ACIP Meeting: Combined MMRV Vaccine, Hepatitis B Vaccine Restricted for Some Age Groups

On day 1 of a meeting of the Advisory Committee on Immunization Practices (ACIP) in Atlanta, Georgia, the committee voted 8 to 3, with 1 member abstaining, to recommend that the combined measles, mumps, rubella, and varicella (MMRV) vaccine should not be administered before 4 years of age, and that they should instead receive the separate measles, mumps, and rubella vaccine and varicella vaccine (MMR+V).¹

Additionally, they voted 12-0 to affirm the recommendation that all pregnant women be tested for hepatitis B (HBV) infection. However, a vote that the pediatric hepatitis B vaccine schedule should be altered for newborns was tabled, 12 to 1, after disagreement on the voting language. The recommendation would have reflected the following changes: if a mother tests negative for HBV, the first dose of the HBV vaccine should not be given to the infant until they are at least 1 month old, but infants can still receive a dose of the vaccine prior to 1 month according to shared clinical decision-making.¹

Robert W. Malone, a vaccinologist and ACIP member, offered the motion to table the HBV vaccine vote. It will be postponed and voted on at a later date after alterations to the voting question.¹

With these new recommendations awaiting sign-off from the CDC director and Health and Human Services secretary, pharmacists must consider upcoming impacts to their practices and offered services. They stand to play a critical role in the coming weeks and months in explaining the new recommendations to patients and educating them on how to best protect themselves and their loved ones.

Prior to the votes, the committee listened to presentations regarding the MMRV and HBV vaccines.¹

Measles, Mumps, Rubella, and Varicella Vaccine

John Su, acting director of the Immunization Safety Office at CDC, focused his presentation on the possible risk of febrile seizures following receipt of a combination MMRV vaccine. The MMRV vaccine was first licensed in 2005, being preferred over separate administration of MMR and varicella vaccines due to ease of administration and comparable immunogenicity. Febrile seizures can occur between ages 6 months and 5 years; they are typically of short duration and resolve without underlying symptoms. Su presented data regarding the incidence of febrile seizures following receipt of an MMRV vaccine.²

One study cited by Su shows that, following the first dose of MMRV vaccination among infants aged 12 through 23 months, the risk of febrile seizures was elevated 7 to 10 days following vaccination; however, the risk of seizures occurring in other postvaccination periods was similar between dose 1 of MMRV and MMR+V, according to this investigator group. Su also noted research indicating that children aged 4 through 6 years who receive the second dose of MMRV do not have an increased risk of febrile seizures compared with those receiving dose 2 of MMR+V.^2-4

Some committee members expressed concerns regarding removing the combination vaccine option for children aged below 4 years. Cody Meissner, MD, professor of pediatrics at the Geisel School of Medicine at Dartmouth, expressed hesitation about the removal of the option, saying it would make decisions more complicated for families.¹

"What we're saying is we don't trust parents to make a decision," Meissner explained. "I prefer that families have an option to make a selection. If a parent wants to get a single dose, why are we taking away that option?"¹

During a section that allowed statements from representatives of medical societies, Jason Goldman, MD, FACP, president of the American College of Physicians, decried the recommendation, saying it would cause “more confusion” for the general public, and spoke out against the decision to no longer include the expertise of volunteer liaisons from health care organizations in ACIP working groups, arguing that individuals who are experts in the subject matter were being excluded from providing valuable real-world context.^1,5

"You are taking away the choice of parents to have an informed consent and discussion with their physician on what they want to do for the health and benefit of their children," Goldman exclaimed. “This was not a thoroughly vetted discussion.”¹

Hepatitis B Vaccine

Su also presented data regarding the safety of the HBV vaccine. HBV, specifically infections spread through pregnancy, is a major public health concern. According to the CDC, an estimated 18,000 infants were born to HBV-positive individuals in the United States in 2021. Perinatal infection can be caused when a pregnant patient with HBV infection gives birth and does not receive postexposure immunoprophylaxis, which consists of a hepatitis B birth dose and hepatitis B immunoglobulin within 12 hours.^6,7

The ACIP currently recommends, since 2018, that all pregnant women be tested for hepatitis B surface antigen (HBsAg) and that all infants receive the hepatitis B vaccine (HepB) at birth, regardless of the infection status of the birthing parent. On the CDC’s website, they highlight the positive benefits of administering the first dose of HepB soon after birth to act as a safety net if HBsAg status is either unknown or incorrectly documented. Furthermore, the CDC says that initiating the HepB vaccine series at birth increases the likelihood of the child completing the vaccine series on schedule.^7,8

Su’s presentation specifically focused on the safety of administering the HepB vaccine within the first 30 days of life. A CDC-led systematic review found that HepB administered at birth did not lead to increased risk of allergic reaction, all-cause mortality, expected or unexpected deaths, deaths due to sudden infant death syndrome, or seizures. Furthermore, compared with those who did not receive HepB at birth, there was a reduction in risk for HepB recipients in having an invasive diagnostic procedure performed and bronchopulmonary dysplasia.⁶

Flor Muñoz, MD, MSc, member of the Vaccines and Related Biological Products Advisory Committee of the FDA and member of the National Foundation for Infectious Diseases board of directors, questioned the panel regarding the need to alter the pediatric immunization schedule for HepB.¹

“Is there a reason the committee can provide for making the change?” Muñoz asked. “The data speaks for itself in that we have seen a significant change in the incidence of cases of hepatitis B, and because of that, we don’t see the long-term effects of hepatitis B disease.”¹

In response, Malone noted that Americans have expressed increasing concerns regarding the administration of a perinatal vaccination as soon as children are born, aligning with a growing wave of distrust in the medical establishment and health care professionals. Malone said taking up the vote was acknowledging and discussing their concerns.¹

REFERENCES

1. Meeting of the Advisory Committee on Immunization Practices (ACIP) – September 18, 2025 – Day 1 of 2. Streamed on YouTube on September 18, 2025. Accessed on September 18, 2025. Accessible: https://www.youtube.com/live/-6uBNXsYRHQ

2. Su J. Febrile Seizures following Measles, Mumps, Rubella, and Varicella (MMRV) vaccine. Presented on September 18, 2025 in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/03-su-mmrv-508.pdf

3. Klein NP, Fireman B, Yih WK, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics. 2010;126(1):e1-8. doi: 10.1542/peds.2010-0665

4. Marin M, Broder K, Temte J, et al. Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Recommendations and Reports: MMWR. 2010;59(RR03):1-12. Accessible: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5903a1.htm

5. O’Reilly KB. Latest ACIP move is dangerous to the nation’s health. American Medical Association. Published August 1, 2025. Accessed September 18, 2025. https://www.ama-assn.org/public-health/prevention-wellness/latest-acip-move-dangerous-nation-s-health

6. Su J. Review of the Safety of Hepatitis B Birth Dose Vaccination. Presented on September 18, 2025 in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/02-su-hep-b-508.pdf

7. CDC—Hepatitis B. Clinical Overview of Perinatal Hepatitis B. Last Updated September 18, 2025. Accessed September 18, 2025. https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/?CDC_AAref_Val=https://www.cdc.gov/hepatitis/hbv/perinatalxmtn.htm

8. Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Re.p 2018;67(No. RR-1):1–31. : doi:10.15585/mmwr.rr6701a1