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FDA approves RSV vaccine for infants

FDA approves RSV vaccine for infants


The U.S. Food and Drug Administration (FDA) approved a vaccine against the RSV (Respiratory Syncytial Virus) for infants under the age of one and for children up to two years old with underlying health conditions or risk factors.

The vaccine, Beyfortus, will be administered in a single dose and is expected to be available worldwide before the next winter season.

RSV may not be well-known to many, but its spread affects thousands of families every winter in Israel and around the world. RSV is a highly contagious virus that causes respiratory illnesses, primarily affecting the upper respiratory tract. Nearly all children up to the age of two will contract it at least once in their lives. A significant increase in RSV cases in Israel was observed in the past winter.

The spread of the virus, similar to other respiratory viruses, occurs when an infected person coughs or sneezes in close proximity to others. Infection can also happen through close contact, touching eyes, nose, or mouth, or after touching a surface contaminated with the virus.

Infants infected with the virus may experience symptoms like fever, cough, and shortness of breath. In some cases, a visit to the doctor’s office or even hospitalization might be necessary. During the winter season, a significant portion of pediatric ward bed occupancy is due to RSV, which is responsible for a quarter of hospitalizations of infants and toddlers due to pneumonia.

An existing RSV vaccine was available only for the high-risk population, specifically for infants and young children who were more susceptible to respiratory complications due to RSV infection. The vaccine requires five doses administered as injections to protect this vulnerable population, but it is expensive and requires parents to visit health clinics monthly to vaccinate their child.

The FDA’s approval of the new vaccine is based on studies conducted by pharmaceutical companies AstraZeneca and Sanofi, demonstrating that its use reduces overall hospitalizations by 70% and the rate of high-risk hospitalizations by 80%. Israel’s Pediatric Association recommended the vaccine for infants under the age of one.


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