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Ask Dr. Nandi: New RSV antibody treatment for infants approved by the FDA

RSV Vaccines
Posted at 4:03 PM, Jul 17, 2023
and last updated 2023-07-17 18:05:42-04

(WXYZ) — A new antibody to protect babies and toddlers from RSV has been approved by the Food and Drug Administration.

This new shot could be a game-changer as RSV, or respiratory syncytial virus, is the No. 1 reason why infants end up hospitalized in the U.S.

It’s called Nirsevimab and it’s an antibody, not a vaccine. Vaccines teach the immune system how to recognize a specific germ and fight it off. Whereas with this antibody, it’s designed to bind to a specific protein on the surface of the RSV virus and stop it from infecting cells.

Now, the antibody is a single injection and the FDA approved it for use in all infants. Babies can get the shot just before their first RSV season, which usually kicks off in the fall. In addition, children up to 24 months who are more vulnerable to RSV may get a second shot to help protect them through their second RSV season.

This is excellent news because RSV can be pretty hard on newborns. Distraught parents end up at the ER with a baby who is struggling to breathe. That’s because RSV is the leading cause of bronchiolitis, which is inflammation of the lung’s small airway. Babies have small airways and it only takes a little swelling and extra secretions in their breathing tubes, and next thing you know, they have restricted airflow. Now, death from RSV is rare, but unfortunately, between 100 and 300 babies die annually due to this virus.

I expect this new antibody is going to cut back on the number of hospitalized infants due to RSV. Because clinical trials found Nirsevimab about 70% effective at lowering the risk that a newborn would need medical attention and 78% effective at preventing hospitalization.

As for comparing Nirsevimab to the other antibody, Palivizumab, the two are very different. Palivizumab has been found to keep babies out of the hospital about 50% of the time. So a lower efficacy rate than Nirsevimab. And Palivizumab is a monthly shot given during the RSV season to vulnerable infants born preterm or with lung and congenital heart conditions. Whereas Nirsevimab is given to all babies and the protection lasts about four to six months.

The shot was also well tolerated with minimal side effects - for example, a skin reaction at the injection site that went away on its own. And the best news is that Nirsevimab will likely be ready this fall, assuming the CDC approves it next month.