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Immunize.org summarizes ACIP’s September 18–19 meeting with recommendations on MMRV, hepatitis B screening, and 2025–26 COVID-19 vaccines
The 12 members of CDC’s Advisory Committee on Immunization Practices (ACIP) met on September 18–19 to discuss the measles, mumps, rubella, and varicella combination vaccine, MMRV (ProQuad, Merck), the HepB birth dose, and the use of COVID-19 vaccines for the 2025–26 season.
Committee Background
Seven of the current ACIP members were appointed by the HHS Secretary in June, following the earlier dismissal of all 17 members of the ACIP. He appointed an additional five members on September 15.
In several ways, this committee and this meeting were different from typical ACIP meetings. Most of the current members do not have extensive expertise in vaccinology, vaccine policy development, or vaccine program implementation. Prior to this meeting, representatives of the liaison organizations and CDC subject matter experts were dismissed from ACIP work groups. The standardized Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process typically presented for evaluating the quality of evidence considered by work groups was not used, nor was ACIP’s standard Evidence to Recommendations deliberation framework, normally used by work groups and presented to support proposed recommendations.
As a consequence of these changes, professional societies including the American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists (ACOG), and American Academy of Family Physicians (AAFP) recently began issuing immunization recommendations separate from ACIP. Several states have organized individual or collective actions related to issuing their own vaccine recommendations and standing orders.
The federal Vaccines for Children (VFC) program and a variety of aspects of state vaccine policy, insurance coverage, and scope of practice for some licensed professionals are all tied to the decisions of ACIP. This report highlights the issues presented and the decisions made by the committee.
Vote Summary
During the meeting, ACIP voted:
- To not recommend use of MMRV vaccine (ProQuad, Merck) for children younger than age 4 years. The committee passed a VFC program resolution to align it with this recommendation.
- To recommend hepatitis B testing for all pregnant women (a current recommendation of the U.S. Preventive Services Task Force [USPSTF]).
- To recommend individual-based decision-making (also known as shared clinical decision-making [SCDM]) for COVID-19 vaccination of all people age 6 months and older following discussion with a healthcare professional. ACIP also voted to recommend that additional topics be added to the COVID-19 VIS and covered in informed consent discussions.
Details and the exact wording of votes are provided below.
Presentation slides and detailed CDC background briefing materials on these issues are available online and may be downloaded. Video recordings of the ACIP’s September 18 session and September 19 session are archived on YouTube.
MMRV (ProQuad, Merck) (vote)
Background
Individual vaccines for measles, mumps, and rubella were licensed in the United States in the 1960s, and the first combined MMR (MMR-II, Merck) vaccine was licensed in 1971. The vaccine against varicella (chickenpox) (Varivax, Merck) received FDA licensure in 1995. MMRV (ProQuad, Merck), the combination vaccine against all four diseases, was licensed in 2005. When ACIP initially recommended MMRV, consistent with ACIP’s general recommendations on the use of combination vaccines, use of MMRV was preferred over separate injections at the same visit (abbreviated MMR+V) for both the first and second dose to reduce the number of injections needed.
As MMRV became widely used, a small increased risk for febrile seizures was identified during the first two weeks after vaccination when MMRV was used (instead of MMR+V) for the first dose of these antigens given to children age 12 through 23 months. The risk was roughly 1 additional febrile seizure per 2,000 doses of MMRV, when compared to using MMR+V. There was no increased risk of febrile seizure after administering MMRV as a second dose, regardless of the age at administration. Febrile seizures may be triggered in young children by any cause of fever, are typically of short duration, and only a small minority of children who experience a febrile seizure go on to have long term problems. By age 5 years, 2–4% of children have had at least one simple febrile seizure, often due to early childhood infections and diseases.
Since 2010, to minimize the small risk of febrile seizure, CDC has recommended that a child receive separate injections of MMR+V for the first doses of these antigens, unless the parent or caregiver prefers the single MMRV injection. The National Immunization Survey (NIS) and state immunization information systems (IIS) indicate only about 15% of children younger than age 3 years receive their first dose as MMRV, while MMRV is used for about 75% of second dose vaccinations among children age 4 through 6 years.
