Immunize.org summarizes ACIP’s August 25–26 meeting with recommendations for clesrovimab and 2025–26 influenza vaccine
In an unprecedented move, on June 9 the Secretary of Health and Human Services dismissed all 17 voting members of the Advisory Committee on Immunization Practices (ACIP). On June 11, he named eight new voting members to begin serving before the Committee’s June meeting. After the withdrawal of one appointee during a financial holdings review, the committee consisted of seven individuals when the meeting convened.
The newly appointed ACIP members met on June 25–26. During the 1.5-day meeting, ACIP voted on the following topics:
- Recommendation of the long-acting monoclonal antibody clesrovimab as an option for RSV prevention in infants, and an accompanying VFC vote
- Influenza vaccine recommendations for the 2025–26 season, including use of influenza vaccines containing thimerosal as a preservative
The Committee also received updates on COVID-19, chikungunya, measles-mumps-rubella-varicella (MMRV), and anthrax vaccines. An anticipated vote on COVID-19 vaccines for the 2025–26 season was not held.
Presentation slides are available online. Video recordings of the ACIP’s June 25 session and the June 26 session are archived at YouTube. Highlights of the meeting appear below.
New workgroups (announcement)
ACIP workgroups traditionally review relevant data and develop vaccine recommendation options for consideration by the full Committee. During his introductory statements, newly-appointed ACIP Chair Martin Kulldorff announced two new workgroups. They will:
- examine CDC’s Recommended Child and Adolescent Immunization Schedule to re-evaluate the number of recommended vaccines, potential vaccine interactions, the cumulative impact of vaccine ingredients, and the relative timing of different vaccines and
- review vaccines whose recommendations have not been reconsidered in more than 7 years (e.g., hepatitis B and MMR vaccines).
RSV vaccines: maternal/pediatric (information and vote)
Background
RSV is the leading cause of hospitalization in U.S. infants, with 2%–3% of young infants hospitalized annually. Approximately 80% of RSV-hospitalized infants have no underlying medical conditions. Most (68%) U.S. infants are infected in the first year of life, and nearly all (97%) have been infected by age 2 years.
In 2023, ACIP issued recommendations on use of two products to prevent RSV disease in infants:
Uptake
CDC staff reported that 57% of infants born from April 2024 through March 2025 were protected from RSV by maternal vaccination or receipt of nirsevimab. The number of birthing hospitals enrolled in the Vaccines for Children (VFC) program increased substantially during this time, greatly expanding access to nirsevimab.
Impact
CDC presented information from two U.S population-based surveillance networks
demonstrating a greater than 30% reduction in RSV-associated hospitalizations (38% in RSV-NET and 31% in the New Vaccine Safety Network among children age 0 through 7 months in 2024–25 compared to RSV seasons before product introduction. These reductions were greatest (46%–47%) among infants age 0 through 2 months, the group at highest risk of hospitalization.
Safety
Safety studies after maternal vaccination showed no increased risk for most outcomes, including preterm birth or stillbirth. A small association was found between vaccination and hypertensive disorders of pregnancy (HDP), but the workgroup and the American College of Obstetricians and Gynecologists agreed this was not a concern, in part because the severity of HDP was similar between vaccinated and unvaccinated women based on rates of Caesarean section, admission after birth hospitalization, or length of stay.
Reassuring data was presented on the safety profile of nirsevimab use. Among 74,000 neonates who received nirsevimab across two seasons, there was no evidence of increased risk of seizures, immune thrombocytopenic purpura, drug reactions, fever, or sepsis. There were no cases of anaphylaxis. A small number of non-anaphylactic allergic reactions were seen. Simultaneous administration of nirsevimab with other vaccines did not result in increased rates of adverse events.
Clesrovimab
On June 9, FDA approved clesrovimab (Enflonsia, Merck), a second long-acting preventive antibody against RSV infection in infants younger than age 8 months. Safety and clinical trial data for clesrovimab were presented at the April 2025 ACIP meeting. The dosage for nirsevimab varies based on a child’s body weight, while clesrovimab is administered as a single dose without regard to weight. Clesrovimab is stored in the refrigerator. At this time, clesrovimab is not licensed for use during a child’s second RSV season. CDC indicated that infants who receive clesrovimab in their first season may receive nirsevimab in their second season when indicated.
