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FDA Approves New Drug to Prevent RSV in Babies and Toddlers

RSV is a viral illness that causes symptoms  similar as trouble breathing. It’s the most common cause of inflammation of the small airways in the lungs( bronchiolitis) and pneumonia in babies.  

RSV is spread when a child comes into contact with fluid from an infected person’s nose or mouth. This can be if a child touches a  polluted  face and touches his or her eyes, mouth, or nose. It may also be when  gobbling  driblets from an infected person’s sneeze or cough.  

The most common symptoms of RSV include: (Watery nose, fever, cough, trouble eating and drinking, etc..).

According to FDA news which published 17th July 2023 (U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. )

And about safety of Beyfortus FDA published (The safety and efficacy of Beyfortus were supported by three clinical trials (Trials 03, 04 and 05). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI), evaluated during the 150 days after Beyfortus administration. MA RSV LRTI included all health care provider visits (physician office, urgent care, emergency room visits and hospitalization) for lower respiratory tract disease with worsening clinical severity and a positive RSV test. Trials 03 and 04 were randomized, double-blind, placebo-controlled, multicenter clinical trials.

And Possible side effects of Beyfortus include rash and injection site reactions. Beyfortus should not be given to infants and children with a history of serious hypersensitivity reactions to Beyfortus’ active ingredients or any of its excipients.) And FDA has granted this approval to AstraZeneca.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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