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Immunize.org summarizes ACIP’s April 15–16 meeting with recommendations for pentavalent meningococcal vaccine, chikungunya vaccine, and expanded RSV vaccine recommendations for high-risk adults
The CDC’s Advisory Committee on Immunization Practices (ACIP) met on April 15–16. This meeting had been postponed from the regularly scheduled February meeting. During the 2-day meeting, ACIP voted to recommend:
ACIP received an update on the current measles outbreak in the United States and reviewed preliminary estimates of influenza and COVID-19 vaccine effectiveness during the current season. The committee received information updates on the planned use of self-administered LAIV vaccine in the 2025–26 season, an updated mRNA COVID-19 vaccine, and a new monoclonal antibody product for infant RSV prevention. The group also reviewed preliminary information on potential recommendation changes for mpox, HPV, and CMV vaccines and heard updates on the work of the pneumococcal and Lyme disease vaccine workgroups.
Presentation slides are available online. Highlights of the meeting, focusing on vaccines with new recommendations, appear below. Meningococcal vaccine (information and vote) Pentavalent meningococcal vaccine Most invasive meningococcal disease in the United States is caused by Neisseria meningitidis serogroups B, C, W, and Y. Separate vaccines have been licensed and recommended to protect against serogroups A, C, W, Y (MenACWY) and B (MenB) for years. The two brands of MenB (Bexsero, GSK; Trumenba, Pfizer) are not interchangeable. In 2023, FDA licensed Pfizer’s pentavalent MenABCWY (Penbraya) which includes the MenB product in Trumenba. ACIP recommended that Penbraya be used only when vaccination with both MenB (Trumenba) and MenACWY is desired at the same visit. On February 14, 2025, FDA licensed GSK’s MenABCWY, Penmenvy. This vaccine contains GSK’s MenACWY product (Menveo) and MenB product (Bexsero). CDC presentations to ACIP noted that use of Penmenvy produced an inferior immune response to one of the three reference strains of serogroup B meningococcus when compared to Bexsero administered on the recommended 6-month interval. ACIP members felt this difference did not warrant creating a different recommendation for Penmenvy and proceeded to align its use with existing recommendations for the Pfizer pentavalent vaccine, Penbraya. Following this recommendation means that a child could receive a quadrivalent MenACWY product at age 11–12 years, followed by a pentavalent MenABCWY at age 16 (if MenB is desired), followed by a single dose of the corresponding brand of MenB 6 months later (if MenB is desired). Providers who choose to offer a pentavalent option would need to stock at least three different meningococcal vaccine products. ACIP voted unanimously (15–0) to recommend that GSK’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the same visit.* *(1) healthy persons age 16–23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and (2) people age 10 years and older who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia) In a separate vote, ACIP voted unanimously (15–0) to include the pentavalent GSK vaccine in the Vaccines for Children program. MenACWY vaccine for young children The Menveo (GSK) brand of MenACWY vaccine is the only meningococcal vaccine currently licensed, recommended, and available in the United States for infants as young as age 2 months who are at increased risk of invasive meningococcal disease. MenQuadfi (Sanofi) MenACWY vaccine is currently approved beginning at age 2 years, but FDA approval for use as early as 2 months of age is anticipated in May 2025. Studies were presented demonstrating equivalent immunogenicity and safety of MenQuadfi compared to Menveo in this younger age group. The MenQuadfi group in the Sanofi clinical trial had a higher incidence of reported febrile seizures, although study evaluators determined that there were a variety of alternative causes in the affected infants and judged that the difference was not attributable to MenQuadfi. The meningococcal workgroup will continue to review this information for discussion at future meetings. Respiratory syncytial virus (RSV) (information and vote) Background A single dose of RSV vaccine is currently recommended for all adults age 75 years and older and adults age 60 through 74 years who are at increased risk of severe RSV disease. Data are currently insufficient to recommend revaccination. Vaccination of high-risk adults age 50 through 59 years Among older adults, hospitalization with serious RSV lower respiratory tract infection (LRTI) is strongly associated with the presence of high-risk comorbid conditions, such as congestive heart failure, chronic kidney disease, or chronic lung disease. An estimated 