FDA's greenlighting of maternal RSV vaccine represents a major step forward in protecting young babies against the virus
RSV is the most common cause of lower respiratory infections in young children and can be especially severe for infants under 6 months of age.
- RSV is the most common cause of lower respiratory infections in young children and can be especially severe for infants under 6 months of age.
- It is the leading cause of infant hospitalization in the U.S., according to the Centers for Disease Control and Prevention.
- Each year, RSV is associated with half a million emergency room visits, nearly 100,000 hospitalizations and 300 deaths in young U.S. children.
- The approval of a maternal vaccine and monoclonal antibody signals a major milestone in the medical profession’s ability to prevent RSV disease in children.
A game-changer in the fight against RSV
- Abrysvo stimulates the mother’s immune system to produce antibodies that cross the placenta and offer protection to the newborn against RSV illness, starting at birth.
- In the trial, the maternal RSV vaccine prevented 82% of severe lower-respiratory illnesses caused by RSV in infants in the first 3 months of life, and 69.4% through 6 months of age.
- Abrysvo was also approved by the FDA in May 2023 to prevent RSV illness in adults 60 years and older.
Monoclonal antibodies also provide protection
- For those who are unable to get the RSV vaccine during their pregnancy, there is also an option to provide ready-made antibodies to protect the baby.
- These antibodies help protect against lower-respiratory tract disease, including bronchiolitis and pneumonia, caused by RSV.
Parsing the differences
- Clinical trials showed that the vaccine was protective up to 6 months of age and the antibody up to 5 months of age.
- While Abrysvo stimulates the production of the mother’s own antibodies that get passed on to the baby, Beyfortus is not actually a vaccine.
- It instead provides ready-made antibodies given as an injection to protect the child.
- The cost of Abrysvo and how it will be covered by insurance will depend on what the CDC says in October.
The bottom line
- Both products are safe and effective, and it is important to protect young infants and children at risk from RSV.
- Until now, effective monoclonal antibodies were only available for the most premature babies.