29.05.2024

FDA approves first-ever vaccine for RSV virus which kills 10,000 Americans every year

The first-ever vaccine against the common winter bug Respiratory Syncytial Virus has been approved by the Food and Drug Administration.

Arexvy was more than 84 percent effective at preventing lung infections in clinical trials and 94 percent effective against severe disease.

It works by exposing the immune system to proteins from the surface of the virus, triggering the production of antibodies.

Respiratory Syncytial Virus (RSV) kills about 10,000 American adults every year and can also cause severe disease among young children. Scientists have struggled to develop a vaccine against it for decades amid multiple failed trials.

The first ever vaccine against a common winter virus has been approved by the Food and Drug Administration.

The FDA gave the green light today for the vaccine to be administered to adults aged 60 years and older.

It will now need to be recommended for use by the Centers for Disease Control and Prevention (CDC) before it can become available to the public.

The first ever vaccine against a common winter virus has been approved by the Food and Drug Administration.

It was not clear whether approval would be extended to children, but there are other RSV vaccines in development for the age group. One being made by Pfizer is expected to be approved later this year.

Developed by British pharmaceutical giant GSK, Arexvy is administered as a single dose to patients to spark protection.

The FDA approval was based on a study of 25,000 patients who received either Arexvy or a placebo.

The study is due to run for three RSV seasons, with the approval based on data from the first year of the study.

It was not clear whether participants may later be offered booster doses.

Side effects of the injection included pain at the injection site, fatigue, muscle pain, headaches and joint stiffness.

Ten vaccine recipients also suffered atrial fibrillation, or an irregular heartbeat.

In two other studies on the vaccine, two participants had brain inflammation and one suffered from Guillain-Barre syndrome, a rare disorder in which the body’s immune system damages cells.

Announcing the approval of the drug Dr Peter Marks, an FDA director, said this was an ‘important public health achievement’.

‘Older adults, in particular those with underlying health conditions such as heart or lung disease or weakened immune systems, are at higher risk for severe disease caused by RSV.

‘Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.’

Leave a Reply

Your email address will not be published. Required fields are marked *