15,000–20,000 RSV-associated hospitalizations occur annually in U.S. adults age 50 through 59 years. About 31%–43% of adults in this age group have one or more chronic medical conditions associated with increased risk of severe RSV disease. There are three RSV vaccines available. Arexvy (GSK) is an adjuvanted protein subunit vaccine licensed for use in adults age 60 and older and high-risk adults age 50–59 years. Abrysvo (Pfizer) protein subunit vaccine is approved for routine use in adults age 60 years and older, during pregnancy at any age, and in high-risk adults age 18 through 59 years. Moderna’s mRNA RSV vaccine, mResvia, is approved for routine use in adults age 60 years and older and awaits an FDA decision on its use in high-risk adults age 18 through 59 years. Discussion: revaccination, coadministration Pfizer and Moderna presented information on their studies of revaccination of healthy adults with RSV vaccines. Similar to GSK’s revaccination data presented previously, revaccination after 1 or 2 years appears to restore antibody levels close to (but not higher than) the levels achieved by the initial dose. Because there is no simple connection (or correlate) between antibody levels and effectiveness against severe disease, it is not known how effective subsequent doses will be, compared with the initial dose, but the benefit may be similar. Other unmeasured elements of the immune response also play a role in vaccine effectiveness. For now, revaccination is not recommended, although it is expected to be recommended after more data become available. In other presentations, data was shown indicating that Arexvy and Shingrix (GSK), which both contain the ASO1 adjuvant, may be coadministered safely. ACIP considers it acceptable to coadminister RSV vaccines with any other vaccine. Due primarily to the possibility of more uncomfortable (though not unsafe) side effects, it is also acceptable to separate their administration. Patient preference and likelihood to return for future vaccination visits are among the factors to consider. ACIP voted (14 yes, 1 abstention) to recommend that adults age 50 through 59 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine. CDC will publish clinical considerations that describe the chronic medical conditions and other risk factors for severe RSV disease. For purposes of simplicity, ACIP members supported the CDC intent to use the same risk factors recommended to make RSV vaccination decisions for people age 60–74 years. Timing of RSV vaccination is unchanged. In most areas, vaccination is of greatest benefit when given from August to October. However, eligible adults may receive RSV vaccination year-round. Next Steps During the meeting, Moderna presented information on vaccine safety studies for use of mResvia in adults age 18 through 59 years. The vaccine produced a good immune response and was well-tolerated by recipients. The clinical trial identified no safety concerns, including no cases of thrombocytopenia, Guillain–Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM), acute myocarditis, or pericarditis. Use of RSV vaccines in high-risk adults younger than age 50 years will be discussed at the June 2025 meeting. Chikungunya vaccine (information and vote) Background Chikungunya virus is transmitted through the bite of an infected mosquito and is present in many tropical and subtropical regions. It can sometimes trigger explosive epidemics in affected areas. Chikungunya also can be acquired through exposure in a laboratory setting: Four cases have been reported in U.S. laboratory workers since chikungunya became a notifiable disease in 2015. Infected people can experience fever, joint pain, headache, muscle pain, joint swelling, and rash; joint pain may be debilitating and prolonged. Death is rare, occurring primarily in the extremes of age. Disease can be severe or fatal when a neonate is infected around the time of birth. There is no specific treatment. Recommendations for the use of the live attenuated chikungunya vaccine (CHIK-LA, Ixchiq, Valneva) in certain adult U.S. travelers vary. Routine use is recommended when an outbreak is ongoing at the destination. Vaccination may be considered when a traveler is planning a prolonged (longer than 6-month) stay in a region where chikungunya virus transmission has occurred in recent years, especially if health status or age increases risk of complications. Vaccination with CHIK-LA is also recommended for laboratory workers who routinely handle chikungunya virus specimens. Vimkunya (CHIK-VLP vaccine) A new, non-live, virus-like particle chikungunya vaccine, Vimkunya (CHIK-VLP, Bavarian Nordic), was licensed as a one-dose vaccine for people age 12 years and older in February 2025. The Vimkunya clinical trial estimated vaccine effectiveness based on an immune response