U.S. regulators on Wednesday approved the
first vaccine
to prevent respiratory syncytial virus (RSV).
The GSK-developed vaccine, known as Arexvy, could become available to treat seniors as soon as this fall.
-
Researchers in February
published the results
of a Phase 3 vaccine trial that included 25,000 participants aged 60 years or older.
- The vaccine was 83% effective at preventing RSV-associated lower respiratory tract disease among the study's participants.
- The U.S. Food and Drug Administration approved a single-dose regiment of the vaccine for adults 60 years and older.
- The vaccine still needs to gain approval from the U.S. Centers for Disease Control, which is scheduled to meet in June.
-
A decade ago, the U.S. National Institutes of Health discovered how to
freeze F proteins
into the shape they take before entering a cell.
-
GSK
employs F protein technology
in its vaccine along with a substance known as an adjuvant to increase immune activity.
-
RSV kills
100-300 children under five
and about 6,000 to 10,000 adults over 65 in the U.S. every year.