ACIP members discussed the benefits of having two RSV preventive antibody products available. These include having options if resistance develops with either product, reducing the risk of a shortage if either product has an insufficient supply, and the possibility of competitive pricing. However, it may be challenging for providers who prefer to stock a single RSV antibody, as clesrovimab is not licensed for a child’s second RSV season. Either nirsevimab or clesrovimab may be used for infants younger than age 8 months born during or entering their first RSV season who are not protected by maternal vaccination.
ACIP voted (5 yes, 2 no) to recommend infants age younger than age 8 months born during or entering their first RSV season who are not protected by maternal vaccination receive one dose of clesrovimab.
In a separate vote, ACIP voted unanimously (7–0) to include clesrovimab in the Vaccines for Children program.
Influenza vaccines (information and votes)
Flublok update
Recombinant influenza vaccine (Flublok, Sanofi) has been licensed since 2013 for use in persons age 18 years and older. In May 2025 FDA expanded the age indication of the vaccine to include children and adolescents age 9 through 17 years. Sanofi provided a review of the company’s immunogenicity and safety studies showing the immune response and safety profile of the vaccine was comparable in the 9–17 year and adult age groups.
2024–25 influenza season
For the first time since 2017–18, the 2024–25 influenza season was classified as “high severity” across all indicators, with an estimated 56 million illnesses, 25 million medical visits, and 770,000 hospitalizations. In addition, the 2024–25 influenza season had the highest cumulative influenza-associated hospitalization rate since the 2010–11 season. Approximately 16% of hospitalized patients required ICU admission and 6% required invasive mechanical ventilation. The greatest burden of influenza disease was seen in people age 65 years and older. Influenza vaccine coverage varied by age group, ranging from 35%–71%. Preliminary information for 2024–25 indicates influenza vaccination prevented an estimated 12 million illnesses, 5.7 million hospitalizations, and 240,000 deaths. As of June 7, 246 influenza-associated pediatric deaths have been reported for the season, the highest number of pediatric deaths reported in any non-pandemic influenza season since the condition became reportable in 2004.
Thimerosal in influenza vaccines
Thimerosal is an ethylmercury-containing compound used since the 1930s in the United States as a preservative in multi-dose vials (MDVs) to help kill bacteria that can be introduced into a vial as needles puncture the vial stopper and doses are withdrawn. In 1999, FDA requested that all vaccine manufacturers remove thimerosal from childhood vaccines. This was done as a precautionary measure, not due to evidence of harm, but to reduce an infant’s overall exposure to mercury-containing compounds. By 2002, childhood vaccines licensed and recommended in the United States have been thimerosal-free. MDVs of influenza vaccine, primarily intended for adult vaccination campaigns, represent approximately 5% of influenza vaccine doses in the United States. Studies conducted since 1999 overwhelmingly confirmed that thimerosal in vaccines does not pose a health risk. Despite this, some groups continue to express concern about thimerosal, and the Committee heard a presentation highlighting these concerns. No presentation describing the substantial body of peer-reviewed evidence showing no harm from thimerosal was given. A briefing document, Thimerosal-Containing Vaccines and Neurodevelopmental Outcomes: Review of the Evidence, was posted on the ACIP website on June 24, but removed the next day. This extensively referenced document concluded: “Considering the breadth of evidence and consistency in results from multiple population-based studies conducted in several countries with various study designs, the evidence does not support an association between thimerosal-containing vaccines and autism spectrum disorder or other neurodevelopmental disorders.”
2025–26 recommendations
ACIP voted (6 yes, 1 abstain) to reaffirm recommendations for the 2025–26 influenza season for routine annual influenza vaccination of all people age 6 months and older who do not have contraindications.