assumed to predict clinical benefit. By 21 days post-vaccination, 97% of recipients showed a seroresponse, and 91% maintained that response at least 12 months after vaccination. Most reported adverse events (AEs) were mild and similar to rates seen in placebo groups. The amount of joint pain reported by vaccine and placebo recipients were similar (7% vs. 6%). Post-marketing safety surveillance will continue to detect any rare, serious AEs not detected in the clinical trial. Vaccination and pregnancy Vimkunya has not been studied during pregnancy, thus pregnancy is a precaution to its use. As a non-live vaccine, the theoretical risk to the fetus is expected to be minimal. Because of the risk of serious disease in infected neonates, CDC outlined the following guidance to prevent peripartum chikungunya infection:
ACIP reviewed in detail six reports to the Vaccine Adverse Events Reporting System (VAERS) of serious AEs following Ixchiq administration in older U.S. adults. All occurred within 3–5 days of vaccination in males age 67 through 86 years, most of whom had significant underlying health issues. All required hospitalization for neurologic or cardiac symptoms which mostly or completely resolved. None died. During this period, roughly 7,000 doses of Ixchiq were administered. CDC experts believe the association of CHIK-LA vaccine with these events is plausible. The committee accepted the workgroup’s proposal to add a precaution to the use of Ixchiq in people age 65 years and older while FDA and CDC investigations into the safety signal continue. ACIP conducted three separate votes on use of chikungunya vaccines for travelers and laboratory workers (all 14 yes, 1 abstention). Travelers:
Laboratory workers:
CDC provided an update on the current measles outbreak in the United States. Please refer to the IZ Express measles update article for the latest numbers. CDC deployed several staff to Texas to assist with the response to this ongoing outbreak. An ACIP member noted that extinguishing a similar large, 11-month-long measles outbreak in New York among an insular religious community with low vaccination rates was estimated to cost $30,000 to $50,000 per case, with 261 staff dedicated to the response at its peak. CDC noted that they were working to provide more funding support, but recent budget cuts limited available resources. 2024–25 season vaccine effectiveness Multiple systems in different regions are used each season to estimate influenza vaccine effectiveness (VE) at preventing outpatient clinic visits or hospitalizations. ACIP reviewed interim estimates of VE for the 2024–25 influenza vaccine as published in the February 27, 2025, MMWR. For children and adolescents, VE ranged from 32% to 60% in preventing outpatient visits and from 63% to 78% in preventing influenza-associated hospitalizations. Among adults, VE ranged from 36% to 54% in preventing outpatient visits and 41% to 55% against influenza-associated hospitalizations. 2025–26 season LAIV for home administration The committee also discussed the FDA-approved FluMist (LAIV3) for home administration to oneself or by a caregiver this fall. AstraZeneca representatives reviewed plans for this novel approach to seasonal influenza vaccination. Instructions have been carefully designed for use at home by people with no healthcare training, and an online pharmacy partner will be available to answer questions. Consumers will complete risk questionnaires online and order the vaccine from an online pharmacy for up to four eligible family members. Approved doses will be shipped in a single package ensuring cold chain integrity. Follow-up text messages will be sent to the recipient to confirm vaccine administration. Once the recipient confirms that the vaccine was administered, the online pharmacy will submit a report to the appropriate state immunization information system. Different instructions and NDC numbers on packages will differentiate LAIV for home use from LAIV shipped to healthcare settings. Next steps CDC reported that FDA recommends the composition of U.S.-licensed 2025–26 season trivalent influenza vaccine include a revised influenza A(H3N2) component. ACIP plans to vote on updates to the 2025–26 season influenza recommendations at the June 2025 meeting. COVID-19 vaccine (information) Epidemiology ACIP reviewed provisional data on COVID-19 epidemiology during the current season. So far this fall and winter, COVID-19-associated hospitalizations and deaths have been relatively low compared to prior seasons since 2021. Even so, preliminary estimates from October 1, 2024, through March 22, 2025, suggest there have been an estimated 1.9–3.2 million outpatient visits, 220,000–370,000 hospitalizations, and 26,000–43,000 deaths due to COVID-19. Many COVID-19-associated hospitalizations continue to