GSK's RSV Vaccine Arexvy Receives FDA Approval for Expanded Use in Adults Aged 50-59 at High Risk
GSK
Pharmaceutical R&D Manufacturer
✎GSK RSV Vaccine Receives FDA Approval
Expand the applicable population to 50-59 years old
On June 7, GSK announced that the FDA approved the expanded use of the recombinant Respiratory Syncytial Virus (RSV) vaccine Arexvy to include high-risk adults aged 50-59, making it the first RSV vaccine available to protect high-risk individuals in this age group.
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GSK to Expand Arexvy Vaccine Trial Population
Arexvy was approved for marketing in the United States and Europe in 2023 successively, used to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and above. It became the world's first approved RSV vaccine in May of the previous year.Data shows the vaccine is 82.6% effective in preventing RSV-related LRTD in the elderly.Last year, about 22% of American adults aged 60 and above received the RSV vaccine.
GSK says it will continue to try to expand the coverage of Arexvy:Currently under study is the injection for people aged 18 and above with increased RSV risk.- Including immunocompromised individuals who have undergone solid organ transplants and those with any underlying comorbidities approved today. Data for these populations is expected to be available in the second half of 2024, at which time the company will follow up with the FDA.
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Current Status of the Respiratory Syncytial Virus Vaccine Development Track
As of now, globally, the RSV vaccines that have been approved besides GSK's Arexvy includePfizerThe bivalent RSV vaccine ABRYSVO andModernaThe company's mRNA RSV vaccine — mRESVIA (mRNA-1345),Both are used to prevent lower respiratory tract diseases caused by RSV in people aged 60 and above.。
In addition, in November 2022,AstraZenecaAndSanofiBeyfortus (nirsevimab), jointly developed, has been approved for marketing by the European Commission, becomingThe world's first and only one that can be widely appliedRSV Prevention Drugs for Newborns and Infants. In January this year, the product has been approved for marketing by the National Medical Products Administration.
At this stage, multiple companies in China are laying out the RSV vaccine track, including Aikang Bio, Advaccine, Zhifei Biological, Walvax Bio/Bluebird Bio, CSPC Pharmaceutical Group, and Shenzhen Bio among others, all advancing RSV-related therapies.
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How Much Do You Know About Respiratory Syncytial Virus?
Respiratory Syncytial Virus (hereinafter referred to as "RSV") is a common respiratory virus. Due to the fusion of infected cells into large cell structures resembling "syncytia," it has been vividly named the respiratory "syncytial" virus.
RSV is an RNA virus that spreads through droplets and close contact, with infected patients mostly exhibiting upper respiratory symptoms.It can occur at any age, primarily in infants and toddlers under 2 years old, followed by older children. Adults with weakened or defective immune systems may also develop complications.
Image source: News screenshot
After RSV infection,The incubation period is usually 2-8 days.The clinical manifestations are mainly symptoms of respiratory tract infection. In the early stage, most RSV infections are limited to the upper respiratory tract, with clinical manifestations such as nasal congestion, runny nose, cough, and hoarseness.
If upper respiratory tract infection symptoms such as nasal congestion, runny nose, cough, hoarseness, sore throat, or throat itching occur during the prevalence of respiratory syncytial virus or after close contact with infected individuals, medical attention should be sought promptly.
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