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Immunize.org summarizes ACIP’s August 3 meeting recommending nirsevimab for RSV prevention in infants and inclusion in Vaccines for Children program
The Advisory Committee on Immunization Practices (ACIP) met on August 3 and recommended routine use of the monoclonal antibody product nirsevimab (trade name: Beyfortus, Sanofi) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants younger than age 8 months during their first RSV season and in some children at high risk of severe disease during their second RSV season. Nirsevimab received FDA approval on July 17. Presentation slides are available online. Immediately after the meeting, CDC issued a media release announcing the director had adopted the ACIP recommendations, a step that initiates processes related to insurance coverage and implementation. Highlights of the meeting are provided below.
RSV Epidemiology
RSV is a common cause of respiratory illness and the leading cause of hospitalization of infants in the United States. Most (68%) infants are infected in the first year of life, and nearly all (97%) are infected by age 2 years. Of those infants with RSV infection, 2–3% require hospitalization, with an estimated 58,000–80,000 U.S. children younger than age 5 years hospitalized annually.
RSV infection typically causes mild upper respiratory symptoms, but can also cause bronchiolitis and pneumonia. Severe disease is most likely in very young infants and older infants born prematurely or with serious chronic diseases. Rates of severe disease are also 4–10 times greater in American Indian/Alaska Native (AI/AN) children than in the general population. Approximately 100–300 children younger than age 5 years die from RSV each year.
The RSV season typically occurs during October through March. The timing and severity of the season varies from year to year and between locations, particularly in areas outside the contiguous United States, such as Alaska, Hawaii, and overseas U.S. territories.
Nirsevimab Use
Nirsevimab is a long-acting monoclonal antibody product that provides passive immunization to the recipient for at least 150 days after administration. The pre-formed antibodies do not stimulate the immune system like an active immunization (vaccine). The rate of RSV-associated hospitalizations among recipients in clinical trials was 83% lower than among placebo recipients, and the rate of severe disease was 76% lower. Side effects were rare, with injection site reactions and rash reported in fewer than 1% of recipients.
Nirsevimab is administered intramuscularly (IM), with three dosing options based upon the child’s age and weight. Timing of nirsevimab administration is seasonal. Infants born during (or shortly before) the RSV season should be immunized within the first week of life (either before discharge from the delivery hospital or as an outpatient). Infants younger than 8 months of age who are born outside the season should receive nirsevimab shortly before, or early in, their first RSV season, and may be immunized when receiving other routine live or non-live vaccinations. Infants weighing less than 5 kg receive a 50 mg dose, and those weighing 5 or more kilograms receive a 100 mg dose.
ACIP separately recommended a 200 mg dose of nirsevimab (given as two 100 mg injections) for children age 8 through 19 months entering their second RSV season and at high risk of severe disease. Those recommended to receive nirsevimab in their second RSV season include those currently recommended by the American Academy of Pediatrics to receive palivizumab, a different monoclonal antibody that requires monthly administration. In addition, immunization was recommended for AI/AN children, who, as a population, are at high risk of hospitalization with RSV.
Nirsevimab is supplied in pre-filled 50 mg and 100 mg syringes that are stored at 2o–8oC, like refrigerated vaccines. The retail cost will be $495 per dose for 50 mg or 100 mg prefilled syringes. CDC will publish additional clinical considerations and professional educational materials in coming weeks.
Unique Implementation Considerations
The ACIP decision to include nirsevimab in the Vaccines for Children (VFC) program will facilitate access for all infants, regardless of insurance status. However, some implementation challenges remain because the product is not a traditional vaccine. Some jurisdictions may have different scope of practice regulations related to who is allowed to administer it. Seasonal administration will require planning and training. Payment issues will need to be addressed to facilitate its use in birthing hospitals. There may be issues to resolve in electronic health record system documentation and reporting to state immunization information systems.
ACIP Vote
ACIP made two separate and unanimous votes to recommend nirsevimab for two groups:
- Infants younger than age 8 months born during or entering their first RSV season should receive one dose (50 mg for infants weighing less than 5 kg, 100 mg for those 5 kg or more)
- Children age 8 months through 19 months who are at increased risk of severe RSV disease and entering their second RSV season – one dose (200 mg)
The Committee also unanimously approved including nirsevimab in the VFC program.
Future discussions
ACIP members noted that a maternal vaccination for RSV designed to protect newborns is being considered for licensure by FDA. If a maternal RSV vaccine is licensed and recommended, ACIP will revisit the nirsevimab recommendations and adjust them as necessary.
The next scheduled ACIP meeting will be held on October 25–27, 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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New! Immunize.org updates its summaries of 2023 state immunization requirements for childcare, school, and college entry, including new summary maps. Childcare and school requirements for vaccination vary by state and are critical to making childcare facilities and schools a safe and healthy learning environment for everyone. In the spring of 2023, Immunize.org surveyed all state immunization program managers to update its detailed data tables on state vaccine-specific requirements for childcare, school, and college students. Based on information provided or confirmed by immunization managers, Immunize.org updated its State Requirements by Vaccine main page and each of its pages detailing vaccine-specific requirements by state for childcare, K-12, and post-secondary education settings. In addition, new and improved state maps were produced to visually represent vaccine-specific requirements and state policies related to exemptions. These maps are ideal for use in presentations by policymakers, healthcare professionals, and advocates.