occur each year outside the typical respiratory virus season. Children younger than age 18 years accounted for 4.3% of hospitalizations this season, primarily children younger than age 6 months. Among children eligible for vaccination, hospitalization rates were highest among children age 6 months through 4 years. Vaccination coverage remains very low in children and low in adults, with approximately 20% of adults age 18 years and older having received a 2024–2025 formulation vaccine. Despite low coverage, surveillance data from a variety of sources demonstrated that vaccination provided additional benefit in reducing emergency and urgent care visits, as well as hospitalizations among adults, especially those age 65 years and older. As is widely known, during 2020–22, an increased risk of myocarditis was reported following COVID-19 vaccination, primarily among teen and young adult males following primary series or first booster doses. CDC surveillance systems detected no increased risk in subsequent seasons, including the 2024–25 season to date. mRNA-1283 vaccine Moderna representatives provided an update on mRNA-1283, their next-generation COVID-19 vaccine. Its Phase 3 trials demonstrate similar or higher antibody responses compared to Spikevax (Moderna) with a lower dose of mRNA (10 mcg vs 50 mcg). Phase 3 studies found reported AEs for mRNA-1283 were similar to Spikevax; no myocarditis or pericarditis was reported. Moderna plans to have the new formulation available for use in fall 2025. Next steps ACIP plans to review vaccine availability and intends to vote to update its COVID-19 vaccine recommendations at the June meeting. Considerations include the possibility of changing to an age-based routine recommendation for ages 65 years and older, with recommendations based on identified risk factors at younger ages. Most work group members and consultants also favor retaining the option of vaccination for others who wish to be protected. Mpox vaccine (information) Epidemiology A global outbreak of Clade II mpox has been occurring since May 2022. Although the number of reported U.S. mpox cases has steadily fallen since fall 2024, there has not been a week without at least one mpox case reported to CDC. A smaller Clade I outbreak also developed in the Democratic Republic of the Congo and surrounding countries with occasional cases among travelers and their contacts in other countries. Although mpox is painful, it is generally not fatal; however, it can be devastating and deadly in people who are significantly immunocompromised. Vaccine recommendations In 2023, ACIP voted to recommend a 2-dose mpox vaccine (Jynneos, Bavarian Nordic) series for people age 18 years and older at risk of exposure during an outbreak or with behavioral risks for exposure to mpox in the absence of an outbreak. The risk groups recommended for vaccination are unchanged, though the wording of the recommendation was recently modified to comply with Presidential executive orders. Infectious disease modeling shows that even modest vaccination coverage among those at risk reduces the likelihood and magnitude of mpox outbreaks. Vaccine coverage in high-risk groups in the United States is low, at about 26% 2-dose coverage among people at risk, which could lead to larger outbreaks. FDA is considering licensure of Jynneos down to age 12 years. In preparation, the ACIP mpox workgroup is evaluating data to expand the current recommendation to include adolescents age 12 through 17 years at risk of exposure during an outbreak and is considering also expanding the current risk-based routine recommendation to include adolescents at risk in the absence of an outbreak. CDC presented new data from a Phase 2 clinical trial supporting the safety and immunogenicity of mpox vaccine in adolescents and reviewed the Evidence to Recommendations framework for extension of mpox vaccine recommendations into this younger age group. Next steps The options to expand recommendations to include adolescents at risk of mpox infection will be reviewed and considered at ACIP’s June meeting. Human papillomavirus (HPV) vaccine (information) HPV vaccine was first licensed in the United States in 2006. The HPV vaccine workgroup updated the committee on its evaluation of the wording of the age for routine vaccination and the potential reduction of the number of doses recommended for some or all recipients. Currently, ACIP recommends a 2-dose HPV vaccine series at age 11–12 years and stipulates that vaccination may begin at age 9 years. Some physicians and families prefer to initiate vaccination routinely at age 9 or 10 years to increase the likelihood of series completion before age 13 years. ACIP is considering aligning with the simplified AAP recommendation that HPV vaccination be completed at age 9 through 12 years. This