I believe nirsevimab would not be clinical-indicated for all infants and likely would be utilized in high-risk babies with congenital heart or lung disease, such as cystic fibrosis, or those with prior thoracotomies for heart surgery, where respiratory mechanics would be compromised." The FDA committee's positive recommendation for nirsevimab, also known as Beyfortus, comes just weeks after the agency approved GlaxoSmithKline Biologicals' Arexvy, the first-ever RSV vaccine for older adults, and recommended Abrysvo, Pfizer's RSV vaccine for pregnant women. According to CNBC, the FDA is expected to make a final decision on nirsevimab in the third quarter of this year. Nass told The Defender that while the FDA is not obligated to follow the panel's advice, "it almost always does so." FDA: Infant deaths during clinical trial 'unrelated' to the treatment CNBC reported that the FDA review identified no safety concerns with nirsevimab, but also reported that 12 infants died during the trials.