In three separate votes, ACIP voted (5 yes, 1 no, 1 abstain) that seasonal influenza vaccines should be provided only in single dose formulations that are free of thimerosal as a preservative for (1) children age 18 years and younger, (2) pregnant women, and (3) all adults.
The 2025–26 influenza vaccines will include a new A/H3N2 strain and the same A/H1N1 and B/Victoria strains as the previous season. All U.S. seasonal influenza vaccines marketed for 2025–26 will be trivalent. Product options will include live attenuated influenza vaccine (FluMist, AstraZeneca) for self- or caregiver-administration.
COVID-19 vaccines (information only, no vote taken)
COVID-19 disease burden
COVID-19 continues to cause hospitalizations and death in the United States. CDC’s preliminary estimates from October 1, 2024, through June 7, 2025, indicate COVID-19 resulted in 9.8–16.1 million illnesses, 2.4–3.8 million outpatient visits, 270,000–440,000 hospitalizations, and 32,000–51,000 deaths. Long COVID also continues to be a significant public health issue. In 2023, 8.4% of adults and 1.4% of children reported having had long COVID.
COVID-19-associated hospitalizations from July 2024 through June 2025 were highest among adults age 75 years and older. Strikingly, rates of hospitalization in infants younger than age 6 months (268/100,000) were comparable to those among adults age 65 through 74 years (266/100,000). While most hospitalized adults had at least one underlying medical condition, 71% of hospitalized children younger than age 6 months and 54% of children age 6 through 23 months had no identified underlying medical condition before hospitalization. Half (50%) of SARS-CoV-2-positive pregnant women hospitalized from April 2024 through March 2025 with COVID-19 symptoms on admission had no underlying medical conditions. Approximately 1 in 4 hospitalized children younger than age 18 years required ICU admission. During 2024–25, 89% of COVID-19 vaccine-eligible children and adolescents hospitalized with COVID-19 had not received the most recently recommended COVID-19 vaccine. Similarly, most adults hospitalized with COVID-19 had received no COVID-19 vaccine since July 2023.
COVID-19-related mortality decreased in 2024–25 compared to previous seasons. More than 75% of deaths occurred in adults age 75 years and older.
Vaccine coverage and effectiveness
COVID-19 vaccination coverage for older adults improved in 2024–25 compared to previous seasons, but overall coverage remains below previous years in all age groups. Coverage was estimated at 47%, 43%, and 23% for people age 75 years or older, 65 through 74 years, and 18 through 64 years, respectively. Approximately 13% of children age 6 months through 17 years were up to date with COVID-19 vaccination in April 2025. CDC presented data from several surveillance systems demonstrating the benefits of an in-season COVID-19 vaccination in reducing emergency department/urgent care visits in children, hospitalization in infants younger than age 5 months whose mothers were vaccinated, and both types of events in adults.
Vaccine safety
Extensive monitoring continues to support the overall safety of COVID-19 vaccines. Most reported adverse events are similar to those seen with other vaccines. An increased risk of myocarditis and pericarditis was seen after mRNA COVID-19 vaccination among adolescent and young adult males, most often after the second monovalent or first booster dose of mRNA COVID-19 vaccine. CDC follow-up studies show that 90% people for whom this adverse event was reported had fully or probably fully recovered by 1 year after vaccination. On June 25, FDA revised the package inserts for Comirnaty (Pfizer) and Spikevax (Moderna) regarding this rare adverse event. See accompanying story in this issue.
The majority (70%) of COVID-19 vaccine reports to the Vaccine Adverse Events Reporting System (VAERS) in children younger than age 12 years were vaccine administration errors likely due to the complexity of the recommendations. Multiple studies of COVID-19 vaccination in pregnant women showed no increased risk in maternal, pregnancy, or infant outcomes.
Chikungunya vaccines (information)
Due to time limitations, CDC provided an abbreviated presentation on the Evidence to Recommendations (EtR) developed by the chikungunya vaccine workgroup. The full presentation, including information on chikungunya disease severity and epidemiology, is available online.
