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Maternal RSVpreF Vaccine: A Novel Agent for Respiratory Syncytial Virus Prevention in Infants
J Hunter Fly1,2, Jeremy S Stultz3, Lea S Eiland4
1Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, TN, USA.
Insights
Maternal immunization with the RSVpreF vaccine significantly reduces infant respiratory syncytial virus (RSV) lower respiratory tract infections. This new maternal vaccine is well-tolerated and offers crucial protection for infants against RSV.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Respiratory syncytial virus (RSV) is a major cause of infant respiratory illness.
- Maternal immunization is an emerging strategy for infant disease prevention.
- RSVpreF is a novel vaccine candidate for maternal administration.
Purpose of the Study:
- To summarize data on the safety and efficacy of the RSVpreF vaccine administered during pregnancy for infant protection.
- To compare RSVpreF with existing RSV prevention strategies.
Main Methods:
- Literature search of PubMed using "RSVpreF" and "pregnancy."
- Inclusion of clinical trials on maternal RSVpreF administration.
- Review of organizational guidelines, medication labeling, and regulatory presentations.
Main Results:
- RSVpreF demonstrated a significant reduction in medically attended RSV lower respiratory tract infections (MA RSV-LRTI) in infants.
- The vaccine showed a 69.4% reduction in severe MA RSV-LRTI and a 51.3% reduction in MA RSV-LRTI at 180 days post-birth.
- No statistically significant increase in preterm births was observed with RSVpreF administration.
Conclusions:
- Maternal immunization with RSVpreF effectively reduces infant MA RSV-LRTI, severe MA RSV-LRTI, and RSV-associated hospitalizations.
- The RSVpreF vaccine is well-tolerated in pregnant individuals.
- Ongoing evaluation of adverse events is part of post-marketing surveillance.
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.
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