IZ Express #1,721: Summary of Oct 25–26 ACIP meeting, nirsevimab prioritization, and more

ACIP met on October 25–26. The meeting included votes on use of pentavalent meningococcal and mpox vaccines and their inclusion in the Vaccines for Children (VFC) program. ACIP approved the recommended immunization schedules for 2024. The committee also received information on vaccines against RSV, influenza, chikungunya, dengue, COVID-19, and pneumococcal disease. Presentation slides are available online. Highlights of the meeting are provided below.

Pentavalent meningococcal vaccine (MenABCWY) for use with adolescents and young adults (vote)
On October 20, FDA licensed Penbraya (Pfizer) pentavalent meningococcal vaccine (including serogroups A, B, C, W, and Y) for use in people age 10 through 25 years. This intramuscularly administered vaccine is prepared by reconstituting the lyophilized MenACWY powder with MenB suspension (the same type of MenB vaccine as Pfizer’s Trumenba product. Penbraya is the first FDA-licensed MenABCWY vaccine. A similar vaccine from GSK incorporating the Bexsero MenB antigens is in development. Of note, the two MenB vaccines are not interchangeable. A primary series and any future MenB booster doses must be of the same brand to be effective.

Due to changes in meningococcal disease epidemiology and the limited duration of protection provided by MenB vaccines, the ACIP Meningococcal Vaccine Work Group plans to evaluate and consider changes to the entire adolescent meningococcal vaccine schedule during 2024, with a vote planned in early 2025, sometime after an FDA-licensure decision about the GSK MenABCWY product. Although some ACIP members advocated postponing a decision on use of Penbraya until that time, provisions in federal law require ACIP to consider a licensed product without delay.

ACIP reviewed the vaccine using its Evidence-to-Recommendations framework and an economic analysis indicating use of MenABCWY when both MenACWY and MenB are due would be cost saving relative to the cost of two doses of MenACWY (routinely recommended at age 11 through 12 years and at age 16 years) plus the cost of two doses of MenB (recommended based upon shared clinical decision-making, preferably at age 16 to 18 years) in terms of reducing the burden of invasive meningococcal disease in adolescents.

ACIP reviewed multiple options in which the pentavalent meningococcal vaccine could be used within the existing schedule. After an extensive discussion, the group voted (10–4) to approve the following statement:

Pfizer’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the same visit for:

The members opposed to this narrow decision generally favored a more flexible option to also allow for its use when a second dose of MenB vaccine is due at least 6 months after the first dose, in accordance with its licensed indication, given that this option was also cost saving compared to giving two MenACWY and two MenB doses separately. Additional considerations on use of this vaccine will be included when the final recommendations are published. ACIP also approved inclusion of MenABCWY vaccine in the VFC program for VFC-eligible children indicated to receive both MenACWY and MenB vaccine. Recommendations may be updated when ACIP re-evaluates the meningococcal schedule.

Mpox vaccine (vote)
Since the global mpox outbreak began in May 2022, over 30,000 cases and 54 deaths have occurred in the United States. The primary vaccine (Jynneos, Bavarian Nordic) used to combat the outbreak is FDA-licensed for age 18 years and older as a 2-dose, subcutaneous vaccine. It is available only from the U.S. Strategic National Stockpile: it is not distributed in the commercial market. Due to the initial short supply of Jynneos and the need to vaccinate people younger than age 18 years, in August 2022, FDA issued an emergency use authorization (EUA) allowing Jynneos (1) to be given subcutaneously to individuals younger than age 18 years at high risk of infection, and (2) to be administered intradermally to people age 18 years and older during periods of insufficient vaccine availability.

ACIP reviewed the current epidemiology of mpox in the United States, noting that community transmission continues with one to five cases reported each week, including some among vaccinated people. Mpox cases reported in people who have been vaccinated are generally associated with milder illness, including fewer hospitalizations and a lower number of lesions than in persons who had not been vaccinated. Most cases continue to occur in men who have sex with men and their close contacts.