Two chikungunya vaccines, a live attenuated vaccine (Ixchiq, Valneva) and a virus-like particle vaccine (Vimkunya, Bavarian Nordic), are licensed for use in the United States. Recommendations for these vaccines apply to certain travelers and laboratory workers at elevated risk of exposure. The chikungunya vaccine workgroup is continuing discussions on potential recommendations for these vaccines in U.S. territories and states where a risk of chikungunya virus transmission exists.
After several reports of serious cardiac and neurologic adverse events in older adults who received the live-attenuated vaccine (Ixchiq), on May 9 FDA and CDC recommended a temporary pause in use of this vaccine in people age 60 years and older while these reports are being investigated.
Anthrax vaccine (information)
Anthrax vaccine adsorbed, adjuvanted (Cyfendus, Emergent BioSolutions) was licensed in July 2023 for post-exposure prophylaxis after exposure to Bacillus anthracis in adults age 18 to 65 years. An anthrax vaccine workgroup is reviewing potential recommendations for domestic use of this vaccine. Results of their discussion will be reported at future ACIP meetings.
MMRV vaccine (information)
ACIP chair Martin Kuldorff reviewed the data for the slightly increased risk of febrile seizures in young children following receipt of MMRV vaccine (ProQuad, Merck) compared to separate doses of MMR and varicella. Additional discussion on this topic may occur at future ACIP meetings.
Next meeting
The next scheduled ACIP meeting will be held October 22–23, 2025, although the ACIP Meeting Information web page notes that additional meetings may be held in September or October. Information about past and future ACIP meetings may be found on the ACIP website.
Related Links
Professional societies and immunization stakeholders react to recent ACIP developments
NFID posted a compilation of statements from professional societies and long-time immunization stakeholders regarding the June ACIP meeting and related events.
Other relevant statements include these:
Immunize.org welcomes its newest educational website, LetsGetRealAboutVaccines.org, to provide credible, plain-language information about routine pediatric vaccines Let’s Get Real, launched by the U.S. Department of Health and Human Services (HHS) in 2024, aimed to boost vaccine confidence. The campaign was canceled in early 2025 and Immunize.org acquired the content to continue providing this clear and accurate information. Content is offered in English and Spanish (Hablemos en serio).
Trust in experts has declined. LetsGetRealAboutVaccines.org (Let’s Get Real) highlights that most parents want their children protected from vaccine-preventable diseases and uses stories to convey important facts. It uses plain language to debunk misinformation. Let’s Get Real explains the scientific complexities of immunization through understandable language and graphics.
LetsGetRealAboutVaccines.org was researched and reviewed by medical, public health, and communications experts at CDC, FDA, and other HHS agencies to ensure the content is accurate, timely, and easy to understand. The development team worked with parents to find the right tone and focus on key issues. Immunize.org now takes responsibility for keeping Let’s Get Real up to date.
Take a look at LetsGetRealAboutVaccines.org and see for yourself. Immunize.org welcomes feedback at www.immunize.org/about/org/contact.
The website is available in English and Spanish with in-depth content on:
- Vaccine-preventable diseases and the vaccines that prevent them
- Vaccine science and safety
- Separating facts from fiction
Immunize.org is thrilled to host and manage LetsGetRealAboutVaccines.org. We encourage our partners to leverage its resources to increase vaccine confidence.
ACOG issues statement on COVID-19 vaccination during pregnancy, as well as a social media toolkit A portion of a statement regarding COVID-19 vaccination during pregnancy from the American College of Obstetricians and Gynecologists (ACOG) appears below.
Now more than ever, it’s critical to continue to recommend the routine administration of COVID-19 vaccines during pregnancy. Vaccine uptake data since the onset of the COVID-19 pandemic have consistently demonstrated that mRNA vaccines are safe and effective when given during pregnancy. Substantial scientific evidence continues to favor vaccination during pregnancy as the best way to prevent severe illness; extend protection to the pregnant patient, the fetus, the growing family, and the community; and strengthen immunization as a critical component of maternal care.
