U.S. FDA Approves First RSV Shot For Infants

July 18, 2023
A woman holding a baby

Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.

Dr. John Farley, an official at the United States Food and Drug Administration, which on Monday approved a respiratory syncytial virus (RSV) shot for infants and toddlers ahead of this fall’s RSV season.

What is RSV? Respiratory syncytial virus is common and causes cold-like symptoms. While most people recover, it can be particularly serious for infants and older adults, causing up to 80,000 hospitalizations and around 300 deaths in children under five years old each year in the U.S.; RSV is also the leading cause of hospitalization in infants (children less than one year old).

Why It Matters: On Monday, the FDA approved a treatment called Beyfortus (a shot developed by pharmaceutical company AstraZeneca; will be marketed in the U.S. by pharmaceutical company Sanofi) for prevention of RSV in infants, as well as for children up to two years old "who remain vulnerable to severe RSV disease through their second RSV season." This is the first RSV shot to be approved by the FDA to protect infants against RSV, whether or not they have a medical condition or are healthy (a separate shot is already available to some infants who are more vulnerable to severe disease from RSV). Before the shot can be distributed to the public, the Centers for Disease Control and Prevention's "panel of independent experts will meet in August to make recommendations on how the shot should be administered by doctors," CNBC reports.

More Details:

  • The efficacy of the shot was observed through three clinical trials, with one of the primary groups showing that Beyfortus reduced the risk of RSV in infants by approximately 75% when compared to the placebo group.
  • Beyfortus can be administered before or during an infant's first RSV season (in much of the U.S., RSV season typically begins in the fall and peaks in the winter). Potential side effects of the shot "include rash and injection site reactions," the FDA notes.
  • Beyfortus is a monoclonal antibody. The FDA explains, "Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses." Development and use of monoclonal antibodies dates back roughly 30 years; they have been used to treat certain cancers, autoimmune diseases, multiple sclerosis and beyond.

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

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by Jenna Lee,