What Clinicians Need to Know About ACIP’s September 2025 Meeting
Key Highlights
- COVID-19 Vaccines: The Advisory Committee on Immunization Practices (ACIP) unanimously voted to shift COVID-19 vaccination for all ages to shared clinical decision-making. Vaccination remains available for anyone who wants it after consulting a provider, but routine, universal recommendations were removed—even for adults 65 and older. A tied vote rejected requiring a prescription. ACIP also asked CDC to strengthen informed consent language by including risks and uncertainties in vaccine information statements.1-3
- Hepatitis B Birth Dose: A proposal to delay the universal birth dose of hepatitis B vaccine was tabled indefinitely due to lack of consensus and insufficient new evidence. The birth dose remains recommended within 24 hours of birth.4 ACIP did vote unanimously to recommend hepatitis B screening for all pregnant individuals.4
- MMRV Vaccine: ACIP voted to recommend against use of the measles, mumps, rubella, and varicella (MMRV) combination vaccine for the first dose in children under 4 years, citing higher febrile seizure risk compared to separate MMR and varicella shots.5-6 A follow-up vote aligned the Vaccines for Children program with this policy to ensure consistent guidance across socioeconomic groups.5
The Advisory Committee on Immunization Practices (ACIP) met on September 18–19, 2025, to review US vaccination recommendations. Over 2 days of presentations and debate, ACIP issued new guidance on COVID-19 vaccination, deferred a decision on the timing of the hepatitis B birth dose, and clarified policy on the measles, mumps, rubella, and varicella (MMRV) combination vaccine. The meeting’s outcomes have important implications for clinicians and patients, as ACIP recommendations guide the CDC’s immunization schedule and influence vaccine access, insurance coverage, and public health practice.
COVID-19 Vaccine Recommendations
On September 19, ACIP voted to move all COVID-19 vaccination into the realm of shared clinical decision-making, meaning individuals who want the vaccine may receive it after consulting a healthcare provider.1 This applies to children 6 months and older, adolescents, and adults, including those 65 and older.
For high-risk groups—adults 65 and older, people with chronic medical conditions, and the immunocompromised—the committee emphasized that the risk-benefit profile still strongly favors vaccination. For healthy children and young adults, evidence shows lower rates of severe outcomes from COVID-19, leading ACIP to recommend that vaccination decisions be made through individualized discussions between patients and providers.2
A 6–6 tie on a proposal to require a prescription for COVID-19 vaccination was broken by the chair voting against the requirement, leaving access open to anyone who consults a willing provider.2,7
Informed Consent and Safety
In a separate vote, ACIP recommended that CDC update vaccine information statements to include at least six categories of risks and uncertainties.2 These include:
- Short-lived protection from seasonal boosters.
- Rare but serious risks such as myocarditis and pericarditis.
- Reports of post-vaccine syndromes with lingering symptoms.
- The persistence of vaccine mRNA and lipid nanoparticles in the body.
- Limited safety data for use during pregnancy.2
While many of these areas remain under study, the committee emphasized transparency in patient communication.1
In practice, this means COVID-19 vaccines are still available and covered for all ages, though recommendations now emphasize shared decision-making and focused counseling for patients at higher risk.7
Hepatitis B Birth Dose
On September 18, ACIP debated whether to alter the long-standing policy of giving hepatitis B vaccine within 24 hours of birth to all newborns.4
The draft proposal would have allowed infants born to hepatitis B surface antigen (HBsAg)–negative mothers to delay their first dose until up to 1 month of age.4
CDC staff reviewed decades of data showing that the birth dose serves as a critical safety net.4 Key points included:
- Perinatal hepatitis B can have devastating outcomes, and the birth dose plus hepatitis B immune globulin (HBIG) dramatically reduces transmission from infected mothers.
- Missed or delayed maternal screening can leave some infants vulnerable.
