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Immunize.org summarizes ACIP’s October 23–24 meeting with new recommendations for pneumococcal conjugate vaccines, COVID-19 vaccine, and more
The Advisory Committee on Immunization Practices (ACIP) met on October 23–24. During the 2-day meeting, ACIP voted to approve the following recommendations:
Presentation slides are available online. Highlights of the meeting, focusing on vaccines with new recommendations, are provided below. PCV in adults age 50 years and older (vote)
Background Pneumococcal disease is caused by over 100 serotypes of Streptococcus pneumoniae bacteria, although only a subset are responsible for most serious invasive pneumococcal disease (IPD). Three PCV options licensed for adults protect against 15, 20, or 21 serotypes. Additional PCV candidates targeting additional serotypes are in development. Conjugate vaccines produce a superior, more durable immune response to included serotypes compared to the 23-valent pneumococcal polysaccharide vaccine (PPSV23). PCV21 includes 11 serotypes not included in PCV20 and excludes 10 serotypes included in PCV20. Among adults recommended for pneumococcal vaccination, ACIP recommends a single dose of either PCV20 or PCV21 alone or a series of PCV15 followed 1 year later by PPSV23. At its June 2024 meeting, ACIP recommended use of the newly licensed PCV21 in any situation where PCV20 was previously recommended, including all unvaccinated adults age 65 years and older and high-risk individuals age 19 through 64 years. At the October meeting, ACIP weighed lowering the age of routine PCV use from age 65 to age 50 years. Economic models Economic models presented at the meeting were significantly limited by uncertainties in the assumptions made to determine the costs of an expanded age-based recommendation, how long PCV protection persists, and whether an additional dose may be recommended at some later date. In general, introducing PCV20 or PCV21 for all adults at age 50 would prevent disease and save lives in this age group, and costs were felt by the members to be acceptable, even if an additional dose of PCV may be needed at some point in the future. Epidemiologic rationale for lowering the age of routine vaccination An estimated 32–54% of adults age 50 through 64 years already have a risk-based indication for pneumococcal vaccination, and almost 9 of 10 people in this age group who are hospitalized with IPD are among those at risk. Pneumococcal vaccine coverage among those age 50 through 64 years is 37.3%, compared to 69.7% among people age 65 and older. There is a disproportionate burden of IPD among Black adults age 50 and older. The incidence rate of IPD in Black adults beginning at age 50 exceeds the incidence rate among all U.S. adults age 65 years and older. National surveillance data show that PCV21 covers the serotypes that cause about 85% of IPD among adults age 65 and older, compared to about 54% for PCV20. However, among certain adult populations in the western United States (e.g., Alaska, Navajo Nation, Colorado, New Mexico, Oregon), 30% or more of IPD is due to serotype 4, which is included in PCV20, PCV15, and PPSV23, but not PCV21. ACIP’s current guidelines note that those caring for groups disproportionately affected by serotype 4 may choose a serotype 4-containing product, which is among the reasons for not limiting this new recommendation to a single product. CDC and FDA provided surveillance data on extremely rare reports of Guillain–Barré syndrome (GBS) after vaccination with PCV20. Eighteen GBS reports (0.7 cases per million doses distributed) after PCV20 have been reported. CDC and FDA continue to monitor reports, but no additional concerns have been identified, and vaccine recommendations are unchanged. Rationale for lowering the recommended age for vaccination ACIP focused on the relatively high burden of preventable IPD in adults age 50 through 64 years and the fact