For RSV vaccines, including ABRYSVO®*, equivalence between different lots of the same product Is shown via the “a 1.5-fold criterion”. For each lot:lot, comparison the 95% CIs and GMRs must fall within
the interval [0.667, 1.5].
Per FDA. “The primary immunogenicity objective of the study was achieved. For both RSV-A and RSV-B, each pair of between-lot comparisons from the 3 vaccine lots met the predefined 1.5-fold equivalence criterion (2-sided 95% CI for each between lot geometric mean ratio (GMR) was contained in the interval 0.667 to 1.5) for the evaluable immunogenicity population. Subgroup analyses by sex showed similar results for females and males for both RSV-A and RSV-B.”
*FDA Approved May, 2023 for
•Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. (1.1)
•Active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older. (1.2)
•Active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. (1.3)
Package insert Revised: 10/2024
https://www.sciencedirect.com/science/article/pii/S0264410X24003876?via%3Dihub
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