The Advisory Committee on Immunization Practices (ACIP) met on September 22, 2023, to review Abrysvo, Pfizer’s respiratory syncytial virus (RSV) vaccine (“RSVpreF"). Because only one of two RSV vaccines is licensed and recommended for use during pregnancy, this summary will refer to it by its brand name. Abrysvo is licensed for use during pregnancy from 32 through 36 weeks gestation to prevent lower respiratory tract disease (LRTD) in infants. ACIP voted 11—1 to recommend seasonal (generally, September through January) use of the vaccine. All infants younger than 8 months are now recommended to receive either nirsevimab (monoclonal antibody) before or during their first RSV season or to be protected through RSV vaccination of their mother during pregnancy. In rare cases, both forms of protection may be appropriate. Presentation slides from the meeting are available online. Immunize​.org describes the meeting’s highlights below. Following the meeting, the CDC director officially accepted the recommendations.
 
Separately, CDC announced that it will issue updated U.S. Recommended Immunization Schedules for adults and for children and adolescents, publishing an addendum to each schedule in the first week of October 2023. These schedules will incorporate updated ACIP recommendations since CDC published the 2023 schedules in February. Publishing the updated official schedules will reduce the time required to initiate insurance coverage of newly recommended immunizations, and help clinicians implement new recommendations. Updated schedules will have changes highlighted in red and include an additional page that summarizes new recommendations for COVID-19, RSV, poliovirus, and influenza published since February.
 
RSV background
RSV is a highly contagious virus that causes respiratory infections in people of all ages. RSV is the leading cause of hospitalization of infants in the United States; 2–3% of young infants are hospitalized with RSV, resulting in 58,000 to 80,000 hospitalizations and 100 to 300 childhood deaths per year. RSV circulation in the United States is seasonal, typically starting in the fall and peaking in the winter, although seasonality was temporarily disrupted during the COVID-19 pandemic.
 
The September 22 meeting focused on preventing RSV illness in early infancy through vaccination with the Abrysvo brand of RSV vaccine during pregnancy. The Arexvy (GSK) brand of adjuvanted RSVpreF vaccine is not licensed for use during pregnancy and was not discussed. This is the third set of RSV prevention recommendations made by ACIP in recent weeks. Earlier recommendations include:

• Abrysvo (Pfizer) and Arexvy (GSK) vaccines for adults 60 years and older with shared clinical decision-making (SCDM), and
• Nirsevimab (Beyfortus, AstraZeneca/Sanofi), a long-acting monoclonal antibody, to prevent RSV disease in all infants younger than 8 months and certain high-risk children age 8 through 19 months.

Abrysvo given during pregnancy at least 14 days before delivery was shown in clinical trials to reduce the risk of a medical visit due to RSV LRTD by about half in the first 6 months of life and to reduce the risk of severe LRTD by about 70%.
 
Vaccine safety and coadministration during pregnancy
Abrysvo is licensed only for use during pregnancy between 32 and 36 weeks gestation. Clinical trials demonstrated possible associations between RSVpreF and prematurity and hypertension during pregnancy. However, the number of cases were too few to know whether the vaccine caused these issues or they occurred by chance. By limiting vaccination to no earlier than a gestational age of 32 weeks, any risk of premature delivery is minimized. Vaccine safety monitoring (including updated v-safe voluntary smartphone monitoring, adapted from the COVID-19 v-safe system) will enhance safety surveillance as widespread use of the vaccine begins.
 
When Abrysvo and Tdap were administered at the same time, studies found a decreased immune response to pertussis. The clinical significance of this finding is not known. Additional experience will be needed to decide if this is a meaningful issue. Since Tdap is recommended during pregnancy beginning at 27 weeks gestation, this interaction can be avoided by giving Tdap and Abrysvo at different prenatal visits.
 