that it is easier for vaccination providers to implement an age-based recommendation. The Committee emphasized their desire to improve health equity by making it easier to vaccinate people with limited access to health care and to provide protection at an earlier age for Black adults and others who are more likely to develop IPD at younger ages. They acknowledged that an additional dose of PCV may be needed 15 or more years after an initial dose to sustain protection among adults vaccinated at younger ages. Decisions about future doses will be based upon evidence of need. PCV options for this recommendation include all three products licensed for adults: PCV21, PCV20, or PCV15. If PCV15 is used, it needs to be followed 1 year later by a dose of PPSV23. CDC will publish online updated clinical considerations for pneumococcal vaccination detailing schedule options, including options for adults with a history of pneumococcal vaccination. COVID-19 vaccine recommendations for additional doses for the 2024–25 season (vote) Background At its June meeting, ACIP voted to recommend a single dose of 2024–2025 Formula COVID-19 vaccine for all people age 6 months and older, as well as a shared clinical decision-making option for additional doses for people who are moderately or severely immunocompromised. At the October meeting, ACIP considered whether a second dose should be routinely recommended for people at highest risk of serious COVID-19 disease during the 2024–25 season. Despite the demonstrated benefits of COVID-19 vaccination, as of October 12, just 3.7% of children age 6 months through 17 years and 11.7% of adults were up to date with 2024–2025 Formula COVID-19 vaccination. Only 14.1% of parents of children and 19.4% of adults surveyed reported they definitely planned to get the vaccine for their child or themselves. Disease burden among older adults and the immunocompromised From March 2020 through September 2024, adults age 65 years and older accounted for 2 out of 3 adult COVID-19-associated hospitalizations and 4 out of 5 COVID-19-associated in-hospital deaths. Vaccine effectiveness against hospitalization or severe illness wanes considerably within 4–6 months of vaccination, and data show that an additional dose at that time restores protection. Among all age groups, people who are immunocompromised are disproportionately likely to be hospitalized with COVID-19. About 1 in 6 people hospitalized with COVID-19 have an immunocompromising condition, and vaccine effectiveness is also generally lower in this group. Economic models presented indicated that, because COVID-19 viruses circulate year-round, administering COVID-19 vaccine doses every 6 months was likely to have the largest benefit in preventing hospitalizations among people age 65 years and older and those who are moderately or severely immunocompromised. Vaccine safety Robust vaccine safety surveillance over the last 3 years demonstrates that serious adverse events after COVID-19 vaccination are rare. The rare risk of myocarditis and pericarditis, predominately in adolescent and young adult males, has not been observed in older adults. CDC and FDA continue to monitor and evaluate data from safety surveillance systems. Rationale for a 2-dose 2024–25 vaccination strategy Because COVID-19 vaccine-induced protection from hospitalization wanes significantly 4–6 months after vaccination, a second dose of COVID-19 vaccine is needed to protect people at highest risk of severe COVID-19 disease as long as COVID-19 continues to circulate in the United States year-round with semi-annual surges. ACIP members believed it would be most practical to make the same recommendation for adults age 65 years and older and immunocompromised people age 6 months and older. ACIP voted (15–0) for each of three new recommendations:
* The second dose is recommended 6 months after the first dose of 2024–2025 Formula COVID-19 vaccine, with a minimum interval of 2 months.
