Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

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Maternal RSV Vaccine Implementation 

Considerations

Georgina Peacock, MD, MPH

Immunization Services Division

Centers for Disease Control and Prevention
▪ Vaccine storage, handling, and administration

▪ Cost of vaccine

▪ Insurance coverage

▪ Supply and availability

▪ Complexity of immunization schedule

▪ Vaccine demand and coverage in pregnant people

▪ Obstetric and pediatric provider roles in vaccination decisions

▪ Immunization information systems

▪ Communication challenges

Maternal RSV Implementation Considerations
▪ Overall clinical implementation similar to other vaccines

– Stored at 2◦ to 8◦ C

– Administered as a single dose through intramuscular route

▪ Additional steps required for dilution, 

including reconstitution of the lyophilized antigen 

component with the sterile water diluent component

Pfizer RSV Vaccine Storage, Handling, and Administration

Package Insert -ABRYSVO (STN 125769/26) | FDA

▪ Proposed recommendations to ACIP allow for simultaneous administration 

with other recommended vaccines

▪ Increasing number of vaccines could lead to concerns for limited storage space

Supplied as a kit with the following components:
▪ Cost of the Pfizer RSV vaccine is $295/dose, compared to ~$46-52 for Tdap1

– Cost is lower than infant nirsevimab ($495 private sector cost)

▪ Reimbursement and cost recovery challenges already identified by providers and 

practices as an implementation barrier for maternal immunization2

Cost of Maternal RSV Vaccine

1. Current CDC Vaccine Price List | CDC

2. Immunization Practices of U.S. Obstetrician/Gynecologists for Pregnant Patients | ScienceDirect
Provider Financial Concerns 

are a Leading Barrier to 

Maternal Immunization

Immunization Practices of U.S. Obstetrician/Gynecologists for Pregnant Patients | 

ScienceDirect
▪ Private insurance: 52% of pregnant people1

– The Affordable Care Act (ACA) requires insurers to cover all ACIP-routinely recommended 

immunizations for plan years that begin on or after the date that is one year after the date of the 

recommendation2

▪ Medicaid: 41% of pregnant people1

– After 10/1/23, when the Inflation Reduction Act provisions become effective, state Medicaid agencies 

will be required to cover vaccines and their administration without cost-sharing for nearly all fullbenefit adult beneficiaries covered under traditional Medicaid, if the CDC/ACIP recommendations 

apply3

▪ No insurance: 4% of pregnant people “self-pay” (likely uninsured)1

– If recommended, ACIP will vote on a Vaccines for Children resolution for maternal RSV vaccine in 

people aged <19 years

– For people age 19+ years, limited availability (e.g., through 317 program)

Insurance Coverage of Maternal RSV Vaccine

1. Products - Data Briefs - Number 468 - May 2023 (cdc.gov); insurance status refers to source of payment for delivery. Another ~3% used other types of coverage

2. 42 U.S. Code § 300gg–13 - Coverage of preventive health services | Cornell Law School

3. Anniversary of the Inflation Reduction Act: Update on CMS Implementation | CMS
▪ ACIP has recommended nirsevimab as a routine immunization. Therefore, it will be 

covered under the ACA without cost sharing by the patient starting in the effective 

plan year1

▪ Nirsevimab is included in the Vaccines for Children Program2

– Eligible children (~50% of U.S. children) will be able to access nirsevimab at no cost

Insurance Coverage for Infant Nirsevimab

1. 42 U.S. Code § 300gg–13 - Coverage of preventive health services | Cornell Law School

2. Advisory Committee on Immunization Practices, Vaccines for Children Program | CDC
▪ No anticipated supply/demand mismatch

▪ Because the Pfizer maternal RSV vaccine is the same product in use for adults aged 

≥60 years, availability is expected shortly after ACIP recommendations

▪ Nirsevimab will likely be available late September/early October, but may not be 

available in all pediatric settings this season

– Efforts underway to increase number of birthing hospitals who will administer nirsevimab

Supply and Availability of Maternal RSV Vaccine and 

Nirsevimab During 2023–2024 RSV Season
Increasing Complexity of Maternal Immunization Schedule

▪ Increasingly complex maternal immunization schedule, with different timing of 

vaccines based on season and/or gestational age (with seasonal timing varying in 

some locations)

▪ Limited window for RSV vaccine administration

▪ Unclear willingness of pregnant people to accept multiple vaccines in pregnancy
In a survey of pregnant people, 12% said they would accept 

no vaccines, and 49% said they would accept 1-2 vaccines

CDC and University of Iowa/RAND survey, unpublished
Uptake of Vaccines among Pregnant People Has Declined 

and Disparities Persist

Flu, Tdap, and COVID-19 Vaccination Coverage Among Pregnant Women –United States, April 2022 | CDC
▪ Decisions for whether to administer maternal RSV vaccine or infant nirsevimab will 

need to be made during pregnancy

▪ Studies continue to demonstrate healthcare providers as pregnant people’s most 

trusted source of information on vaccines, and provider recommendation is a strong 

predictor of vaccination1

▪ However, one survey showed that 2/3 of obstetricians did not feel providing 

information about routine childhood immunizations was part of their role2

Obstetric Provider Role in Immunization Decisions

1. Lutz C, et al. Understanding barriers and predictors of maternal immunization: Identifying gaps through an exploratory literature review. Vaccine 36 (2018): 7445-7455

2. Missed Opportunities: A National Survey of Obstetricians About Attitudes on Maternal and Infant Immunization | SpringerLink
▪ Recommendations for nirsevimab that are contingent upon knowledge of maternal 

vaccination status could be challenging if the pediatric provider does not receive the 

maternal record

▪ Verbal report of vaccines received during pregnancy may not be reliable1

▪ Pediatric providers may need to make decisions on nirsevimab administration with 

incomplete information on maternal vaccination status

Pediatric Provider Role in Immunization Decisions

1. Tdap Vaccination Coverage During Pregnancy — Selected Sites, United States, 2006–2015 | CDC
▪ State IIS vary in adult immunization capture

▪ Pregnancy status not identified in IIS, though could potentially consider RSV vaccine 

administrations in adult women (<age 60 years) as a proxy

▪ Unable to link maternal and infant immunization records in the IIS

– Clinical Decision Support for immunization unable to take into account maternal 

vaccination history for forecasting for infant nirsevimab immunization

– Some state IIS policies limit ability of pediatric providers to review adult records, or 

records for individuals who are not their patients

Immunization Information Systems (IIS)
▪ Terminology: Vaccine (maternal product) vs. 

Immunization (infant product)

▪ Conveying potential risks and benefits of each 

approach, and helping the pregnant person make an 

informed decision

– Including potential but undetermined risk of preterm birth with 

maternal immunization

▪ Discussing financial implications to patient in setting of 

uncertainties about coverage during the first year of 

implementation

Communications Challenges
▪ Formative Research and Message Testing:

– Focus groups and in-depth interviews with pregnant people and prenatal health 

providers (in progress)

– Surveys with parents of young children and pregnant and recently pregnant people

▪ Patient and provider education materials

▪ Digital partnerships with healthcare provider organizations

▪ Partnerships with organizations that serve pregnant people

▪ Social media across CDC’s platforms

Communications Activities
Thank You