- Studies show hepatitis B vaccine is safe in newborns, with no evidence of serious harms.8
Several ACIP members noted that no new evidence justified a change.4
The committee ultimately voted 11–1 to postpone the vote indefinitely, leaving the birth dose recommendation unchanged.7
Screening in Pregnancy
ACIP unanimously voted to recommend that all pregnant individuals be screened for hepatitis B.4
MMRV Vaccine
ACIP also revisited guidance on the measles, mumps, rubella, and varicella (MMRV) combination vaccine.5
CDC analyses presented at the meeting confirm that children 12-23 months old who receive MMRV are about twice as likely to experience febrile seizures 7-10 days after vaccination compared with children who receive separate MMR and varicella vaccines.5-6
The absolute risk is small—about five extra seizures per 10,000 doses—but seizures often require emergency evaluation.6 No efficacy advantage has been shown for MMRV.
The committee voted to recommend against use of MMRV for the first dose in children under 4 years.5 For the second dose, MMRV remains an option.
A follow-up vote aligned the Vaccines for Children (VFC) program with this policy, ensuring consistent guidance regardless of insurance coverage.5
Clinical Implications
COVID-19
Clinicians should anticipate more nuanced discussions with patients about COVID-19 vaccination. For adults 65 and older, individuals with chronic medical conditions, and immunocompromised patients, the risk of severe outcomes remains high, and vaccination should continue to be strongly recommended.2,3,7 For younger, healthier patients, ACIP recommended that decisions be made through shared clinical decision-making; providers should discuss benefits, risks, and uncertainties, and let patients decide if vaccination aligns with their health goals.1-3 Because ACIP rejected a prescription requirement, access remains open for all who request the vaccine after counseling.7
Hepatitis B
The hepatitis B birth dose policy remains unchanged, and hospitals should continue administering it within 24 hours of delivery.4,8 ACIP’s unanimous vote in favor of universal screening in pregnancy underscores the need for obstetric and prenatal providers to ensure screening is performed and documented at every pregnancy.4 Pediatricians and family physicians can help close the loop by confirming maternal HBsAg status at the first newborn visit and ensuring infants of positive mothers received both vaccine and HBIG.4
MMRV
For pediatric providers, ACIP’s vote means moving away from MMRV as a first-dose option for children under 4 years. The committee reviewed data showing a higher risk of febrile seizures with MMRV compared to separate MMR and varicella shots.5,6 Although the absolute risk was small, the committee voted to recommend against MMRV for the first dose.5 For the second dose, given at 4–6 years, MMRV remains an option since the increased risk has not been observed.5,6
Understanding ACIP’s Role
ACIP recommendations become CDC policy once approved by the Director and published in Morbidity and Mortality Weekly Report (MMWR). This determines vaccine coverage and clinical schedules nationwide.7
References
- Centers for Disease Control and Prevention. ACIP meeting agenda, September 18–19, 2025. CDC. Accessed September 22, 2025. https://www.cdc.gov/acip/downloads/agendas/Final-posted-2025-09-17-508.pdf
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) – day 1 of 2. YouTube. Published September 18, 2025. Accessed September 22, 2025. https://www.youtube.com/live/-6uBNXsYRHQ
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) – day 2 of 2. YouTube. Published September 19, 2025. Accessed September 22, 2025. https://www.youtube.com/live/_9ChY9SpPlY
- Langer A, Su J. Hepatitis B birth dose: evidence and safety review. Talk presented at: CDC ACIP Meeting; September 18–19, 2025; Atlanta, GA. Accessed September 22, 2025. https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/02-langer-hep-b-508.pdf
- Srinivasan A, Su J. MMRV vaccine safety and febrile seizure risk. Talk presented at: CDC ACIP Meeting; September 18–19, 2025; Atlanta, GA. Accessed September 22, 2025. https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/03-su-mmrv-508.pdf
- Centers for Disease Control and Prevention. MMRV vaccine safety summary. CDC. Accessed September 22, 2025. https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/MMRV-vaccine-safety-summary-508.pdf
- Goodman B, Gumbrecht J. CDC advisers shift to shared clinical decision-making for COVID-19 vaccination. CNN. September 19, 2025. Accessed September 22, 2025. https://www.cnn.com/2025/09/19/health/cdc-acip-covid-19-vaccine-recommendation
- Centers for Disease Control and Prevention. Hepatitis B birth dose safety review. CDC. Accessed September 22, 2025. https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/hep-b-birth-dose-briefing-508.pdf
