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September 27, 2023
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Q&A: What to know about new RSV immunizations for infants

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Key takeaways:

  • The CDC has now recommended two prevention methods for RSV in babies: a maternal vaccine and a monoclonal antibody.
  • The measures are expected to reduce a majority of RSV illness among infants.

The CDC last week recommended Pfizer’s respiratory syncytial virus vaccine for pregnant people to protect newborns from severe RSV illness.

The recommendation came a month after the FDA approved the vaccine as a single intramuscular injection given at 32 through 36 weeks’ gestational age.

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After years of trying, there are now two RSV vaccines available for older Americans, and two options to protect infants: the Pfizer vaccine and the monoclonal antibody nirsevimab, which was recommended by the CDC in August.

We spoke with Lori Handy, MD, MSCE, an attending physician in the division of infectious diseases at The Children’s Hospital of Philadelphia (CHOP) and associate director of the hospital’s Vaccine Education Center, about the recommendation and what they mean for patients and providers.

Healio: There is now an immunization — the monoclonal antibody nirsevimab — and a vaccine to protect infants against severe RSV. Can you describe this moment in terms of what it means for infant health in the U.S.?

Handy: RSV is an infection that impacts virtually all children. One or two of every 100 children will be hospitalized with a lower respiratory tract infection caused by RSV in the first 6 months of life, and virtually all children are infected with RSV at least once by the time they are 24 months of age. Between 100 and 300 children die each year because of RSV.

This year, we have gained two prevention measures that are anticipated to reduce a majority of this morbidity — this season, we can protect our youngest patients through use of maternal vaccination, which will lead to passage of maternal antibodies to babies, or direct immunization of babies with a preventive medication, nirsevimab. These are not niche medications or preventive measures for a rare disease — these have the ability to help virtually all young infants, and also help our health care systems that typically are strained during surges in respiratory illness.

Healio: The CDC said most infants will probably need only one or the other but noted a scenario in which both may be needed: if a baby is born less than 2 weeks after maternal immunization. Do you think physicians are ready to make these decisions?

Handy: There are known implementation challenges with both the maternal vaccine and the monoclonal antibody for children. Pediatricians may not be able to access a maternal vaccine record and may have to rely on parental report. Documentation of maternal vaccine status in a systematic way will also need to occur.

Reassuringly, there will be no harm to a baby if they receive nirsevimab in a circumstance where a pediatrician does not know the status of the mother. However, we do need to consider how payers will manage these circumstances, and we hope that commercial insurance companies will quickly make their plans transparent so there is not an unforeseen financial burden for families.

Healio: What kind of tools are available for pediatricians and other physicians to help them navigate questions about the timing and need for COVID-19, influenza and RSV vaccines this fall?

Handy: The CDC as well as the AAP have been updating online resources and supplementing with frequently asked questions. There are also a number of webinars on these topics from both the CDC and AAP that will help health care providers understand the nuances of these recommendations.

CHOP continues to keep information updated on our family-facing website, chop.edu, and the Vaccine Education Center. This information is accessible to both health care providers and families to make informed decisions this fall.

Although there are many implementation challenges to be overcome within an office setting to begin offering nirsevimab, one of the biggest challenges we are seeing is understanding payor reimbursement. Reassuringly, Vaccines for Children (VFC) will provide this medication to all infants eligible for VFC. However, we hope that commercial insurance companies will quickly figure out how to pay for nirsevimab in both the primary care and birth hospitalization setting so that we can protect as many infants as possible from being infected with RSV this season.

References:

AAP. Nirsevimab frequently asked questions. https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/nirsevimab-frequently-asked-questions/. Last updated Sept. 26, 2023. Accessed Sept. 27, 2023.

CDC recommends new vaccine to help protect babies against severe respiratory syncytial virus (RSV) illness after birth. https://www.cdc.gov/media/releases/2023/p0922-RSV-maternal-vaccine.html. Published Sept. 22, 2023. Accessed Sept. 26, 2023.

CDC. Respiratory syncytial virus (RSV) immunizations. https://www.cdc.gov/vaccines/vpd/rsv/index.html. Last reviewed Aug. 30, 2023. Accessed Sept. 27, 2023.

Children’s Hospital of Philadelphia. A look at each vaccine: Respiratory syncytial virus (RSV) vaccine and monoclonal antibody. https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-details/rsv-vaccine-monoclonal-antibody. Last reviewed Aug. 22, 2023. Accessed Sept. 27, 2023.