In addition, ACOG released a social media toolkit, with ready-to-use messaging to help inform patients and clinicians about recommended vaccines for pregnant patients. Access and share their graphics, and resources to support maternal immunization with your networks and to keep patients informed.
FDA updates warnings in mRNA COVID-19 vaccine labeling regarding myocarditis and pericarditis
On June 19, FDA revised the wording of warnings in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis. A portion of their Safety Communication appears below. These risks and warnings have been widely discussed since 2021.
FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023–2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine. FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.
The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.
Related Links
“Why Is Pneumococcal Vaccine Now Recommended at Age 50 Instead of Age 65?” Watch the 2-minute synopsis, part of the Ask the Experts Video Series on YouTube. This week, our featured episode from the Ask the Experts Video Series is titled Why Is Pneumococcal Vaccine Now Recommended at Age 50 Instead of Age 65? The video highlights the rationale behind this recommendation, to address the substantial burden of preventable, serious invasive pneumococcal disease (IPD) and pneumococcal pneumonia in people age 50 through 64 years.
The 2-minute video is available on our YouTube channel, along with our full collection of quick video answers to popular Ask the Experts questions.
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise.
IZ Express works hard to keep our 52,000+ readers up to date on evidence-based vaccine information each week; encourage all vaccination providers to subscribe
Now more than ever, vaccinators need accurate, up-to-date immunization news at their fingertips. Encourage your coworkers to subscribe to IZ Express, the weekly e-newsletter from Immunize.org. It’s free!
IZ Express alerts our readers to the week’s important vaccine developments and features:
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Thank you for helping us get the latest vaccine news to every clinical and public health professional who needs to know.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Website and Clinical Resources
Summary: Updated Immunize.org clinical resources released in May and June
IZ Express regularly provides readers with information about Immunize.org’s new and updated educational materials for healthcare professionals and handouts for patients. All Immunize.org materials are free to distribute.
In case you missed them during recent weeks, updates were made to these helpful materials:
Immunize.org Updated Materials for Clinicians
Standing Orders Templates for Administering:
Materials Supporting Immunization Services:
Immunize.org Web Pages:
Related Links
- Immunize.org: Clinical Resources A–Z main page to see educational materials sorted by category
- For additional support, view these resources from Immunize.org:
Vaccine Information Statements
Summary: VISs released in May
IZ Express regularly provides readers with information about VISs and translations of VISs.
On May 29, 2025, CDC released two VISs, PPSV (Pneumococcal Polysaccharide) vaccine VIS and PCV (Pneumococcal Conjugate) vaccine VIS.
Two clinical resources related to VISs were also updated:
For additional support, view these resources from Immunize.org:
4th of July We the People Vax campaign is available for download
We the People Vax, sponsored by the Indiana Immunization Coalition, is a group of coalitions and health organizations raising awareness of the patriotism of vaccinating. Their campaigns include one designed for America’s 249th Independence Day.
Their 4th of July campaign includes:
- An MP4 video to share as a reel on Facebook and Instagram or as a post on any social media platform
- One static JPG graphic
- Sample messages for easy and effective sharing
America’s founding is in part due to the success of immunization. Forces of the Continental Army, weakened by repeated outbreaks of smallpox, lost the battle of Québec City in December 1775 and were forced to retreat to Fort Ticonderoga. Later, George Washington ensured his troops were healthy enough to fight the British by having soldiers in the Continental Army inoculated against smallpox. Today, vaccines protect our military, police forces, frontline workers, schools, communities, and families.
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So many adults need vaccines. Order laminated 2025 U.S. adult immunization schedule booklets from Immunize.org.
Laminated booklets of the 2025 U.S. adult immunization schedule are still available in the Immunize.org shop. The 2025 child and adolescent schedule booklets sold out.
The schedules are available online as PDFs from CDC at no cost. Immunize.org’s laminated booklets are ideal for use in any busy healthcare setting where vaccines are given.
Adult Booklets
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2–4 copies: $9.50 each
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Visit the Shop Immunize.org: Laminated Schedules web page to view images and order today!