Special notes were added for previously unvaccinated people age 65 years and older or age 6 months and older with moderate to severe immunocompromise:
Pentavalent MenABCWY vaccine discussion Invasive meningococcal disease (IMD, caused by certain serogroups of Neisseria meningitidis bacteria) is a devastating and extremely rare illness in the United States, occurring at a rate of 3 cases per 1 million people each year. Disease incidence varies by age group and by year. Almost all cases of IMD in the United States are caused by Neisseria meningitidis serogroups B, C, W, and Y. Separate vaccines have been licensed to protect against serogroups A, C, W, Y (MenACWY) and serogroup B (MenB) for years. In 2023, a new pentavalent MenABCWY vaccine (Penbraya, Pfizer) was licensed that includes the MenB component used in Trumenba (Pfizer). Because MenB vaccine is given as a 2- or 3-dose primary series and the same brand must be used for both doses, Penbraya was recommended by ACIP to be used only for people who had an indication for vaccination against both MenB and MenACWY at the same visit and who could complete the MenB series with Trumenba. A second MenABCWY vaccine by GSK is anticipated to be licensed in early 2025 that contains the MenB component used in Bexsero. ACIP will consider use of the GSK MenABCWY vaccine upon FDA licensing. Discussion suggested that interim recommendations for GSK’s MenABCWY vaccine would match the recommendation already made for the Pfizer MenABCWY vaccine. ACIP will consider other adjustments to the overall adolescent meningococcal vaccination schedule later in 2025. Because meningococcal disease is devastating yet extremely rare, and because vaccination protects recipients for a limited period, the cost of meningococcal disease prevention greatly exceeds the costs of other vaccination programs. The ACIP meningococcal workgroup is reviewing the meningococcal vaccination schedule to determine a schedule to prevent the most disease at an acceptable societal cost. Bexsero MenB dosing schedule change Bexsero (MenB-4C, GSK) was licensed in 2015 for people age 10 through 23 years as a 2-dose regimen with a 1-month interval between doses. Further studies showed a somewhat better immune response with a routine dosing interval of 6 months instead of 1 month. FDA licensed this new regimen in August 2024. Going forward, if a second dose of Bexsero is given earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose. ACIP does NOT recommend any additional doses for people who completed Bexsero vaccination under the previously approved schedule. ACIP voted (15–0) for three updates to its MenB recommendation to align the dosing schedule of Bexsero (GSK) with the dosing schedule for Trumenba (Pfizer):
Recommended 2025 Child/Adolescent and Adult Immunization Schedules (vote) Each October, ACIP votes to approve updated versions of the child/adolescent and adult immunization schedules, incorporating into the schedules any changes to ACIP recommendations or clinical considerations made since publication of previous schedules. CDC presented drafts of the 2025 child/adolescent and adult immunization schedules, incorporating new recommendations and making minor changes to harmonize wording between the two schedules. The new 2025 schedules are expected to be published online in November 2024 and to be officially published in MMWR in January 2025. ACIP voted (15–0) to approve the Recommended Child and Adolescent Immunization Schedule, United States, 2025 and the Recommended Adult Immunization Schedule, United States, 2025. Influenza vaccine update (VFC resolution vote) The 2023–24 season vaccine effectiveness (VE) estimates During the 2023–24 influenza season, influenza A(H1N1) was the predominant strain, with lower levels of A(H3N2) and B/Victoria also in circulation. CDC’s end-of-season estimates of 2023–24 influenza VE were similar to interim estimates provided in February. Vaccine effectiveness varies by influenza strain and by outcome (prevention of outpatient visit or hospitalization) and generally declines with recipient age. The results of multiple surveillance systems were provided. Last season’s influenza vaccines reduced the risk of an outpatient visit for influenza illness among children by 56–59% and reduced their risk of hospitalization with influenza by 59–64%. Among adults age 18 through 49 years, VE against any influenza was lower, reducing risk of an outpatient influenza visit by 37–54% and reducing risk of hospitalization by 51–53%. Among adults age 50 through 64 years vaccination reduced risk of an outpatient visit for influenza by 22–44% and reduced risk of hospitalization by 40–48%. Among adults age 65 years and older, vaccination reduced risk of an outpatient influenza visit by 37–40% and reduced risk of hospitalization by 31–36%. Update on highly pathogenic avian influenza A(H5N1) Since March 2024, A(H5N1) has been confirmed in dairy herds in 324 farms across 14 states, and 27 human cases have been reported