Below are links to each of the vaccine-specific requirement pages and the exemptions page:
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August is National Immunization Awareness Month; promote vaccination with helpful resources for all ages
August is National Immunization Awareness Month (NIAM). This annual observance highlights the efforts to protect people of all ages against vaccine-preventable diseases through on-time vaccination. This year, NIAM serves as a focal point to get back on track with routine vaccines.
NIAM is a good time to remind healthcare providers that they are still the most trusted source of vaccine information for parents and patients. Encourage patients to schedule appointments to ensure they are up to date on annual exams and recommended vaccines.
CDC’s NIAM web page includes two toolkits, one for reaching healthcare professionals and the other for reaching parents and patients. Each includes key messages, sample social media content, and educational resources. CDC encourages its partners to share these messages and resources throughout August using the hashtag #ivax2protect.
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Review your COVID-19 resources with new version of Immunize.org’s “Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools” Immunize.org reviews and updates the Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools at least monthly, prominently indicating when it was last revised at the top of the page. Changes on the August 1 update include weblinks to new versions of:
- COVID-19 ACIP recommendations
- Pfizer-BioNTech Emergency Use Authorization (EUA) for Healthcare Providers
- COVID-19 Vaccination Recommendations infographics (2 versions: for people with or without immunocompromise)
- “At-A-Glance” summaries for Pfizer-BioNTech and Moderna COVID-19 vaccines
- Vaccine Storage and Handling Guidance websites (CDC is no longer publishing individual vaccine storage and handling PDFs)
All COVID-19 vaccination providers should review the checklist regularly and download the latest CDC schedule and standing order documents. The checklist is posted on Immunize.org's Vaccines: COVID-19 main page to help practices stay up to date.
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“Meningococcal ACWY Vaccine Schedule”: watch the 2-minute answer, part of the Ask the Experts Video Series on Facebook, LinkedIn, Twitter, YouTube, and Instagram
Immunize.org’s social media program highlights our educational resources for today’s vaccinators. This week, our featured episode from the Ask the Experts Video Series is Meningococcal ACWY Vaccine Schedule. This is available on our YouTube channel, along with our full collection of quick video answers to popular Ask the Experts questions.
Our social media channels feature our most popular printable resources, our Ask the Experts Video Series, and announcements important to frontline vaccinators. Like, follow, and share Immunize.org’s social media accounts. Encourage colleagues and others interested in vaccination to do likewise:
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Pages and Handouts
Immunize.org updates its “Ask the Experts” web page on polio vaccine Immunize.org's popular Ask the Experts: Polio web page was updated to reflect new ACIP recommendations for adult vaccinations in June 2023. ACIP now recommends that all U.S. adults who are known or reasonably suspected of being unvaccinated or incompletely vaccinated against polio should receive a primary series of polio vaccine. Take this opportunity to refresh your polio vaccine knowledge by reviewing the questions and answers.
Immunize.org’s Ask the Experts main page leads you to 30 web pages on various topics with more than 1,200 common or challenging questions and answers about vaccines and their administration. Immunize.org’s team of experts includes Kelly L. Moore, MD, MPH (team lead), Carolyn B. Bridges, MD, FACP, and Iyabode Beysolow, MD, MPH.
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Recap: Immunize.org updated these clinic resources in June and July
IZ Express regularly summarizes Immunize.org’s new and updated educational materials and web pages. All Immunize.org materials are free to distribute. In recent weeks, Immunize.org updated these helpful materials:
Immunize.org Materials for Clinicians
Immunize.org Printable Materials for Patients
Immunize.org Web Pages
Related Links
- Immunize.org: Handouts main page to see educational materials sorted by category
- Immunize.org: Ask the Experts main page to access more than 1,200 questions answered by Immunize.org experts
- Immunize.org: Clinic Tools main page and its eight subtopics
- Immunize.org: Educational Materials for Patients and Staff—an alphabetical list of more than 240 ready-to-print staff educational materials and patient handouts
Vaccine Information Statements
Recap: Vaccine Information Statements and translations released in June and July
IZ Express regularly provides readers with information about new and updated Vaccine Information Statements (VISs) and their translations.
On July 24, CDC released an updated interim VIS for Multi Pediatric Vaccines (Your Child's First Vaccines) and a new VIS for Respiratory Syncytial Virus (RSV) Vaccine for adults.
As a result of these VIS releases, two handouts related to VISs were updated:
On May 12, CDC released interim VISs for Hepatitis B Vaccine and Pneumococcal Conjugate (PCV) Vaccine, and Immunize.org provided eight translations for each.
