The Food and Drug Administration (FDA) has recently given its approval for the first vaccine designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 and older. RSV is a contagious virus that commonly infects the lungs and breathing passages. According to the Centers for Disease Control and Prevention (CDC), most people with RSV experience mild symptoms resembling a cold, with a recovery time of one to two weeks.
The newly approved vaccine, called Arexvy and developed by GSK, is a single-dose vaccine that is expected to be available to those aged 60 and over by fall. This demographic is at a higher risk of developing severe diseases from RSV. However, the use of the vaccine still needs to be recommended by the CDC’s Advisory Committee on Immunization Practices.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of the vaccine for older adults, particularly those with underlying health conditions such as heart or lung disease or weakened immune systems. According to the CDC, RSV causes around 6,000 to 10,000 deaths among adults aged 65 and older in the U.S. each year. Additionally, RSV is common among children, causing 100 to 300 deaths in children under 5 annually. It is also the leading cause of pneumonia and bronchiolitis in children under 1 year old in the U.S.
The FDA approval of the first RSV vaccine comes after a surge in cases of RSV, COVID-19, and flu towards the end of 2022, which was referred to as a “tripledemic” surge. Marks highlighted the significance of this milestone in public health and the FDA’s commitment to developing safe and effective vaccines for use in the United States.
Clinical trials conducted over the past 60 years have shown that the Arexvy vaccine is 83% effective in preventing lower respiratory tract disease caused by RSV and 94% effective in preventing severe diseases in seniors.
However, it is important to note that there have been rare cases of adverse effects associated with the vaccine. In one study, two participants developed acute disseminated encephalomyelitis (a rare inflammation affecting the brain and spinal cord) after receiving Arexvy alongside the FDA-approved influenza vaccine. Another study reported one participant developing Guillain-Barré syndrome, a rare disorder that damages nerve cells and can lead to muscle weakness and paralysis, after receiving Arexvy.
In response, the FDA is requesting that GSK conduct a postmarketing study to further evaluate the risks of Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM).
Overall, the approval of the first RSV vaccine marks a significant milestone in public health, providing a preventive measure against a potentially life-threatening disease.
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