Respiratory syncytial virus (RSV) is a common respiratory virus that can cause serious illness in young children, especially premature babies, and those with underlying health conditions. However, the FDA recently approved a drug to prevent RSV in babies and toddlers as well as the first vaccine for pregnant patients. Learn more about how these developments could help address the heavy burden facing our youngest patients and their families.
Respiratory syncytial virus (RSV) is a common respiratory virus that can cause serious illness in young children, especially premature babies and those with underlying health conditions. It’s the most common cause of bronchiolitis and pneumonia in children younger than 1 year of age in the United States. And according to the Centers for Disease Control and Prevention (CDC), RSV leads to approximately 60,000-120,000 hospitalizations and 2,000 deaths among children under the age of 5 in the US each year.
Given the heavy burden RSV can have on our youngest patients and their loved ones, much attention has been focused on developing preventative treatments, and now, two new options are available.
Preventing RSV in Infants
The US Food and Drug Administration (FDA) has recently approved a new drug to prevent RSV and lower respiratory tract disease in babies and toddlers. This is the first drug approved for the prevention of RSV and is an important milestone in prevention in this age group.
The drug, Nirsevimab, is a single-dose, long-acting monoclonal antibody that is administered as an injection. It’s approved for use in infants and toddlers who are at high risk of developing severe RSV disease, such as those born prematurely or with certain heart or lung conditions. Nirsevimab works by binding to the RSV F protein, which prevents the virus from entering and infecting cells, thereby preventing RSV lower respiratory tract disease in infants and young children. It’s administered monthly during the RSV season, which typically runs from November to April.
To bring more awareness to this breakthrough, the CDC issued a Health Alert Network (HAN) notice to healthcare providers about the increased RSV activity and the availability of new prevention tools to protect patients. The notice highlights the availability of Nirsevimab as well as other prevention tools, such as hand hygiene, respiratory etiquette, and isolation precautions. The CDC recommends that healthcare providers consider the use of all of these prevention tools to help protect patients from RSV.
Preventing RSV in Pregnancy
In addition to Nirsevimab, the FDA has also approved Abrysvo, the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age. The vaccine is administered to pregnant individuals at 32 through 36 weeks gestational age of pregnancy.
Among approximately 3,500 pregnant individuals who received Abrysvo, compared to approximately 3,500 pregnant individuals who received placebo, Abrysvo reduced the risk of severe LRTD by 81.8 percent within 90 days after birth and 69.4 percent within 180 days after birth. In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, of whom approximately 1,500 received Abrysvo and 1,500 received placebo, Abrysvo reduced the risk of LRTD by 34.7 percent and reduced the risk of severe LRTD by 91.1 percent within 90 days after birth when compared to placebo.
Recapping RSV Treatment Advancements
Overall, the recent approvals of Nirsevimab and Abrysvo to prevent RSV in infants and young children are important developments in the fight against this serious respiratory virus as the availability of these new treatments is expected to provide significant benefits to individuals at high risk for severe disease caused by RSV, particularly infants and young children.
References:
Bendix, Aria. “FDA Approves RSV Injection for Infants.” NBCNews.com, July 17, 2023. https://www.nbcnews.com/health/health-news/fda-approves-rsv-injection-infants-rcna94698.
“FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine.” U.S. Food and Drug Administration, May 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine.
“FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants.” U.S. Food and Drug Administration, August 21, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants.
“FDA Approves New Drug to Prevent RSV in Babies and Toddlers.” U.S. Food and Drug Administration, July 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers.
“Increased Respiratory Syncytial Virus (RSV) Activity in Parts of the Southeastern United States: New Prevention Tools Available to Protect Patients.” Centers for Disease Control and Prevention, September 5, 2023. https://emergency.cdc.gov/han/2023/han00498.asp.
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