Maternal RSVpreF Vaccine: A Novel Agent for Respiratory Syncytial Virus Prevention in Infants.

Abstract

Objective: The objective was to summarize available data regarding the safety and efficacy of RSVpreF in the setting of maternal administration for infant protection against respiratory syncytial virus (RSV) while comparing RSVpreF to other RSV prevention strategies.

Data sources: A literature search of PubMed was conducted utilizing the phrases "RSVpreF" and "pregnancy." Additional references were identified through found sources of information. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.

Study selection and data extraction: Clinical trials investigating RSVpreF administration to pregnant women were included as well as other references on pharmacology, pharmacokinetics, and vaccine uptake.

Data synthesis: RSVpreF vaccine, administered once to pregnant women, demonstrated a 69.4% (97.58% confidence interval [CI] = 44.3 to 84.1) lower incidence of severe medically attended RSV lower respiratory tract infection (MA RSV-LRTI) and 51.3% (97.58% CI = 29.4 to 66.8) lower incidence of MA-RSV-LRTI at 180 days post birth in 1 placebo-controlled study. The RSVpreF vaccine administered at 24 to 36 weeks did not have a statistically significant higher rate of preterm births (relative risk = 1.20; 95% CI = 0.99 to 1.46) across two studies and in postmarketing data.Relevance to patient care and clinical practice in comparison with existing agents:The RSVpreF vaccine is the first maternal vaccine approved by the US Food and Drug administration for prevention of RSV in all infants. When compared with other agents, the optimal prophylaxis agent is unclear.

Conclusions: Maternal immunization with RSVpreF demonstrated a reduction in MA RSV-LRTI, severe MA RSV-LRTI, and RSV-associated hospitalizations for infants. The vaccine is well tolerated, and adverse events continue to be evaluated.