An estimated 38% of the at-risk population in the United States has received one dose of Jynneos vaccine, and 24% have received both recommended doses. Vaccine uptake has slowed dramatically and Jynneos supply is ample. Disease modeling experts suggest that, without ongoing vaccination of populations at risk, transmission of mpox will continue, punctuated by sporadic outbreaks.

ACIP voted unanimously to recommend vaccination with the 2-dose Jynneos vaccine series for people age 18 years and older who are at risk for mpox. The at-risk population is defined as:

Gay, bisexual, and other men who have sex with men, transgender people, or nonbinary people who, in the past 6 months, have had one of the following:
- A new diagnosis of one or more sexually transmitted diseases
- More than one sex partner
- Sex at a commercial sex venue
- Sex in association with a large public event in a geographic area where mpox transmission is occurring
Sexual partners of persons with the risks described above
Persons who anticipate experiencing any of the above

ACIP also approved addition of this vaccine to the VFC program for eligible individuals age 18 years. This recommendation will be added to the 2024 recommended adult immunization schedule. Clinical trials are underway to evaluate Jynneos in at-risk adolescents age 12 through 17 years to support a licensed indication. Currently, adolescents at risk for mpox may be vaccinated under the EUA. Bavarian Nordic intends to proceed with making Jynneos commercially available in the United States to increase access to the product. ACIP plans to reassess its recommendation in light of the epidemiology of mpox in 2 to 3 years.

2024 adult and child/adolescent recommended immunization schedules (vote)
ACIP reviewed extensive proposed changes to the 2024 child/adolescent and adult recommended immunization schedules. The schedules provide a visual representation of ACIP recommendations; they do not change recommendations.

To accommodate recommendations for nirsevimab (a monoclonal antibody) on the 2024 child/adolescent schedule, the title has been revised to refer to “vaccines and other immunizing agents.” In addition, the 2024 schedules will include an addendum page to list updates to the schedule for new recommendations added by ACIP during the year after its publication.

ACIP voted unanimously to approve the updated schedules. CDC plans to move up publication of the 2024 schedules to November 2023 (instead of February 2024) to allow additional time for healthcare provider education and the logistical steps needed to implement insurance coverage.

Influenza vaccine safety (information)
ACIP reviewed reassuring evidence supporting the safety of influenza vaccination during pregnancy and when coadministered with other vaccines. A post-marketing study presented by Seqirus on use of Flucelvax during pregnancy provided additional information supporting the benefits and safety of using influenza vaccine during pregnancy.

The committee also reviewed the rationale behind the planned removal of the influenza B/Yamagata antigen from influenza vaccines, returning to a trivalent product (two influenza A strains and one influenza B/Victoria) in the United States as early as the 2024–25 season. Global surveillance systems indicate no circulation of influenza B/Yamagata since 2020. Selection of next season’s influenza vaccine components for the northern hemisphere will occur in spring 2024.

RSV vaccine safety (information)
In June 2023, ACIP voted to recommend that adults age 60 years and older may receive RSV vaccine using shared clinical decision making, taking into account patient health status and preferences. In the brief time since introduction, vaccine safety surveillance systems have not identified any safety issues of concern.

ACIP discussed the potential lowering of the vaccine age indication for the GSK vaccine (Arexvy) to include people age 50 through 59 years at increased risk for severe RSV illness. GSK presented ongoing studies that indicate the vaccine’s safety and efficacy within this age group can be inferred, including for people with underlying medical conditions.

At a later date, ACIP’s RSV Work Group will provide information to the full committee for consideration of use of this vaccine in younger (under age 60 years) high risk groups.

Chikungunya vaccine (information)
Chikungunya is a mosquito-borne virus capable of large-scale outbreaks. Complications of chikungunya infection include severe and persistent joint pain. An FDA licensure decision on Valneva’s one-dose live attenuated vaccine is expected in November 2023. At this meeting, members received updates on the potential benefits of chikungunya vaccination in certain travelers and laboratory workers who handle chikungunya viruses. Because it is a non-routine vaccine indicated for travel or occupational risk, a cost-effectiveness analysis was not performed. A vote on chikungunya vaccine recommendations is expected during the February 2024 ACIP meeting.