Cost effectiveness
Although it is safe to administer RSV vaccine to a mother and then nirsevimab to the infant, the use of both products for the same infant increased costs without providing much additional benefit over choosing either timely vaccination or administration of monoclonal antibody. Because protection from maternal vaccination wanes over 6 months from birth, economic analysis showed that the most valuable strategy would be to restrict maternal RSVpreF vaccination to specific months of the year when infants would benefit from immediate protection during RSV season. For infants born outside RSV season (e.g., April through September), administration of nirsevimab immediately before the RSV season is the most effective and practical option for RSV protection.
 
Vote
ACIP voted 11-1 to adopt the following recommendation: “Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants.” One member opposed the motion due to its complexity and preferred a simpler recommendation.
 
Seasonal timing of vaccination
ACIP recommended that Abrysvo be administered during pregnancy, in general, only from September through January to protect infants born during the RSV season. In jurisdictions where timing of the RSV season may differ (e.g., Alaska, Hawaii, Puerto Rico, U.S. Virgin Islands, Guam, parts of Florida), ACIP recommends flexibility and that timing of vaccination be directed by public health officials based on local conditions.
 
Use of either Abrysvo during pregnancy or nirsevimab after delivery
Pregnant people should be counseled about both options and be able to choose whether to be vaccinated during pregnancy (if the timing is appropriate) or to have the infant receive nirsevimab after delivery. ACIP expresses no preference during months where vaccination during pregnancy is an option (e.g., September through January). Because both products are new in fall 2023, it will take some time before there is widespread availability of both options.

Mothers and healthcare providers must weigh several considerations:

• Maternal RSV vaccination at least 14 days before birth results in protection immediately at birth, which wanes over the next 6 months; however, protection is not optimal if the infant is born sooner than 14 days after vaccination or if the mother’s immune system fails to produce sufficient antibodies.
• Nirsevimab lasts longer, provides direct protection as soon as administered to the baby, and has no effect on the pregnancy. However, if the infant’s healthcare provider does not yet stock nirsevimab, the family could have difficulty accessing the product.

Mothers who should receive RSV vaccination meet all three of these criteria:

1. The time of year is between September and the end of January (unless public health authorities recommend different timing based on local RSV circulation), and
2. The mother is between 32 and 36 weeks gestation, and
3. The mother does not prefer to have the infant receive nirsevimab (or the infant will not have access to nirsevimab)

In the context of the maternal vaccination option, infants younger than 8 months who need nirsevimab should meet all three of these criteria:

1. The time of year is between October and March, and
2. The infant’s mother did not receive RSVpreF vaccine, or the vaccination status cannot be confirmed, or the mother received RSVpreF vaccine sooner than 14 days before delivery, and
3. The infant has not previously received nirsevimab

Consistent with these criteria, nirsevimab is indicated for all infants born before 34 weeks gestational age (because Abrysvo cannot be given earlier than 32 weeks) and for all infants born in April through September (whose mothers will not be offered vaccine).
 
In rare situations, nirsevimab should be given to certain infants born 2 weeks or more after maternal vaccination. Examples include:

• Conditions in pregnant people resulting in an inadequate immune response to vaccine or decrease in transplacental antibody transfer (e.g., people living with HIV infection)
• Infants who have undergone cardiopulmonary bypass, leading to loss of maternal antibodies
• Infants at high risk for severe RSV disease (e.g., hemodynamically significant congenital heart disease, intensive care admission and requiring oxygen at discharge)

Additional clinical considerations

• Simultaneous vaccinations: it is acceptable to give Abrysvo at the same visit with other vaccinations
• Subsequent pregnancies: ACIP currently recommends only one dose of RSV vaccine during a single pregnancy. ACIP will consider whether to recommend RSV vaccination during subsequent pregnancies as more data become available

Implementation

• Communication challenges: ACIP members noted that the success of this complex recommendation requires effective documentation and communication between obstetric teams and pediatric teams about the mother’s RSV vaccination status or need for nirsevimab. It is not possible to document maternal vaccination on an infant’s record in state immunization information systems (IIS). Some state privacy laws may prevent a pediatrician from reviewing the mother’s vaccination record in an IIS (because the mother is not their patient). In cases where the mother’s vaccination status cannot be confirmed by the pediatric care provider, nirsevimab should be administered if otherwise indicated.
• Supply: Abrysvo for mothers is the same vaccine used for adults age 60 years or older, so it is already commercially available. Nirsevimab will begin shipping in early October, but may not be available in all pediatric settings this season.