simplification would also cause clinical decision support tools in immunization information systems to prompt for HPV vaccination beginning at age 9. Next steps This discussion will continue at the June ACIP meeting. Cytomegalovirus (CMV) vaccine (information) Background Infection with CMV is common. Although it usually causes few or no symptoms, it can cause severe disease in immunocompromised people or newborns infected before or at the time of birth. The committee discussed the epidemiology of CMV and initial considerations for the use of a vaccine in development (mRNA-1647, Moderna) to reduce the risk of congenital CMV disease (cCMV). Epidemiology CMV is an underappreciated cause of congenital infection. Its epidemiology is complex. Rates of cCMV differ by country, with more than 16,000 U.S. children born with cCMV each year. Outcomes vary widely among those born with cCMV, ranging from neonatal death (0.5%) to sensorineural hearing loss (5%), cognitive impairment (3%), or motor impairment (1%). Most infants with cCMV have no clinical signs at birth and go undiagnosed but may develop signs of impairment later. The risk of cCMV is highest when the mother experiences her first (primary) infection during pregnancy, and the risk of resulting hearing lost or fetal abnormality is highest when the infection occurs in the first trimester. However, long-term adverse outcomes in the infant may also occur due to primary infection at any point in pregnancy or due to reactivation of a latent infection or reinfection with a new strain during pregnancy. In the United States, about 75% of cCMV infections are due to a primary infection during pregnancy and 25% are due to a non-primary infection during pregnancy. Mothers are often exposed to CMV by an older child in the household. An effective vaccine could reduce the burden of cCMV if it protected susceptible women before pregnancy and through childbearing years. Vaccination of toddlers could indirectly protect their pregnant mothers. Moderna investigational CMV vaccine Moderna presented data on an mRNA CMV vaccine under investigation. The vaccine is given to women of childbearing age as a 3-dose series over 6 months. Phase 1 and 2 study results indicate the vaccine is safe and generates a strong immune response that persists for at least 3 years in study participants. A large phase 3 pivotal efficacy trial is underway among women age 16–40 years, with data anticipated in late 2025. Future studies (e.g., in transplant patients) may inform future decisions about the use of this vaccine. Next steps The CMV workgroup will monitor results and update the full committee as needed. Respiratory syncytial virus (RSV) – maternal/pediatric The committee heard updates on clesrovimab (Merck), a new long-acting monoclonal antibody against RSV infection in infants anticipated to be licensed by FDA for use in infants younger than age 8 months in June 2025. This would provide a second monoclonal antibody option for infants younger than age 8 months in addition to nirsevimab (Beyfortus, Sanofi). Only Beyfortus is licensed and recommended for use in high-risk infants and toddlers through age 19 months entering their second RSV season. Clesrovimab is stored in the refrigerator, like most routine vaccines and Beyfortus. However, while Beyfortus uses a smaller dose for infants weighing less than 5 kg, clesrovimab is administered in the same 105 mg (0.7 mL) dose to all infants younger than age 8 months born during or entering their first RSV season. Infants who receive clesrovimab in their first season may receive Beyfortus in their second season when indicated. Next steps ACIP will make recommendations for use of clesrovimab after the product receives FDA licensure. It is anticipated that the recommendations and clinical considerations for its use will match those for Beyfortus in infants younger than age 8 months born to mothers who did not have effective RSV vaccination with Abrysvo (Pfizer) during pregnancy. Pneumococcal and lyme disease vaccine workgroup updates (information) ACIP’s pneumococcal vaccine workgroup is reviewing evidence to create recommendations for the use of pneumococcal conjugate vaccines (PCV) during pregnancy. It is also evaluating a revision of recommendations for hematopoietic stem cell transplant recipients. An update is planned at the June meeting. Similarly, the Lyme disease vaccine workgroup plans to present information on the epidemiology, burden, and clinical manifestations of Lyme disease at the June meeting. Next meeting The next scheduled ACIP meeting will be held on June 25–26, 2025. Information about past and future ACIP meetings may be found on the ACIP website. Related Links
April 24–30 is World Immunization Week! Promote vaccination to protect people of all ages against vaccine-preventable diseases.