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Related Links
Needle anxiety is common at any age. Use Immunize.org’s clinical resources to offer a positive vaccination experience. In Clinical Resources: Improving the Vaccination Experience, Immunize.org provides print and video tools to create a positive vaccination experience and ease injection anxiety in children and adults. Links to additional resources from trusted partner organizations are also provided.
The web page links to eight printable resources on addressing vaccination anxiety (four for providers, four for recipients—also available in Spanish), two in-depth webinars, and six brief videos (listed below). As with all Immunize.org resources, these are free to download, link, copy, and share.
The video topics include:
Related Link
"Global, Regional, and National Trends in Routine Childhood Vaccination Coverage from 1980 to 2023 with Forecasts to 2030: A Systematic Analysis for the Global Burden of Disease Study 2023" published in Lancet
In its June 24 issue, Lancet published Global, Regional, and National Trends in Routine Childhood Vaccination Coverage from 1980 to 2023 with Forecasts to 2030: A Systematic Analysis for the Global Burden of Disease Study 2023. The interpretation section appears below.
Our estimates of current vaccine coverage and forecasts to 2030 suggest that achieving IA2030 [Immunization Agenda 2030] targets, such as halving zero-dose children compared with 2019 levels and reaching 90% global coverage for life-course vaccines DTP3, PCV3, and MCV2, will require accelerated progress. Substantial increases in coverage are necessary in many countries and territories, with those in sub-Saharan Africa and south Asia facing the greatest challenges. Recent declines will need to be reversed to restore previous coverage levels in Latin America and the Caribbean, especially for DTP1, DTP3, and Pol3. These findings underscore the crucial need for targeted, equitable immunisation strategies. Strengthening primary health-care systems, addressing vaccine misinformation and hesitancy, and adapting to local contexts are essential to advancing coverage. COVID-19 pandemic recovery efforts, such as WHO's Big Catch-Up, as well as efforts to bolster routine services must prioritise reaching marginalised populations and target subnational geographies to regain lost ground and achieve global immunisation goals.
Virtual: Register for Immunize.org Website Office Hours. Ask questions and learn about the LetsGetRealAboutVaccines.org website on July 9 at 4:00 p.m. (ET) or July 10 at 12:00 p.m. (ET). Recorded sessions archived.
To learn simple tips and tricks for using our website efficiently, please register for our next set of Website Office Hours on Wednesday, July 9 at 4:00 p.m. (ET) or Thursday, July 10 at 12:00 p.m. (ET). The same content will be covered in both sessions.
We will open each 45-minute session with a short, live demonstration on navigating Immunize.org’s newly launched Let’s Get Real About Vaccines website. Please see the story above for more about this exciting development.
Register today for Immunize.org Website Office Hours (content is the same for both):
The archive of previous Website Office Hours content is posted at Immunize.org’s "Webinars & Videos" page. These archived programs include Ask the Experts; Clinical Resources; Vaccine Information Statements (VISs); Affiliated Websites; Images, Webinars, Videos, & Social Media; News & Updates; Official Guidance Part 1 & 2; Publication Archives, Vaccine Timeline, & About Us; Travel Vaccines, Vaccine Confidence, & Addressing Concerns; and Vaccines A–Z.
See our Calendar of Events for future Immunize.org Website Office Hours.
Virtual: North Dakota State University Center for Immunization Research and Education hosts webinar titled “The Real Science of Vaccines and Autism” on July 16 at 1:00 p.m. (ET); CME available The North Dakota State University Center for Immunization Research and Education will host a webinar titled The Real Science of Vaccines and Autism, from 1:00–2:00 p.m. (ET) on July 16. Speakers will include the Autism Science Foundation’s chief science officer, Alycia Halladay, PhD.
Attendees will learn about the origins of the vaccine-autism myth, the robust scientific evidence that disproves a connection, and practical tools to address persistent myths with clarity and confidence.
Free CME will be provided to live attendees.
Register for the webinar.
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