Hepatitis B Vaccine (view in English):
Pneumococcal Conjugate Vaccine (view in English):
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Featured Resources
ACOG shares educational resources on maternal immunization for NIAM For National Immunization Awareness Month (NIAM), the American College of Obstetricians and Gynecologists (ACOG) is highlighting the importance of maternal immunization with a searchable list of educational resources.
They offer:
These resources can be effective tools for sharing accessible, evidence-based information on COVID-19, Tdap, and influenza vaccination during pregnancy. The suite also includes information on HPV, mpox, and other adult vaccines. Please share these resources with your networks.
View ACOG's resources.
ACOG offers training course, “Inform to Empower: Building COVID-19 Vaccine Confidence One Conversation at a Time,” for physicians and other obstetric care clinicians; CME offered
Notable Publications
“Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021” published by CDC
On July 19, CDC published Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021. The conclusion section appears below.
Coverage increased for influenza and herpes zoster vaccination in recent years. Disparities in vaccination coverage by race and ethnicity were seen for all vaccines assessed. Increasing the proportion of adults who receive recommended vaccines and ensuring equitable access to, and uptake of recommended vaccines is a high-priority public health issue.
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“Measles Outbreak—Central Ohio, 2022–2023” published in MMWRCDC published Measles Outbreak—Central Ohio, 2022–2023 on August 4 in MMWR. Our analysis of Notes from the Field is summarized below.
- Although the United States has maintained measles elimination since 2000, measles outbreaks continue to occur in countries around the world. Thus, there is always a risk of measles importation that could affect undervaccinated communities.
- In November 2022, two 2-year-old children were admitted to the same hospital in Ohio for suspected measles infection, so public health officials launched an investigation
- A total of 85 people in central Ohio tested positive for measles
- This outbreak was characterized by young median patient age (1 year), low rates of MMR vaccination, and high rates of respiratory coinfection (e.g., respiratory syncytial virus [RSV]), with twice the hospitalization rate reported among previous U.S. measles cases
- Two-dose MMR vaccination coverage among children entering kindergarten in Ohio during the 2021–22 school year (i.e., before the outbreak) was 5% lower than the national coverage estimate of 93%
- Healthcare facilities, clinicians, and childcare centers serving undervaccinated populations should remain on high alert for measles and emphasize the importance of timely MMR vaccination
Access the MMWR article in HTML or PDF.
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“Safety Monitoring of Novavax COVID-19 Vaccine among Persons Aged ≥12 Years—United States, July 13, 2022–March 13, 2023” published in MMWR
CDC published Safety Monitoring of Novavax COVID-19 Vaccine among Persons Aged ≥12 Years—United States, July 13, 2022–March 13, 2023 on August 4 in MMWR. Our analysis of Notes from the Field is summarized below.
- Novavax COVID-19 vaccine is authorized and recommended as
- A primary 2-dose monovalent vaccination series in people age 12 and older
- A monovalent booster dose in people age 18 and older who are unable or unwilling to receive an mRNA COVID-19 bivalent vaccine
- To assess the safety of the Novavax COVID-19 vaccine among individuals age 12 years and older, CDC reviewed reports made to the Vaccine Adverse Event Reporting System (VAERS) from July 13, 2022, to March 13, 2023
- No unexpected safety concerns were identified. The most commonly reported adverse events were nonserious and included reports of dizziness, fatigue, and headache.
- This review underscores the safety of the Novavax COVID-19 vaccine
- It’s important to stay up to date with COVID-19 vaccines to prevent severe illness
Access the MMWR article in HTML or PDF.
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Global News
WHO releases message from Director of Immunization, Vaccines, and Biologicals on the release of country vaccination estimates On July 31, the World Health Organization (WHO) released Message by the Director of the Department of Immunization, Vaccines and Biologicals at WHO—July 2023. A portion of the article appears below.
The WHO/UNICEF estimates of national immunization coverage (WUENIC) for 2022 were released on 18 July. . . .
The WUENIC findings are encouraging: some immunization services have begun to recover after the disruptions caused by COVID-19 – meaning that immunization services reached 4 million more children than in 2021. Despite this overall improvement, the recovery has been uneven across countries, across vaccines, and across age groups. Even with evidence of a recovery underway in 2022, more than 20 million children still missed out on one or more vaccines last year, and over 14 million missed out entirely. These numbers are higher than in 2019, the year before the pandemic hit. . . .
Most concerningly is that as a group, low-income countries are not yet showing signs of immunization recovery. For these countries, measles vaccine coverage has continued to backslide in 2022, raising the alarm even further for immediate action. We must catch-up, restore, and strengthen all national immunization programs to ensure that all children, no matter where they are, have access to and receive the life-saving vaccines which are their right.
The WUENIC-2022 release of country estimates coincided with the halfway mark for the Big Catch-Up, underscoring the need for sustained action to strive for catch-up, equitable recovery and strengthening for the remainder of the year and beyond.
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