FDA approves first vaccine against RSV
The Food and Drug Administration approved the first vaccine Prevention of diseases of the lower respiratory tract caused by Respiratory syncytial virus for adults 60 years and older on Wednesday.
RSV is a common and contagious virus that causes infections in the lungs and airways. According to the Centers for Disease Control and PreventionMost people with RSV experience mild, cold-like symptoms that take a week or two to recover from.
GSK’s single-dose vaccine Arexvy could be available in the fall for people aged 60 and over, a population at higher risk of developing serious RSV disease. CNN reports. However, the CDC’s Advisory Committee on Immunization Practices must still recommend its use.
“Older adults, particularly those with underlying health conditions such as heart or lung disease or compromised immune systems, are at high risk for serious RSV disease.” Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in a press release On Wednesday.
according to CDC, Every year in the United States, 6,000 to 10,000 adults age 65 and older die from RSV. RSV is also common in children, with 100 to 300 deaths in children under the age of 5 each year. The virus is also the leading cause of pneumonia and bronchiolitis in children under the age of 1 in the United States
The FDA approval follows the “tripledemic” increase in RSV, COVID-19 and flu cases in late 2022.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease that can be life-threatening and reflects the FDA’s continued commitment to developing safe and effective vaccines for use in the United States states,” Marks said in the press release.
Accordingly CNN, the vaccine has been in the works for 60 years. A clinical study found that the vaccine was 83% effective in protecting against lower respiratory tract disease caused by RSV and 94% effective in preventing serious illness in the elderly.
The FDA press release said that in one study, some of the 2,500 participants received Arexvy concurrently with the FDA-approved influenza vaccine, two participants developed a rare type of inflammation affecting the brain and spinal cord called acute disseminated encephalomyelitis.
Another study of 2,500 participants found that after taking Arexvy, one participant developed Guillain-Barré syndrome — a rare condition in which the body’s immune system damages nerve cells, which can lead to muscle weakness and even paralysis.
According to the press release, the FDA is requesting that GSK conduct a post-marketing study to further assess the risks of Guillain-Barré Syndrome and ADEM.