ACIP Narrows Vaccine Recommendations for COVID-19 and MMRV, but Preserves Existing Recommendation for Hepatitis B

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At its meeting on September 18 and 19, the Advisory Committee on Immunization Practices (ACIP) voted to narrow its vaccine recommendations for COVID-19 and the pediatric combination vaccine for measles, mumps, rubella, and varicella (MMRV), as summarized in a . Specifically:

• ACIP continues to recommend COVID-19 vaccine for adults and children above the age of 6 months, but now recommends “shared clinical decision making” for all populations.
• In lieu of MMRV, ACIP now recommends that children under four receive separate vaccinations for MMR and varicella. The MMRV combination vaccine remains recommended for children over four.

Although ACIP discussed pediatric hepatitis B vaccinations, the Committee did not vote on any changes, preserving (at least for now) the existing recommendation of vaccinating newborns.

See below for additional discussion of ACIP’s deliberations, as well as an overview of how ACIP’s recommendations establish minimum coverage requirements, among other ripple effects.

Days before ACIP’s September session, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. five additional voting members. Several of the newly appointed members have publicly expressed skepticism of certain federal vaccine recommendations, continuing a trend in ACIP appointments following the dismissal of all 17 ACIP members in June.

ACIP recommendations affect coverage requirements, among other effects. Once ACIP’s recommendations are approved by the Centers for Disease Control & Prevention (CDC), those vaccinations must be covered, without cost sharing, by all major health care payors (including Medicaid, Medicare, Marketplace plans, and employer-sponsored plans). ACIP recommendations establish a floor, but not a ceiling. Payors generally remain free to cover additional vaccines and vaccine indications.

ACIP also votes on the product list for the , which supplies vaccines free of charge to participating providers for vaccinating children and youth who are covered by Medicaid, uninsured, underinsured, or American Indian/Alaska Native.

For purposes of both coverage requirements and the VFC list, applicable ACIP recommendations include not only standard recommendations for “routine use” (i.e., ACIP recommends the vaccine for everyone in the relevant population), but also recommendations for shared clinical decision making, which, , means the decision should be “individually based and informed by a decision process between the health care provider and the patient or parent/guardian.” CDC notes that the recommended counseling can be provided by providers such as pharmacists, registered nurses, and physician assistants.

ACIP’s recommendations have knock-on effects in other areas as well. Many states have incorporated ACIP recommendations into their laws on pharmacist vaccination authority, as well as vaccination requirements for daycares, schools, and health care workers. ACIP recommendations also factor into certain liability protections for vaccinators and vaccine manufacturers.

COVID-19: ACIP recommends vaccination, subject to shared clinical decision making, for all adults and children older than 6 months. As of May, CDC had already adopted a “shared clinical decision making” recommendation for COVID-19 vaccine as to non-immunocompromised children, but maintained a standard recommendation for routine use as to adults and immunocompromised children.

ACIP concluded that, for children and adults under 65, the COVID-19 vaccine’s risk/benefit profile is most “favorable” for individuals at increased risk for severe complications from COVID-19, consistent with the Food and Drug Administration’s (FDA’s) decision to limit licensure of the 2025–26 COVID-19 vaccine to adults 65 and above and other high-risk individuals. Unlike FDA, however, ACIP declined to limit its recommendation to only those high-risk groups, opting instead to recommend shared clinical decision making. The Committee also voted down (through a tiebreaking vote by the Chair) a recommendation to require a prescription for COVID-19 vaccines, which may have significantly curtailed access to pharmacy-based vaccinations. The majority of adult COVID-19 vaccines are administered in the pharmacy setting, making this a key site for enhancing vaccine access and uptake.

Practically, ACIP’s shared clinical decision making recommendation means major payers and VFC must continue to cover the COVID-19 vaccine without patient cost sharing. As for pharmacy-based access, this recommendation likely preserves existing pharmacist vaccination authority for COVID-19, although the precise impacts may vary depending on each state’s specific laws around scope of practice—including a limited number of states that limit pharmacists to specific vaccine indications listed on the FDA-approved label.

MMRV: For children under age 4, ACIP recommends separate vaccinations for MMR and varicella. Since 2021, CDC has separate vaccinations for this population, while noting that “MMRV may be used if parents or caregivers express a preference.” ACIP is now recommending that CDC strike that exception, including with respect to the VFC Program’s product list. (ACIP continues to recommend MMRV for subsequent doses in this vaccine series for children ages 4 and up.)

Reporting suggests that elected the MMRV combination vaccine for young children. It remains to be seen whether Medicaid programs and commercial plans will eliminate no-cost MMRV coverage in this scenario, as will be permissible assuming CDC finalizes this recommendation. The health plan association AHIP has to continued coverage of all vaccines in accordance with CDC’s pre-September recommendations through the end of 2026. In the near term, practices that solely stock MMRV will need to shift inventories, update order sets, and communicate with families.

Hepatitis B: No change at this time. ACIP may revisit in the future. Currently, CDC that pregnant people be screened for hepatitis B, and that newborns receive the hepatitis B vaccine. At the September session, ACIP unanimously reaffirmed universal prenatal testing. The Committee also considered a proposal to delay infant vaccination until at least one month after birth for babies born to mothers who test negative for hepatitis B, while allowing earlier vaccination under shared clinical decision making. The Committee did not bring that proposal to a vote, but suggested they may reconsider this proposal at future meetings. Members requested a full evidence-to-recommend (ETR)/Grading of Recommendations Assessment, Development and Evaluation (GRADE) package, including neonatal and prematurity-specific safety data, implementation and equity considerations, and clearer U.S. epidemiology, before considering any schedule change.

Next steps and state responses. As noted, ACIP’s recommendations take legal force only after they are finalized and/or modified by the CDC Director. Following the August 27 dismissal of former CDC Director Susan Monarez—allegedly because of a disagreement with Secretary Kennedy over updated vaccine recommendations—that responsibility falls to the acting CDC Director, Deputy HHS Secretary Jim O’Neill. O’Neill is expected to align closely with the Secretary’s vaccine views, given his close ties to the Secretary and the circumstances surrounding Monarez’s departure.

Meanwhile, in light of ongoing federal developments, officials in several states have been taking action to preserve vaccine coverage, pharmacist vaccination authority, and school-entry vaccination requirements, whether through state-level action or through regional alliances of neighboring states.

ACIP is an expert advisory committee created by the Centers for Disease Control & Prevention (CDC) to issue recommendations on appropriate vaccine use.

For more on the termination of previous ACIP members, Manatt on Health subscribers can see the June 16 of Insights This Week.

For more on the new federal framework for COVID-19 vaccines, Manatt on Health subscribers can see the June 2 of Insights This Week.

For additional details on the FDA COVID-19 vaccine approvals, Manatt on Health subscribers can see the September 8 of Insights This Week.

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