Future ACIP meetings
The next scheduled ACIP meeting will be held on October 25–27, although additional emergency meetings may be announced before that time. Information about past and future ACIP meetings appear at the ACIP website.  
 
Related Links

• ACIP main page for content from previous meetings, as well as information about future meetings
• CDC: ACIP Presentation Slides: September 22, 2023, Meeting web page
• FDA: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

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Immunize​.org posted 28 new translations of the Vaccine Information Statement (VIS) for respiratory syncytial virus (RSV) vaccination of adults age 60 years or older using shared clinical decision-making.  These translations join the Spanish (RTF) VIS. 

All translations are available in print-ready PDF format.



Respiratory Syncytial Virus (RSV) Vaccine VIS: (view in English):

Related Links

• Immunize​.org: Respiratory Syncytial Virus (RSV) VIS main page
• Immunize​.org: Respiratory Syncytial Virus (RSV) Vaccine VIS (PDF, English)
• Immunize​.org: Vaccine Information Statements main page with VISs in up to 47 languages
• CDC: What's New with VISs main page
• CDC: Current VISs main page

The Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP) recently released new education modules to support adult and pediatric providers, immunization champions, caregivers and community members. These free online modules were developed and supported by the Vaccine Education Center and multiple city, state, and national partners. These web-based interactive sessions offer training in the following topics: 

Trusted Messenger Engagement to Dispel Misinformation and Promote Vaccine Confidence for All Vaccines 

• Part 1: As the COVID-19 Public Health Emergency Ends, What Happens Next? 
• Part 2: Identifying Vaccine Misinformation and Stopping It 
• Part 3: Having Evidence-Based Empathetic Vaccine Conversations: Tackling Common Misconceptions 

Vaccine Education and Autism: Supporting Provider and Community Needs 

• Module 1 (for Providers): Vaccine Equity for Autistic People and Communicating About Vaccines 
• Module 2 (for Providers): Optimizing the Vaccination Experience for Neurodiverse People 
• Module A (for Caregivers): The Importance of Vaccines 
• Module B (for Caregivers): Optimizing the Vaccination Experience for Neurodiverse People 

To learn more about the modules, visit chop.edu/vaccine-online-learning. Each of the modules, except for the two designed for caregivers (Modules A-B), offer options to receive continuing education credit. 



Related Links

• CHOP: Online Learning for Healthcare Providers web page 
• CHOP: Vaccine Update for Healthcare Professionals web page

Immunize​.org’s Standing Orders Templates for Administering Vaccines main page includes 42 straightforward standing order templates that allow qualified healthcare professionals to assess the need for and administer vaccines to patients meeting certain criteria, such as age or underlying medical condition. In addition to templates developed by Immunize​.org, the page includes links to CDC’s standing orders templates for all COVID-19 vaccines and all age groups, as well as CDC's standing orders template for mpox vaccination with Jynneos (Bavarian Nordic).

In response to recent ACIP recommendations, Immunize​.org received numerous inquiries about the status of an updated standing order template for COVID-19 vaccines as well as RSV vaccine for older adults. 

• Since 2021, CDC has developed COVID-19 vaccine standing order templates. Immunize​.org alerts our readers and posts these templates on our website alongside our other standing order templates.
• Regarding RSV vaccine for older adults, there is not a standing order template because the vaccine is recommended through shared clinical decision-making (SCDM) requiring a clinical assessment and discussion of each patient’s health status, risks, risk tolerance, and potential benefits of vaccine. The need for this type of clinical assessment and SCDM does not lend itself to a single template of the type developed by Immunize​.org, which works best for vaccines with routine recommendations.

