Vaccine Info

RSVpreF RSV Vaccine

RSVpreF RSV Vaccine Description

RSVpreF vaccine candidate is based on the prefusion form of the RSV fusion protein, aided by the discovery of the crystal structure of key viral proteins by the National Institutes of Health.

The vaccine is designed to stimulate the production of serum anti-F immunoglobulin G in the pregnant woman, which can then be transferred to the fetus across the placenta and provide protection for the first six months of life when the risk of hospitalization is highest.

RSVpreF RSV Vaccine Indication

RSVpreF RSV vaccine candidate is indicated for healthy pregnant women to provide protection for the first six months of the infant's life when the risk of hospitalization is highest.

RSV is a virus that can cause severe respiratory disease in infants and older adults.

Globally, there are an estimated 33 million cases of RSV annually in children less than 5 years of age, with about 3 million hospitalized and approximately 120,000 dying each year from complications associated with the infection.

Nearly half of these pediatric hospitalizations and deaths occur in infants less than 6 months of age.11. 

RSVpreF RSV Vaccine News

June 22, 2020 - First subjects recently administered immunizations in two studies of 20-valent pneumococcal conjugate vaccine candidate in infants; a pentavalent meningococcal vaccine candidate in adolescents; and a respiratory syncytial virus vaccine candidate in pregnant women

April 2020 - positive top-line results were achieved for a Phase 2b proof-of-concept study of RSVpreF, which evaluated the safety, tolerability, and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants. Detailed results from the study will be shared at a future medical conference.

November 2018 - FDA granted Fast Track status to RSVpreF for the prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.

RSVpreF RSV Vaccine Clinical Trials

Clinical Trial NCT04424316: A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy

  • This Phase 3 trial of RSVpreF is a global, double-blind, placebo-controlled study that will enroll 6,900 pregnant women ages 18 through 49 and their infants.