Vaccine for pregnant women against bronchiolitis virus a milestone for pediatrics
Equipo Ciencia was one of the sites of the study to evaluate the efficacy and safety of a vaccine against respiratory syncytial virus (RSV) in infants born to women vaccinated during the last trimester of pregnancy.
The objective of the study in infants was to evaluate the efficacy of this vaccine in reducing acute lower respiratory infections (ALRI) caused by RSV and in reducing severe acute lower respiratory infections caused by RSV. The vaccine is given to pregnant women who transfer the antibodies to newborns with a strong immune response.
The research work was conducted at the Central Military Hospital between 2021 and 2023 and proved that the vaccine protects against RSV-A and RSV-B variants. The design of this study was randomized, double-blind, and placebo-controlled. This means that half of the pregnant women randomly received the investigational vaccine and the remaining half received placebo (physiological solution), with neither physicians nor participants knowing which substance was administered to which individual. This method is used to ensure impartiality in the evaluation of the results.
About 15,000 pregnant women worldwide participated in the study. 15,000 pregnant women worldwide, They were given a single intramuscular dose of the stabilized prefusion subunit F vaccine against respiratory syncytial virus. In our network sites in our network involved more than 400 pregnant 49 years of age or younger, who were in an uncomplicated pregnancy of 24-36 weeks gestation at the time of immunization.
In relation to the safety objectives, local and systemic adverse effects were analyzed after 7 days and 1 month post-vaccination in the mother; as well as in the newborn within 1 month. The preF RSV vaccine has demonstrated a favorable safety profile for mothers and their infants. Most adverse events in mothers were mild to moderate, the most frequent in pregnant women was pain at the injection site.
The efficacy of the vaccine against acute respiratory infection (ARIB) due to severe RSV was 82% at 3 months and 69.4% at 6 months. In relation to RSV hospitalization up to 180 days, the statistical criteria for success were met, with 67.7% and 56.8% for 3 and 6 months, respectively.
This vaccine is included in the mandatory national vaccination schedule since March 2024 and was authorized by the National Administration of Medicines and was authorized by the National Administration of Medicines, Food and Medical Technology (ANMAT) in our country in September 2023. It had previously been approved by the Food and Drug Administration (FDA) of the United States and by the European Medicines Agency (EMA).
