Document text
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
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 challengesMaternal 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 componentPfizer 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 spaceSupplied 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 immunization2Cost 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 full -
benefit 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 costInsurance 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 nirsevimabSupply 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 role2Obstetric Provider Role in Immunization Decisions
1.Lutz C, et al. Understanding barriers and predictors of maternal immunization: Identifying gaps through an exploratory litera ture 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 statusPediatric 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 patientsImmunization 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
implementationCommunications 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 platformsCommunications Activities
Thank You