FDA Approves World's First RSV Vaccine for Older Adults
4 May 2023 • After a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV. On Wednesday, May 3rd, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
In a pivotal clinical trial of nearly 25,000 older adults, the results of which were published in the New England Journal of Medicine, the Arexvy vaccine was 83% effective at preventing lower respiratory tract disease caused by the virus. The vaccine was 94% effective at preventing severe disease in seniors.
The FDA said it is requiring GSK to continue to monitor for signs of Guillain-Barré syndrome. The FDA says two people in the clinical trials for the vaccine developed the condition after getting that shot along with an influenza vaccine. Three other RSV vaccines for older adults are also in the final phases of testing.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening"
Source: FDA | Read full story