The vaccine developed by AstraZeneca and Sanofi to protect newborns and toddlers against respiratory syncytial virus, the most common reason for infant hospitalization in the US, received approval from the Food and Drug Administration on Monday.
Nivolumab, marketed as Beyfortus, has been given FDA approval just before the autumn RSV season.
In August, a group of impartial experts from the Centers for Disease Control and Prevention will convene to discuss suggestions on how the shot ought to be given by medical professionals.
A different shot called palivizumab is already available, but it is often administered to newborns who are preterm or who have congenital heart and lung abnormalities that place them at a high risk of developing serious illness.
A single injection can also be used to give nirsevimab. Compared to palivizumab, which is given every month during the RSV season, this is a significant advantage.
Before or during an infant’s first RSV season, nirsevimab is given. During their second RSV season, infants up to two years old who are still at risk can also receive the vaccine.
RSV Emerges as Leading Cause of Hospitalization in Infants and Toddlers
According to a report published in the medical journal JAMA Open Network last year, RSV is a serious public health hazard that kills up to 100 infants every year.
According to a study published in the Journal of Infectious Diseases, the virus is the main reason for hospitalization among kids under a year old.
Children’s hospitals across the US were swamped by an increase in RSV infections last fall, which prompted calls for the Biden administration to declare a public emergency.
According to an FDA evaluation, nirsevimab was up to 75% effective in reducing lower respiratory tract infections in infants that required medical attention and 78% effective in preventing hospitalization.
In May, the Pfizer vaccine was recommended by the FDA’s outside consultants. In August, the agency is anticipated to make a final determination regarding whether to authorize the shot.