Pregnancy vaccine shields newborns from RSV: Real-World data reveals impact

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Test Negative Design Inclusion Criteria: 1. Infants ≤9 months (≤270 days) of age on the index date. 2. Index date within the time period for data collection (approximately 01 April to 30 September in 2024, 2025, or 2026). 3. Infants born at 32 weeks of gestational age or greater. 4. Hospitalized for at least 24 hours with LRTD (symptoms related to LRTD might be absent at the time of admission but if they develop within the first 24 hours of hospitalization, the criteria for LTRD will be considered met), and specimen collected for RSV within 10 days prior to hospital admission through 3 days after a hospital admission through SOC testing. 5. Infant date of birth 14 days or more after start of the first seasonal ABRYSVO vaccination campaign, to ensure potential to have been born to an ABRYSVO-vaccinated individual. 6. Infant born to individuals who were expected (based on estimated date of delivery) to reach the indicated ABRYSVO vaccination window (320/7 to 366/7 weeks' gestation) during a local ABRYSVO vaccination season. Test Negative Design Exclusion Criteria: 1. Received any licensed or investigational RSV preventive product (e.g., Palivizumab, Nirsevimab, active RSV vaccine) since birth. 2. Received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth. 3. Born to individual who received any other licensed or investigational RSV vaccine during pregnancy. 4. Born to individual for whom ABRYSVO vaccination status cannot be confirmed in available data sources. 5. Infants with LRTD that require hospitalization for reasons other than clinical criteria (e.g., for social reasons, other medical condition in an infant with LRTD without hospitalization criteria). Cohort Design Inclusion Criteria: 1\. RSV positive cases ≤9 months of age from the TND study. Cohort Design Exclusion Criteria: None. Ecologic Before-and-After Design Inclusion Criteria: 1. Infants and children ≤24 months of age on the index date. 2. Index date during the calendar years for data collection (pre- or post-ABRYSVO program implementation. 3. Meets ≥1 outcome definition during the time period for data collection. Ecologic Before-and-After Design Exclusion Criteria: None.