The committee identified no new risks or issues with the current schedule (i.e., MMR+V preferred for dose 1, and either MMR+V or MMRV for dose 2). Discussions on September 18 centered around the well-defined small increased risk of febrile seizure with the first dose of MMRV compared to the benefits of allowing families the option to choose fewer injections. There was no discussion about the evidence that second doses of MMRV given at age 15 months or older have not been associated with an increased risk of febrile seizure compared to MMR+V.
ACIP voted (8 yes, 3 no, 1 abstain) to recommend that the pediatric vaccine schedule should be updated to reflect the following change:
- For measles, mumps, rubella and varicella vaccines given before age 4 years, the combined MMRV vaccine is not recommended.
- Children in this age group should receive separate measles, mumps, and rubella vaccine and varicella vaccine (MMR+V).
ACIP conducted two votes on adoption of this language into a VFC program resolution, which provides specific details on vaccines provided through VFC. At the end of September 18, the committee voted not to update the VFC program and continue to allow use of MMRV for VFC-eligible children younger than age 4 years. The morning of September 19, the chair acknowledged that the committee did not understand what they were voting for. They then conducted a second vote on this topic to reverse the previous vote. ACIP voted a second time (9 yes, 3 abstain) to update the VFC resolution to remove MMRV as an option for vaccination of VFC-eligible children younger than age 4 years, aligning the VFC program with the committee’s recommendation.
HepB Birth Dose (vote)
Background
An estimated 2.4 million people in the United States are chronically infected with hepatitis B virus (HBV), half of whom are unaware of their infection. HBV is transmitted through contact with infected blood or body fluids or through contact with environmental surfaces contaminated by even microscopic amounts of infected blood or body fluids. The virus can remain viable on surfaces for up to 7 days after leaving the body.
Babies born to HBV-infected mothers have up to an 85% chance of acquiring HBV infection without intervention (ideally, HepB vaccination and administration of hepatitis B immune globulin [HBIG] within the first 12 hours of life). If infected, 90% will develop chronic HBV infection, and 25% will die prematurely due to cirrhosis or liver cancer. Administration of HBIG and a birth dose (within 24 hours) of HepB reduces the risk of mother-to-child transmission by approximately 94%. A dose of HepB alone within 24 hours of birth reduces the risk of infection by about 75%.
In 1991, CDC adopted a policy of routine infant vaccination, with a preference for vaccination at birth. By 2005, a routine birth dose (defined as vaccination before discharge from the birthing facility) was recommended. In 2018, CDC published the revised ACIP recommendation for the routine birth dose to be administered within 24 hours of life to optimize protection of newborns with unrecognized perinatal exposure to HBV. In 2021, CDC estimated that almost 18,000 infants were born to HBV-infected mothers in the United States. (Not stated in the meeting, but to demonstrate the success of this strategy: in 2020, just ten cases of perinatal HBV infection were reported to CDC.)
During the meeting, CDC experts presented the history and safety of hepatitis B birth dose vaccination. Anaphylaxis was described as the primary demonstrated risk of birth dose HepB, stated as occurring with a frequency of about 1.1 cases per 1 million birth doses administered. Anaphylaxis is extremely rare and can occur with any vaccination at any age.
The committee proposed a vote to recommend that the first dose of HepB for infants born to test-negative mothers not be given earlier than one month of age. The committee did not describe any specific problem with the current schedule as a rationale for proposing this change.
CDC reviewed several ways that relying solely upon prenatal testing of mothers to identify infants at risk of HBV could fail to protect infants from HBV infection. First, an estimated 12%–16% of U.S. pregnant women are not screened for HBV infection, despite longstanding recommendations to do so. They also noted errors related to use of incorrect screening tests, errors in interpreting or transcribing test results, lapses in providing HBIG and HepB to at-risk infants, and the risk of maternal infection after early prenatal screening. In addition, U.S. studies conducted before the routine birth dose recommendation repeatedly demonstrated that a small proportion of unvaccinated infants born to test-negative mothers acquired HBV infection from household, childcare, or unknown contacts.
ACIP voted unanimously (12 yes, 0 no) to recommend that all pregnant women should be tested for hepatitis B infection. (This is a current recommendation of the U.S. Preventive Services Task Force. ACIP members stated the vote was intended to encourage higher screening rates.)