Dengue vaccine (information)
ACIP heard information about a dengue vaccine (TAK-003, Takeda) that was under consideration for FDA licensure in the United States and was being evaluated by the ACIP Dengue Work Group until the manufacturer voluntarily withdrew it from consideration. Dengue disease is endemic in six U.S. territories. One vaccine, Dengvaxia (Sanofi), is licensed and recommended for use in seronegative adolescents in these territories, but it has had very limited uptake.

COVID-19 vaccines (information)
In fall 2022, CDC reported a possible risk for ischemic stroke in some individuals age 65 years and older following receipt of Pfizer-BioNTech bivalent mRNA COVID-19 vaccine. Since that time, multiple global studies of this question have yielded inconsistent results, with most finding no association. CDC and other safety experts have concluded that these inconsistent and inconclusive results do not indicate that any change in policy is needed. Additional issues may have contributed to the fall 2022 findings, including early and intense influenza activity. Influenza infection increases the risk of stroke. CDC will continue to conduct safety monitoring of this issue and provide updates to ACIP.

CDC also presented updates on the transition of COVID-19 vaccine to the commercial market. Updated 2023–2024 formula COVID-19 vaccines are now available to most people at no cost, either through private health insurance, Medicare, Medicaid, VFC, or CDC’s Bridge Access Program, which provides vaccine for adults who are uninsured or whose insurance does not cover COVID-19 vaccine.

In the first month of availability, 7.1% of adults and 2% of children younger than age 18 years reported receiving the updated (2023–2024 Formula) vaccine since September 14. Despite the clear benefits of vaccination, demand is not high. In CDC surveys, just 25% of adults report definitely planning to get the vaccine, while just 34% of parents report that they definitely plan to vaccinate their children.

Pneumococcal vaccine research (information)
ACIP’s Pneumococcal Vaccine Work Group is continuing to review information on candidate pneumococcal vaccines in advanced stages of development that contain serotypes not included in currently available pneumococcal vaccine formulations.

Next meeting
The next scheduled ACIP meeting will be held on February 28–29, 2024, although additional emergency meetings may be announced before that time. Information about past and future ACIP meetings may be found on the ACIP website.

Related Links

ACIP main page for content from previous meetings, as well as information about future meetings
CDC: ACIP Presentation Slides: June 21–23 Meeting web page

In the context of limited supply during the 2023–2024 RSV season, CDC recommends prioritizing available nirsevimab 100mg doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease. Recommendations for using 50mg doses remain unchanged at this time. Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds) to preserve supply of 50mg doses for infants weighing <5 kilograms (<11 pounds). Providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant.

CDC further recommends that providers suspend using nirsevimab in palivizumab-eligible children aged 8–19 months for the 2023–2024 RSV season. These children should receive palivizumab per American Academy of Pediatrics (AAP) recommendations. Nirsevimab should continue to be offered to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for escalation of medical care is more challenging or in communities with known high rates of RSV among older infants and toddlers. Prenatal care providers should discuss potential nirsevimab supply concerns when counseling pregnant people about RSVpreF vaccine (Abrysvo, Pfizer) as maternal vaccination is effective and will reduce the number of infants requiring nirsevimab during the RSV season.

This week, learn how you can help your patients of any age cope with vaccination anxiety in our 4-minute video, Addressing Vaccination Anxiety: Strategies for Healthcare Professionals, from Immunize.org’s new Improving the Vaccination Experience Video Series. It is available on our YouTube channel, along with our full collection of quick video answers to popular Ask the Experts questions.

This week's featured video highlights four new 1-page resources for healthcare professionals:

Immunize.org’s series of short videos introduces you to different ways to improve the vaccination experience for infants, children, teens, and adults. Three are for a general audience, and three are intended for healthcare professionals. As with all Immunize.org resources, these videos are free to download, link, copy, and share.

CDC’s Weekly U.S. Influenza Surveillance Report, FluView, provides a valuable snapshot of influenza activity state-by-state.