across five states. The human cases have been clinically mild and all recovered. So far, the virus does not show genetic changes that would help it sustain human-to-human transmission and potentially trigger a pandemic. These A(H5N1) viruses are treatable with available antiviral medications. CDC, along with state and local public health agencies, is conducting surveillance for new cases and monitoring exposed individuals. Refer to the CDC website for updates. At present, the risk to the general public from A(H5N1) remains low. Influenza vaccine VFC vote During its June 2024 meeting, ACIP voted to recommend high-dose and adjuvanted inactivated influenza vaccines (HD-IIV, aIIV), which are both FDA-licensed for age 65 years or older, as options without a preference, for use in solid organ transplant recipients age 18 through 64 years receiving immunosuppressive medications. Because the VFC program includes age 18, the VFC resolution was formally modified to add these products as options for vaccination of solid organ transplant recipients age 18 years. ACIP voted (15–0) to add Fluad (CSL Seqirus) and Fluzone High-Dose (Sanofi) to the influenza VFC resolution to prevent influenza as options for vaccination of solid organ transplant recipients who are age 18 years. Pediatric/maternal RSV (information) ACIP recommends that all infants be protected against severe RSV disease with either maternal RSV vaccine (Abrysvo, Pfizer) or the preventive antibody nirsevimab (Beyfortus, Sanofi). The ACIP reviewed reassuring data supporting the safety of Abrysvo during pregnancy, showing no increased risk for preterm birth or small-for-gestational-age at birth last season. CDC and FDA will continue to monitor vaccine safety data for the vaccine. Merck provided information on its investigational RSV preventive antibody, clesrovimab, which is in the final stages of the FDA review process. Clesrovimab is intended to be used in a manner similar to Beyfortus. ACIP will make recommendations after the FDA licensure decision. Adult RSV (information) At its June 2024 meeting, ACIP recommended that all adults age 75 years and older and those adults age 60 through 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine. The RSV vaccine options are the protein vaccines, Arexvy (GSK) and Abrysvo (Pfizer), or the mRNA vaccine, mResvia (Moderna). Arexvy is also licensed for use in adults age 50 through 59 years, and Abrysvo was recently licensed for use in individuals age 18 through 59 years who are at increased risk of lower respiratory track disease caused by RSV. ACIP’s workgroup is evaluating data and has not yet proposed recommendations for use of these products in people younger than age 60 years. Revaccination of people who have received a single dose of any RSV vaccine is not recommended at this time. The ACIP heard presentations from GSK, Pfizer, and Moderna regarding their products and relevant data on vaccine safety. GSK presented clinical trial follow-up data showing meaningful protection from its RSV vaccination persisted through a third RSV season. In addition, all three manufacturers reported data on the use of their vaccines in immunocompromised individuals. Pfizer provided data indicating its vaccine can be coadministered with other vaccines without reducing vaccine safety or efficacy. A slightly lower immune response after coadministration of the Moderna RSV and high-dose influenza vaccine was reported, but the clinical significance of this finding is unknown. FDA presented updated data indicating that there appears to be a slightly increased but rare risk of Guillain Barré Syndrome (GBS) after receipt of either of the two protein-based vaccines. The risk was estimated at 7–9 cases per million vaccinations. The newer mRNA RSV vaccine has not been associated with GBS but was licensed too recently for a similar evaluation. ACIP members noted that the risk of GBS must be considered in context of the public health benefits of GBS vaccination. Chikungunya vaccine (information) In February 2024, ACIP made recommendations for use of live attenuated chikungunya vaccine (Ixchiq, Valneva) among U.S. travelers and laboratory workers age 18 years and older. The manufacturer expects to submit data soon requesting that FDA lower the age of indication to 12 years. In addition, clinical trials are underway to evaluate Ixchiq in children age 1 through 11 years. Updates were provided on possible licensure of a new, non-live, virus-like particle vaccine (Bavarian Nordic) during 2025 for people age 12 years and older. At future meetings, ACIP will review both vaccines, with anticipated votes on their use in younger travelers, if licensed by FDA, as well as considerations for chikungunya vaccination of residents of U.S. territories with and without current risk of chikungunya transmission. HPV vaccine (information) The HPV vaccine workgroup was reconvened in response to global changes in HPV vaccination policies, including the recent adoption of 1-dose vaccination