The FDA approves the first-ever vaccine against the RSV virus, which kills 10,000 Americans every year
The first-ever vaccine against the common winter beetle respiratory syncytial virus has been approved by the Food and Drug Administration.
In clinical studies, Arexvy was more than 84 percent effective against lower respiratory tract infections and 94 percent effective against serious diseases in this area.
It works by exposing the immune system to proteins from the surface of the virus and triggering the production of antibodies.
Respiratory syncytial virus (RSV) kills about 10,000 American adults each year and can also cause serious illness in young children. Scientists have struggled for decades to develop a vaccine against it after several failed attempts.
The first-ever vaccine against a common winter virus has been approved by the Food and Drug Administration.
The FDA today gave the go-ahead for the vaccine to be given to adults age 60 and older.
It must now be recommended for use by the Centers for Disease Control and Prevention (CDC) before it can be made available to the public.
It was not clear if approval would be extended to children, but other RSV vaccines are in development for this age group. One made by Pfizer is expected to be approved later this year.
Developed by British pharmaceutical giant GSK, Arexvy is given to patients as a single dose to protect against sparks.
The FDA approval was based on a study of 25,000 patients who received either Arexvy or a placebo.
The study is planned to run for three RSV seasons, with approval based on data from the first year of the study.
It was not clear if participants could be offered booster doses later.
Side effects of the injection included pain at the injection site, fatigue, muscle pain, headache, and joint stiffness.
Ten vaccine recipients also experienced atrial fibrillation or an irregular heartbeat.
In two other studies of the vaccine, two participants had encephalitis and one had Guillain-Barré syndrome, a rare condition in which the body’s immune system damages cells.
Announcing the drug’s approval, Dr. Peter Marks, a director of the FDA, said this was a “major public health achievement.”
“Older adults, particularly those with underlying health conditions such as heart or lung disease or a compromised immune system, are at higher risk for serious RSV disease.
‘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 to facilitate.’
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