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World’s first respiratory syncytial virus vaccine approved by the Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the world’s first respiratory syncytial virus (RSV) vaccine, called Arexvy, developed by pharmaceutical company GSK. The vaccine is a single-dose shot, designed to protect patients aged 60 and older from lower respiratory tract diseases caused by RSV. According to the New York Post, it took 60 years to develop this breakthrough vaccine.

The CDC states that RSV, which typically causes mild, cold-like symptoms, can lead to severe illness in older people and young children. The virus is highly contagious and is responsible for over 60,000 hospital admissions and 6,000 or more fatalities among US citizens aged 65 and over, as well as 100 to 300 deaths among children under the age of five each year. Additionally, the CDC forecasts that up to 80,000 children under five will be hospitalized each year due to RSV.

Data from a clinical trial involving 12,500 individuals receiving Arexvy and an equal number receiving a placebo were reviewed by the FDA, which reports that immunization with Arexvy reduced the probability of severe RSV-associated LRTD by 94% and RSV-associated LRTD by 83%. The most common side effects of the vaccine are soreness at the injection site, fatigue, muscle pain, headaches, and joint stiffness.

GSK has promised to make the vaccine available to seniors before the RSV season, which is expected to begin in the fall. The American Medical Group Association’s President, Dr. John Kennedy, states that this vaccine will help protect those over the age of 60 and those with underlying health conditions like COPD, asthma, or congestive heart failure from serious RSV outcomes.

Although researchers had expected that Pfizer’s RSVpreF vaccine would be the first RSV vaccine approved by the FDA, they believe it is still likely to gain approval. The vaccine, the first RSV vaccine for expectant mothers, may be given to women in their late second or third trimesters, and its approval is expected in August.


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