Standing orders help you increase vaccination rates by enabling assessment and vaccination of the patient without the need for clinician examination or a direct order from the attending provider at the time of the interaction. Standing orders can be established for the administration of one or more specific vaccines to a broad or narrow set of patients in healthcare settings such as clinics, hospitals, pharmacies, and long-term care facilities.

Visit the Standing Orders Templates for Administering Vaccines main page on Immunize​.org to view the standing orders templates.

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Immunize​.org's Influenza Vaccination Honor Roll recognizes facilities that take a stand for patient safety by implementing policies requiring healthcare personnel influenza vaccination. There are now 1,334 organizations enrolled. Immunize​.org recently welcomed two additional healthcare organizations.

• Pedicorp, PC, West Hartford, CT
• Kittitas Valley Healthcare, Ellensburg, WA

Eligibility:

• Eligible organizations: Hospitals, long-term care facilities, medical practices, pharmacies, professional organizations, health departments, and other government entities
• Requirements:
  • Your policy must require influenza vaccination for all staff
  • The application must describe measures to prevent transmission of influenza from unvaccinated personnel to patients (e.g., masking for the entire work shift)

• Immunize​.org: list of Influenza Vaccination Honorees, all healthcare settings, by state
• Immunize​.org: Long-Term Care/Assisted Living Influenza Vaccination Honorees by state
• Immunize​.org: Influenza Vaccination Honor Roll program, including:
  • Position statements from professional societies and leading healthcare organizations in support of mandatory influenza vaccination
  • Application form for Influenza Vaccination Honor Roll
• Immunize​.org: Honor Roll for Patient Safety web page

Journalists seek out Immunize​.org experts to help explain vaccines to the public and policy makers. We help the media understand and communicate the complex work vaccinators do. Here is a recent citation.

• Washington Post: Americans Trying to Get New COVID Vaccine Hit Insurance Snags, Face Bills (9/22/23)

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

• HHS: Letter from HHS Secretary on COVID-19 Vaccine Coverage (9/22/23)
• The Hill: New COVID Vaccine Campaign Off to a Bumpy Start (9/21/23)
• CNN: Supply and Insurance Issues Snarl Fall COVID-19 Vaccine Campaign for Some (9/20/23)
• USA Today: No, CDC Data Doesn’t Show 99% of Reported COVID-19 Deaths Were From Other Causes: Fact Check (9/18/23)
• STAT: Polio Transmission Was Supposed to End by 2023. A New Report Explains Why It Won’t (9/15/23)

Immunize​.org recently updated its resource for healthcare professionals titled Before You Vaccinate Adults, Consider Their “H-A-L-O”!

H-A-L-O refers to four factors:

• Health condition
• Age
• Lifestyle
• Occupation

Changes were made to add RSV vaccine for adults age 60+ based on shared clinical decision-making.

Related Links

• Immunize​.org: Clinic Tools: Vaccine Recommendations web page
• Immunize​.org: Handouts: Vaccine Recommendations web page

Immunize​.org recently updated its resource for healthcare professionals titled Vaccine Administration Record for Children and Teens. Edits incorporate additional vaccines (DTaP-IPV-Hib-HepB, PCV15, PCV20, COVID-19, dengue, Priorix) and long-acting RSV monoclonal antibody (nirsevimab), and also indicate that M-M-R II, Varivax, and ProQuad from Merck may be given intramuscularly or subcutaneously.

• Immunize​.org: Handouts for Patients and Staff main page, where you can view materials by topic, vaccine, or language
• Immunize​.org: Educational Materials for Patients and Staff—an alphabetical listing of more than 240 ready-to-print staff educational materials and patient handouts

Immunize​.org posted 12 translations of the multi-vaccine Vaccine Information Statement (VIS) titled Your Child’s First Vaccines VIS, which CDC updated on July 24, 2023. These translations join the Spanish (RTF) VIS. This VIS provides information on diphtheria, tetanus, pertussis, Hib, hepatitis B, pneumococcal, and poliovirus vaccines, including 20-valent pneumococcal conjugate vaccine (PCV20) as an option for vaccination.

All translations are available in print-ready PDF format.
 


