First Drug for Protecting Infants Against Respiratory Syncytial Virus Approved in the U.S.

The U.S. Food and Drug Administration has approved the first drug to protect infants against respiratory syncytial virus (RSV) in the form of an injection. The RSV virus sends approximately 60,000 to 80,000 children to the hospital each year in the U.S. and causes the deaths of 300 children under the age of five annually. The FDA announced that the antibody-based drug 'Nirsevimab' marketed as 'Beyfortus' by Sanofi and AstraZeneca has shown in trials that it can prevent 70 to 75 percent of respiratory infections caused by the virus. The RSV season lasts from fall to winter, typically spanning five months. Until now, most children had to fight off infections from this virus relying solely on their immune systems. Before the approval of the new injection, only premature infants or those under six months at high risk for severe disease were eligible for another drug called 'Synagis.' RSV is a common virus but received less attention until cases surged last fall and winter, occupying hospital beds. This virus affects the lungs and airways of infants and adults, often causing mild cold-like symptoms but can also lead to severe illnesses such as bronchitis or pneumonia. The new drug 'Beyfortus' is not a vaccine but has a similar structure, providing pre-formed antibodies to infants whose immune systems have not yet developed enough to combat the virus. Unlike a vaccine that prompts the immune system to produce antibodies against the virus, this drug does not require the immune system to produce anything. According to FDA guidelines, infants can receive this injection at the start of the RSV season or at birth if it falls within the RSV season. In May, the FDA approved the first vaccines against RSV from GSK and Pfizer for individuals over 65 years old, with the virus claiming the lives of about 14,000 people over 65 each year, often contracted from their grandchildren. Pfizer is currently awaiting approval for another RSV vaccine for pregnant women aimed at protecting infants.