The U.S. Food and Drug Administration (FDA) has approved Arexvy, the world’s first vaccine against respiratory syncytial virus (RSV). This marks a significant scientific breakthrough in the 60-year history of pharmaceutical giant GSK.
Manufactured by GSK, this single-dose injection is designed to prevent lower respiratory tract disease caused by RSV in individuals aged 60 and older.
Tony Wood, GSK’s Chief Scientific Officer, stated in a press release: “Our focus now is to ensure that eligible older adults in the U.S. can access the vaccine as quickly as possible and to conduct regulatory assessments in other countries.”
If approved, RSVpreF will help protect newborns from the devastating effects of this infectious disease right from their first breath.
RSV typically causes mild, cold-like symptoms but can lead to severe illness in the elderly and infants.
Each year, this highly contagious virus is responsible for over 60,000 hospitalizations and more than 6,000 deaths among American adults aged 65 and older, as well as 100 to 300 deaths in children under 5 years old, according to the Centers for Disease Control and Prevention (CDC).
The CDC also estimates that up to 80,000 children under 5 in the U.S. are hospitalized each year due to RSV.
Dr. John Kennedy, President of the American Health Care Association, remarked: “With this vaccine, Americans over 60, especially those with underlying conditions such as COPD, asthma, or congestive heart failure, will be vaccinated to help protect against the serious consequences that can arise from RSV.”
According to the FDA, this vaccine reduces the risk of developing RSV-related lower respiratory tract disease (LRTD) by 83% and the risk of developing severe RSV-related LRTD by 94%.
The most commonly reported side effects of the vaccine include injection site pain, fatigue, muscle pain, headache, and joint stiffness.
GSK has pledged to make the vaccine available to older adults ahead of the RSV outbreak season, which is expected to begin this fall.
Tony Wood, GSK’s Chief Scientific Officer, added: “Arexvy is the first RSV vaccine approved for older adults, expanding GSK’s leading vaccine portfolio and helping to protect millions from infectious diseases each year.”
GSK to Continue Monitoring Vaccine Recipients for Neurological Disorders
The FDA has noted that it is requiring GSK to continue monitoring vaccine recipients for Guillain-Barré syndrome, a rare neurological disorder that can lead to paralysis and acute disseminated encephalomyelitis (ADEM), a rare inflammatory condition affecting the brain and spinal cord.
Clinical trials for the RSV vaccine began in the U.S. in the mid-1960s. The FDA is expected to formally approve the RSV vaccine in August, which will allow vaccination for pregnant women.
“If approved, RSVpreF will help protect newborns from the devastating impacts of this infectious disease right from their first breath,” said Annaliesa Anderson, Chief Scientific Officer for Vaccine Research at Pfizer, in a statement.
This vaccine is said to be 82% effective in preventing severe illness in newborns during their first 90 days of life and 70% effective in reducing RSV-related hospitalizations in infants up to 6 months old.
Last year, U.S. doctors reported a record number of RSV cases, with pediatric emergency departments in New York City experiencing significant surges.