schedules in some countries, based upon real world evidence of 1-dose effectiveness against cervical cancer and its precursors. CDC briefly reviewed available data at this meeting. The manufacturer of 9-valent HPV (Gardasil 9, Merck) is preparing to conduct prospective randomized clinical trials to evaluate the effectiveness of 1-dose schedules in males and females. The workgroup plans to focus on reviewing evidence to determine if a 1-dose or 2-dose HPV vaccine schedule should be considered for certain age groups. The workgroup also will evaluate changing the wording of its recommended age for HPV vaccination, from the current recommendation for age 11 through 12 years, with the option to begin as early as age 9 years, to a simplified statement that HPV vaccination be given at age 9 through 12 years. Cytomegalovirus (CMV) vaccine (information) The CMV vaccines workgroup was established in anticipation of future licensure of a vaccine for prevention of congenital CMV disease, the most common infectious cause of neurodevelopmental disabilities in U.S. children. Two candidate vaccines are currently in late Phase 3 trials. Mpox vaccine and global situational update (information) ACIP has reformed its mpox vaccine workgroup in response to the current clade 1a and clade 1b mpox outbreaks occurring primarily in the Democratic Republic of the Congo (DRC) and, to a lesser extent, some surrounding African countries. Over 8,000 clade 1 mpox cases have been reported in DRC in 2024. These mpox viruses are different from clade 2b mpox virus that has been causing illness in the United States since 2022. No clade 1 cases of mpox have been reported in the United States, and risk is considered low for U.S. travelers. The risk of transmission to U.S. travelers is primarily through sex while visiting countries with sustained mpox transmission. CDC recommends counseling of travelers to countries with sustained transmission about strategies to reduce risks of mpox exposure and vaccination of travelers who anticipate engaging in activities that put them at risk of exposure during travel to affected countries. The mpox vaccine workgroup plans to review studies on the use of Jynneos vaccine (Bavarian Nordic) in people age 12 through 17 years, currently only permitted under an emergency use authorization, as well as development of consolidated recommendations for use of the vaccine in people age 12 years and older. Next meeting The next scheduled ACIP meeting will be held on February 26–27, 2025, although additional emergency meetings may be announced prior to that time. Information about past and future ACIP meetings may be found on the ACIP website.
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Immunize.org posts its first clinical resource translations in Punjabi, including screening checklists for contraindications to vaccines and "Record of Vaccine Declination"
Immunize.org continues to expand its clinical resource translations with three resources now available in Punjabi. The three translations were generously donated by California’s Fresno County Department of Public Health Immunization Program.
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FDA licenses Pfizer’s RSV vaccine for adults age 18–59 at increased risk for RSV disease; ACIP will consider recommendations for its use at future meeting
On October 22, FDA licensed Abrysvo (Pfizer) to prevent lower respiratory tract disease (LRTD) caused by RSV in adults age 18 through 59 years who are at increased risk.
The 2024–25 U.S. influenza season is underway and now is the time to vaccinate. For the third week of the 2024–25 influenza season, week 42, ending October 19, CDC’s Weekly U.S. Influenza Surveillance Report, FluView, shows low respiratory illness activity nationally. Influenza Vaccination Dashboard
Once again, every United State household can order a free set of four at-home, rapid antigen COVID-19 tests, delivered by the U.S. Postal Service, at CovidTests.gov. Back to top
Immunize.org updates "Hepatitis B Facts: Testing and Vaccination" resource for healthcare professionals
Immunize.org updated its Hepatitis B Facts: Testing and Vaccination resource for healthcare providers. Content was reviewed and several URLs were updated due to recent changes to the CDC website.
"What Is Respiratory Syncytial Virus (RSV)?” Watch the 2-minute answer, part of the Ask the Experts Video Series on YouTube. This week, our featured episode from the Ask the Experts Video Series is What is Respiratory Syncytial Virus (RSV)? The video describes the virus that causes RSV, disease seasonality and symptoms, and people most likely to develop severe RSV.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Website and Clinical Resources
Recap: Print and post one of Immunize.org’s new QR code tables for easy, one-click access to current VISs
Two new resources from Immunize.org now put VISs at your fingertips with simple QR code tables that, when scanned, will always go to the current VIS for any listed vaccine.