Influenza Surveillance
For week 42, ending October 21, CDC’s Weekly U.S. Influenza Surveillance Report, FluView shows that, nationwide, 2.5% of patient visits reported through the Outpatient Influenza-Like Illness Surveillance Network (ILINet) were due to respiratory illness that included fever plus a cough or sore throat (i.e., influenza-like illness [ILI]). The national baseline is 2.5%. No influenza-associated pediatric deaths that occurred during the 2023–2024 season were reported this week.

RESP-NET
Visit the CDC Respiratory Virus Hospitalization Surveillance Network (RESP-NET) for weekly reports of hospitalizations across the United States due to three vaccine-preventable seasonal respiratory viruses: COVID-19, influenza, and RSV.

These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.

For the first time, Immunize.org created and posted a Spanish translation of its helpful and popular document for families, titled Tips for Locating Old Immunization Records.

Related Links

Immunize.org posted two new VISs, published by CDC.

The new COVID-19 mRNA VIS may be used when vaccinating people age 12 years and older who will receive one of the licensed mRNA vaccines (Comirnaty by Pfizer-BioNTech or Spikevax by Moderna). Because adverse events caused by COVID-19 vaccines are not covered by the Vaccine Injury Compensation Program at this time, use of the VIS is recommended, not required. COVID-19 vaccines remain covered under the Countermeasures Injury Compensation Program (CICP).

Healthcare providers continue to be required to provide the product-specific Emergency Use Authorization (EUA) Fact Sheet when administering a COVID-19 vaccine under EUA conditions. EUA Fact Sheets are required when vaccinating children age 6 months through 11 years and before giving Novavax COVID-19 Vaccine (2023–2024 Formula) to any eligible recipient. Current EUA Fact Sheets are listed on Immunize.org’s popular Checklist of Current Versions of U.S. COVID-19 Guidance and Clinic Support Tools.

The RSV VIS, originally issued in July 2023 for vaccination of adults age 60 and older, was updated with information about the September 2023 ACIP recommendation for RSV vaccination of pregnant people from 32 weeks through 36 weeks and 6 days of gestation. A separate immunization information statement (IIS) was recently posted by CDC for use with the RSV preventive antibody (nirsevimab) recommended for infants.

As with other VISs, translations will be posted on Immunize.org as they become available from our translation service or from partners who generously donate translations to our repository.

Immunize.org's www.Give2MenACWY.org website promotes the importance of adolescent vaccination, including the recommended MenACWY vaccine booster dose at age 16. Many teens are behind on vaccines because of the pandemic, so vaccine outreach is more important than ever.

Materials on this colorful website for healthcare professionals incorporate the 2020 ACIP meningococcal vaccine recommendations and coverage statistics from CDC’s National Immunization Survey–Teen (NIS–Teen). One particularly popular resource on the site is the update Algorithm for MenACWY Immunization in Adolescents 11 through 18 Years of Age.

The site also categorizes materials according to whether they are primarily of interest to providers, to adolescents, or to parents.

Visit Give2MenACWY.org and enjoy browsing (and deploying) its bountiful resources.

Related Links

CDC published Routine Vaccination Coverage—Worldwide, 2022 on October 27 in MMWR. A summary appears below.

The COVID-19 pandemic negatively affected global childhood immunization programs, resulting in lower childhood vaccination coverage. . . .

From 2021 to 2022, global coverage with the first dose of diphtheria-tetanus-pertussis–containing vaccine increased from 86% to 89%, and with the first dose of measles-containing vaccine from 81% to 84%, but neither returned to 2019 prepandemic coverage levels of 90% and 86%, respectively. Coverage recovery was unevenly distributed across regions and countries and slower among low-income countries. . . .

Strategies to provide catch-up vaccination throughout childhood have the potential to address heightened risks for vaccine-preventable disease outbreaks resulting from years of low vaccination coverage.

Access the MMWR article in HTML or PDF.

Related Link

Immunize Colorado will host a webinar titled What’s New with the Flu? + A Discussion and Updates on RSV at 1:00 p.m. (ET) on November 9. During the webinar, Suchitra Rao, MD, will discuss the data behind the 2023–24 influenza season and updates to the flu vaccine. There will also be a discussion on RSV treatments and implications for this respiratory virus season.

Register for the webinar.

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