World Immunization Week (WIW) is observed the last week of April. A portion of WHO's press release about WIW appears below.
In its April 17 weekly update, CDC reported 800 confirmed measles cases in 2025, with 94% of cases associated with 10 outbreaks. Most of the cases (751 of 800, 94%) were reported by the Texas Department of State Health Services. There were increases in cases in some states; no new states were added this week. Three people have died; no new deaths were reported this week. A map of 2025 measles cases, as of April 17, appears below.
Journalists seek out Immunize.org experts to help explain vaccines to the public and policy makers. We help the media understand and communicate the complex work vaccinators do. Here are some recent citations.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Website and Clinical Resources
Our readers will find immunization history preserved in Immunize.org’s archive of our periodical publications, dating back to 1994. You can scroll the page shown above to see publication descriptions. Or you can use the links on the far left or far right to jump to specific content. The archive contains the following publications: Recap: HPV vaccination is powerful cancer prevention: three Immunize.org patient handouts on HPV updated with case counts and corrected CDC URLs
With all the talk about measles and influenza, it can be easy to overlook other important childhood vaccinations. Immunize.org offers several resources to help you educate families and adults about HPV vaccination and its critical role in cancer prevention. Immunize.org recently updated three of its patient handouts on HPV with current HPV-associated cancer case counts and updated reference URLs:
Featured Resources
Keep the 2025 immunization schedules at your fingertips! Order laminated 2025 U.S. immunization schedule booklets from Immunize.org.
Laminated booklets of the 2025 U.S. child and adolescent immunization schedule and the 2025 U.S. adult immunization schedule are available now in the Immunize.org shop.
  Pricing: Shop Immunize.org: Laminated Schedules web page to view images and order today! For additional information, call 651-647-9009 or email [email protected]. Related Links
Upcoming Events In-person and virtual: Clinical Care Options hosts “The ABCs of RSV: Implementing the Latest Adult Vaccine Recommendations” on May 16 at 7:45 p.m. (ET) in Denver; CE credit available
Clinical Care Options will host an event titled The ABCs of RSV: Implementing the Latest Adult Vaccine Recommendations, in person and virtually from 7:45–9:15 p.m. (ET) on May 16. The in-person event is open to registered participants at the American College of Physicians (ACP) annual meeting in Denver. Virtual attendance is open to anyone at no charge. Participants will learn best practices for implementing RSV vaccination in clinical practice, including determining vaccine eligibility, explaining RSV risk, addressing logistics, and reducing disparities in vaccine uptake. Virtual: WithinReach and partners host webinar series, Building Immunity, Strengthening Community – A Virtual Training Series on Immunizations for Health Professionals, on June 2–5; CE credit available WithinReach, in partnership with the Washington Department of Health, American Indian Health Commission, and local immunization coalitions, will host a webinar series titled 2025 Building Immunity, Strengthening Community: A Virtual Training Series for Health Professionals, 3:00–5:00 p.m. (ET) on June 2–5.
For more upcoming events, visit our Calendar of Events. |
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