According to a study published in JAMA Network Open, maternal respiratory syncytial virus prefusion F (RSVpreF) vaccination may reduce and prevent hospitalizations among infants with RSV-associated acute respiratory illness (ARI) and lower respiratory tract disease (LRTD), particularly within the first 90 days of life.
RSV, or respiratory syncytial virus, is the primary cause of acute lower respiratory infection in infants, with about 33 million cases worldwide each year. In 2019, there were 26,300 RSV-associated acute lower respiratory infection in-hospital deaths and 101,400 RSV-attributable overall deaths in infants aged 0 to 60 months.
RSV disproportionately affects children of color, especially Black children. In 2013, one study found that Black children had higher hospitalization rates of RSV than white children and were more likely not to have insurance to cover the costs.
In August 2023, the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine was FDA-approved and licensed in the United States to reduce RSV-associated lower respiratory tract disease in infants through maternal immunization. This retrospective case-control study was set to determine the efficacy of the maternal RSVpreF vaccination, specifically for infants aged 90 days or younger.
This study analyzed data from the University of Pittsburgh Medical Center during the RSV seasons of 2023 to 2024 and 2024 to 2025. It included 83 infants with RSV and 191 infants negative for RSV (controls) for a total of 274, born between October 1, 2023, and April 15, 2024, or between September 1, 2024, and April 30, 2025. All infants were hospitalized with ARI and then tested for RSV.
The average age of the infants at the beginning of the study was 29.5 days. Of the 274 infants, 13.5 percent were Black, 62.4 percent were white, 2.2 percent were Asian, 1.5 percent were of other races, and 20.4 percent were of unknown race or declined to answer. About 52 percent of the infants were male, and 48 percent were female.
Maternal RSVpreF vaccination was administered at gestational age between 32 weeks 0 to 7 days, 36 weeks 6 to 7 days, and at least 14 days before delivery.
It should be noted that a number of the study’s authors are reported to be connected with Pfizer Inc., which funded the study and manufactured the vaccine. The pharmaceutical company supported many authors with grant money, while others were employees or stockholders.
According to the authors, the study’s findings provided “early clinical evidence supporting the effectiveness of maternal RSVpreF vaccination in preventing RSV-associated hospitalization in infants.”
Of the 83 infants with an ARI diagnosed as positive with RSV, 13.3 percent (11) were born to mothers vaccinated with the maternal RSVpreF. Of the 191 RSV-negative infants with an ARI, 37.2 percent (71) were born to mothers vaccinated with the maternal RSVpreF.
According to the study, the estimated effectiveness of the vaccination against RSV-associated ARI hospitalization was 67.6 percent, and against RSV-associated LRTD hospitalization was 69.0 percent, for infants 0 to 90 days old. Vaccine effectiveness against RSV-associated ARI hospitalization was estimated to be 74.2 percent for infants 0 to 30 days old.
For Black families, this type of maternal vaccine could be vital to the health of their infants. If a Black mother is delivering her child within the critical seasons of RSV, providers can recommend the maternal RSVpreF vaccination to help prevent future complications. The study found that infants with RSV were more likely to be born between October and December, be male, and be Black.
Providers must take action to recommend and support their patients by educating them on vaccine opportunities. For mothers who did not receive the maternal vaccine, monoclonal antibody immunization (nirsevimab or clesrovimab) is also an alternative recommended by the Centers for Disease Control and Prevention (CDC).
The CDC reports that Black pregnant women have the lowest rates of vaccination coverage compared to other racial and ethnic groups. They are also less likely to receive vaccination recommendations from their providers. This is not the fault of the women but of the medical systems in which they seek care.
For providers, this study’s findings emphasize the importance of educating patients on the efficacy of certain vaccines. This is especially relevant when it comes to caring for Black pregnant women, whose children face a higher risk of RSV — this vaccine is vital for them. This study highlights the need for improved public health education, community-based initiatives, and overall health literacy across all patient communities.
“These findings suggest maternal RSVpreF vaccination provides clinical protection against RSV-associated hospitalization in early infancy; however, continued data collection is critical to refine vaccine effectiveness estimates,” wrote the authors.
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