Your Child’s First Vaccines (view in English):

• Arabic 
• Burmese 
• Chinese–Simplified 
• Chinese–Traditional 
• Farsi
• French 
• Haitian Creole
• Portuguese
• Russian
• Somali
• Tagalog
• Vietnamese

Check the version dates of your office copies of newly updated translations. Translations of previous VIS versions should be discarded now that translations of the current version are available.

Related Links

• Immunize​.org: Multi-vaccine VIS main page
• Immunize​.org: Vaccine Information Statements main page with VISs in up to 47 languages
• CDC: What's New with VISs main page
• CDC: Current VISs main page

The American Academy of Family Physicians (AAFP) published two articles on universal hepatitis B vaccination recommendations in a supplement to the September/October edition of Family Practice Management.

• Understanding the Updated Hepatitis B Vaccination Recommendations and Guidance 
• Implementing and Understanding Barriers to the Updated Hepatitis B Vaccination Recommendations and Guidance

The articles explain the CDC recommendations for hepatitis B vaccination, the vaccines available in the United States, and the hepatitis B vaccination schedule for adults. 

• AAFP: Understanding the Updated Hepatitis B Vaccination Recommendations and Guidance (PDF)
• Family Practice Management: Understanding the Updated Hepatitis B Vaccination Recommendations and Guidance 

CDC published Progress toward Poliomyelitis Eradication—Afghanistan, January 2022–June 2023 in the September 22 issue of MMWR. A portion of the abstract appears below.

Wild poliovirus type 1 (WPV1) remains endemic only in Afghanistan and Pakistan. . . .

Afghanistan reported two WPV1 cases during 2022 and five during 2023 through June 30. All cases were detected along the Pakistan border, and all patients during 2023 had a history of receipt of ≥16 oral poliovirus vaccine doses. During May 2023, WPV1 circulation was detected for the first time in >2 years in the south region of Afghanistan, where restrictions prohibiting house-to-house vaccination limit the effectiveness of immunization campaigns. . . .

Interruption of WPV1 transmission in Afghanistan is attainable and requires regular and unrestricted supplementary immunization activities (mass campaigns), improved surveillance, and strong coordination of vaccination activities with neighboring Pakistan.

Access the MMWR article in HTML and PDF. 



Related Link

• MMWR’s main page provides access to the MMWR family of publications

CDC published Circulating Vaccine-Derived Poliovirus Type 2 Emergences Linked to Novel Oral Poliovirus Vaccine Type 2 Use—Six African Countries, 2021–2023 in the September 22 issue of MMWR. The first paragraph appears below.

Circulating vaccine-derived poliovirus (cVDPV) outbreaks can occur when oral poliovirus vaccine strains (most often, Sabin monovalent oral poliovirus vaccine type 2 [mOPV2]) undergo prolonged circulation in undervaccinated populations, resulting in genetic reversion to neurovirulence. A novel type 2 oral poliovirus vaccine (nOPV2) has been developed, which has been shown in clinical trials to be less likely than mOPV2 to revert to paralytic variants and to have limited genetic modifications in initial field use. Approximately 700 million doses of nOPV2 have been administered worldwide in response to outbreaks of cVDPV type 2 (cVDPV2). cVDPV2 detections originating from nOPV2 use from initial rollout during March 2021–September 7, 2023, are described in this report.

Access the MMWR article in HTML and PDF. 



Related Link

• MMWR’s main page provides access to the MMWR family of publications

Children's Hospital of Philadelphia (CHOP) will host a virtual webinar titled Considering the Role of Preparation in Science - 2023 Maurice R. Hilleman Essay Contest Virtual Event on September 29 from 3:00 to 5:00 p.m. (ET). This event will celebrate the legacy of prolific vaccine developer Dr. Maurice Hilleman and honor the young winners of the 2023 Maurice R. Hilleman Essay Contest. The winners will each receive $500, a certificate, and recognition during this event.

Register for the Considering the Role of Preparation in Science - 2023 Maurice R. Hilleman Essay Contest Virtual Event.