New Data (July 8, 2024) for Maternal RSV Vaccine

Dr. Chapa’s Clinical Pearls.

RSV season is just around the corner (Fall and Winter months). Newborns are 16x more likely to be hospitalized with serious RSV lung infection than the flu. On August 21, 2023, the FDA approved the first RSV vaccine, Abrysvo, for use in pregnant individuals to protect newborns and infants against severe RSV disease in the first 6 months after birth. The FDA approved the vaccine to be administered between 32 and 36 weeks and 6 days of gestation. Then, on September 22, 2023, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend a single dose of maternal RSV vaccination for pregnant people at 32 through 36 weeks of gestation, using seasonal administration, to prevent RSV lower respiratory tract infection (LRTI) in infants.This resulted in the ACOG’s endorsement, also in September 2023, of Abrysvo in pregnancy. However, the clinical trial resulting in the vaccine’s FDA approval noted “a numerical imbalance” for preterm birth occurrence (1% more) in vaccine recipients. Because of this, there was a call for additional “real world outcomes“ to see if this finding would be replicated outside of the trial. In this episode, we will summarize a brand new (July 8, 2024) publication from JAMA Network Open which provides this data, although some noteworthy study limitations must be acknowledged. Listen in for details!