against COVID-19 for the upcoming respiratory virus season is now a heavily nuanced, jurisdiction-specific analysis. Similarly, whether the vaccine at issue is covered by insurance or will result in additional out-of-pocket costs may likely differ with each state.

The Health Law Group at Shipman remains committed to providing timely information to providers regarding rapidly changing Health Policy and Healthcare Privacy law. Please contact us with any questions about this or any other Health Law concerns you may have.