Vaccine Information Statements
On October 17, CDC released three updated VISs for the COVID-19 vaccine, RSV vaccine, and cholera vaccine.
Featured Resources UCI Health Infection Prevention and Epidemiology offers free downloadable posters with evidence-based information encouraging COVID-19 and influenza vaccination
UCI Health Infection Prevention and Epidemiology offers free downloadable posters through the Educational Materials to Bring Resilience Against Contagious Events (EMBRACE) project, an initiative funded by the CDC. This series of 12 posters provides evidence-based information to encourage the uptake of COVID-19 and influenza vaccinations. The posters cover essential topics such as vaccine effectiveness, safety, and common myths.  View and download the posters. Notable Publications
“Genomic Surveillance for SARS-CoV-2 Variants: Circulation of Omicron XBB and JN.1 Lineages—United States, May 2023–September 2024” published in MMWR
CDC published Genomic Surveillance for SARS-CoV-2 Variants: Circulation of Omicron XBB and JN.1 Lineages—United States, May 2023–September 2024 on October 24 in MMWR. A portion of the summary appears below. CDC’s national SARS-CoV-2 genomic surveillance program previously detected the emergence and circulation of major variants, including Delta and Omicron. . . . During May 2023–September 2024, SARS-CoV-2 lineages primarily comprised descendants of Omicron XBB and JN.1. Multiple XBB descendants circulated in summer and fall 2023 with immune escape characteristics. JN.1, which was not an XBB descendant, contained substantial genetic differences and became predominant by January 2024. Descendants of JN.1 subsequently emerged. Increases in COVID-19 cases occurred during both variant predominance and cocirculation periods. . . . Given the unpredictable nature of SARS-CoV-2 evolution, continued monitoring for genetic changes and their impact on disease severity and medical countermeasure effectiveness remains essential.
Upcoming Events
Today! Virtual: American Lung Association offers webinar titled “Respiratory Virus Immunizations for Adults with Chronic Medical Conditions” on October 30 at 1:00 p.m. (ET).
The American Lung Association will offer a webinar titled Respiratory Virus Immunizations for Adults with Chronic Medical Conditions at 1:00 p.m. (ET) on October 30. This webinar will focus on the recommendations for the 2024–25 respiratory season and the implications of respiratory pathogens on adults living with chronic medical conditions. The webinar will also highlight prevention strategies, vaccination recommendations, where to get vaccinated, and more. Today and tomorrow! Virtual: Questions about our website? Register for the next Immunize.org Website Office Hours on October 30 at 4:00 p.m. (ET) or October 31 at 12:00 p.m. (ET). If you would like to learn simple tips and tricks for using our website efficiently, please register for one of our Website Office Hours sessions today, Wednesday, October 30 at 4:00 p.m. (ET) or tomorrow, Thursday, October 31 at 12:00 p.m. (ET). Mark your calendar for our future Immunize.org Website Office Hours sessions. Due to the upcoming holiday season, we will hold only one pair of sessions in November and one pair in December. Back to top
Tomorrow! Virtual: National Vaccine Program offers webinar and listening session, “Vaccines National Strategic Plan: Progress, Challenges, and Future Strategies,” on October 31 at 1:00 p.m. (ET).
The HHS Office of Infectious Disease and HIV/AIDS Policy, which coordinates the National Vaccine Program, will offer a webinar and listening session titled Vaccines National Strategic Plan: Progress, Challenges, and Future Strategies, 1:00–2:30 p.m. (ET) on October 31. The webinar will discuss the next iteration of the Vaccines National Strategic Plan. Attendees can offer suggestions to enhance vaccine planning over the next 5 years. Register for the webinar.For more upcoming events, visit our Calendar of Events. |
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