On the morning of September 19, ACIP voted unanimously not to hold the vote proposed the previous day to change the current universal HepB birth dose recommendations . The chair indicated that the topic was tabled indefinitely.
COVID-19 Vaccine (vote)
CDC experts described the extensive monitoring of COVID-19 vaccine safety and effectiveness through several surveillance systems, particularly through laboratory-confirmed hospitalizations reported in COVID-NET, which includes approximately 10% of the U.S. population. The cumulative rates of COVID-19-associated hospitalizations from October 2024–September 2025 were highest among children younger than age 6 months (223/100,000) who are too young to be vaccinated and adults age 75 years and older (653/100,000).
Overall COVID-19 vaccination rates remain low. During the 2024–25 COVID-19 season, approximately 45% of adults age 65 years and older were vaccinated, but the vaccination rate fell to just 25% of people age 50 through 64 years and 14% of those age 18 through 49 years. Approximately 13% of children age 6 months through 17 years were up to date with COVID-19 vaccination at the end of April 2025. Up-to-date COVID-19 vaccination provided additional protection against emergency department and urgent care visits in both children and adults.
From August 2024–April 2025, 67% of COVID-19-vaccinated adults age 18 years and older received their vaccine in a pharmacy, with the remaining one-third being vaccinated at a doctor’s office, clinic, or other location.
CDC staff also described in detail their methods for identifying and evaluating vaccine safety signals from a variety of vaccine surveillance databases.
COVID-19 Work group Chair Retsef Levi presented a list of six “risks or uncertainties related to COVID-19 vaccine” that the current work group believed should be communicated to patients and medical providers in the COVID-19 Vaccine Information Statement (VIS) and during informed consent discussions with healthcare professionals. There was no evaluation of the quality or strength of evidence for these proposed risks and uncertainties.
The work group’s minority opinion was presented by Dr. Henry Bernstein, a pediatrician and former ACIP member. That presentation highlighted the concerns of three work group members about the barriers to vaccine access that would be created by the proposed shared clinical decision making (SCDM) recommendation and the proposed recommendation that a prescription be required. He also reviewed the impact of COVID-19 on young children and the evidence for COVID-19 vaccine safety when given during pregnancy.
Following robust discussion, ACIP narrowly did not approve the proposed recommendation that state and local jurisdictions should require patients to have a prescription to receive a COVID-19 vaccination (6 Yes, 6 No; in a tie vote, the ACIP Chair’s vote [no] determines the final result). ACIP approved the following three recommendations as reprinted below. The votes are listed in the sequence they were made:
Vote (12 yes, 0 no)
The pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines should be updated as follows:
- Adults 65 and older: Vaccination based on individual-based decision-making*
- Individuals 6 months to 64 years: Vaccination based on individual-based decision making - with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individual who are not at an increased risk, according to the CDC list of COVID-19 risk factors.
*also known as shared clinical decision making
Vote (11 yes, 1 no)
It is the sense of the committee that the CDC engages in an effort to promote more consistent and comprehensive informed consent processes, and as part of that considers adding language accessible to patients and medical providers to describe at least the six risks and uncertainties included in the WG chair presentation.
Vote (12 yes, 0 no)
It is the sense of the committee that in conversations with patients before COVID-19 vaccination, authorized healthcare providers discuss the risks and benefits of the vaccination for the individual patient. The discussion should consider known risk factors for severe outcomes from COVID-19, such as age, prior infections, immunosuppression, and certain comorbidities identified by the CDC, and include a discussion of the potential benefits and risks of vaccination and related uncertainties, especially those outlined in the vaccine information statement, as part of informed consent.
The September 19 votes do not exclude anyone who is age-eligible for COVID-19 vaccination from receiving COVID-19 vaccine following a discussion with a healthcare professional. Healthcare professionals who can engage in shared clinical decision-making with individuals include nurses, doctors, and pharmacists.
New Work Groups (announcements)
ACIP Chair Martin Kulldorff announced the formation of two new ACIP work groups:
- Vaccines in Pregnancy
- Childhood and Adolescent Vaccine Schedule (to review the schedule in its entirety, rather than individual vaccines)
Next meeting
The next ACIP meeting is expected to be held on October 22–23, 2025. Information about past and future ACIP meetings may be found on the ACIP website.
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