FDA Advisors Vote in Favor of New RSV Vaccine

The FDA’s scientific advisors voted in favor of recommending a new RSV vaccine given to pregnant mothers in order to protect their infants. The ultimate decision on whether to approve the vaccine will be made at later date by FDA officials. The vaccine produces an immune response in the mother, who then passes on these protective antibodies to their child through the placenta – the same way babies receive protection from other viruses and bacteria in the womb. The vaccine is given between the 24th-36th week of pregnancy. The advisors all the vaccine In clinical trials, the vaccine was 82% effective at preventing severe in babies up to 3 months old and 69% effective by 6 months of age. Based on a detailed analysis of the data, all committee members concluded that the shot is effective at preventing severe RSV illness in babies younger than 6 months. The majority of advisors (10 out of 14) determined that vaccine is safe. In the clinical study, there was a small difference in premature births in the group that received the vaccine versus the group the dummy shot (placebo). The panel engaged in a lengthy discussion over whether the higher premature birth rate was caused by the shot or if this difference was due to chance. In February, the FDA advisors also voted in favor of Pfizer’s vaccine for older adults. The agency officially approved a separate RSV vaccine developed by GSK, making it the first-ever RSV vaccine to gain approval. These vaccines have the potential to save thousands of deaths and hospitalizations per year. The virus sends 58,000-80,000 children under 5 years old to the hospital each year. In addition 60,000-160,000 Americans age 65 and older are admitted to the hospital with RSV. Between 6,000-10,000 of these older adults die. GSK’s vaccine is expected to be available sometime this Fall.

Full Story: Associated Press,