The United States Food and Drug Administration has approved an antibody that protects infants from respiratory syncytial virus, or RSV.
In the United States, RSV infections are the leading cause of hospitalization for children under a year old.
Nirsevimab is an injectable antibody that is given to infants before the start of the RSV season. The antibody binds to the virus and prevents it from spreading to healthy cells. It will be sold by Sanofi under the name brand Beyfortus.
The FDA said infants up to 24 months old can receive a second injection if needed.
"Today's approval marks an unprecedented moment for protecting infant health in the U.S., following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system. Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season. I am proud that, by prioritizing this potential game-changer, we are now about to bring Beyfortus to American families," Thomas Triomphe, Sanofi Executive Vice President of Vaccines, said in a press release.
Before the new treatment can be distributed, it has to be recommended by the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices. They are scheduled to meet on August 3rd and are expected to recommend the antibody. They will also vote on whether it should be added to the Vaccines for Children program, which would require the federal government to pay for the treatment for children who do not have health insurance.
After the committee makes its recommendation, the CDC will then make the final decision on whether to approve the antibody treatment.