The Food and Drug Administration World’s first approved vaccine against respiratory syncytial virus (RSV)This is what researchers have been working on for decades after devastating clinical trials in the 1960s.
The vaccine, called Arexvy from pharmaceutical giant GSK, is approved for adults 60 and older. The Centers for Disease Control and Prevention should recommend vaccines before they are available. The FDA’s Advisory Committee on Immunizations will next meet on June 21-22, when vaccines can be discussed.
RSV is a common and highly contagious seasonal respiratory infection. It is often associated with infants who are at particularly high risk of developing severe disease. In fact, bronchitis due to RSV infection is Major Causes of Infant Hospitalization Under 1 year old in the US.but the virus Dangerous for the elderlyIt causes an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths in the elderly each year.
In an ongoing randomized, placebo-controlled clinical study in adults aged 60 years and older, approximately 12,500 participants received Arexvy and 12,500 participants received a placebo. The vaccine reduced the risk of developing lower respiratory tract infections from RSV by 82.6%. and he reduced her risk of developing a severe RSV infection by 94.1%, the FDA notes.
“Older people, especially those with underlying medical conditions such as heart or lung disease or a weakened immune system, are at increased risk of serious illness from RSV,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. said Mr. Wednesday’s approval of this first of his RSV vaccine “is an important public health achievement to prevent a potentially life-threatening disease,” he added.
triumph after tragedy
GSK also celebrated GSK Chief Scientific Officer Tony Wood said the approval “marks a tipping point in our efforts to reduce the significant burden on RSV.”
GSK’s vaccine is just the first of several RSV vaccines in development. Pfizer has his RSV vaccine for adults over 60. Nearly 86% effective For severe disease in a phase III trial. It is currently undergoing FDA review and is expected to be approved later this month. Moderna announced in January that his RSV vaccine for the elderly was 82% effective against severe illness.
Pfizer also has a vaccine to protect babies nearing regulatory decisions. When a pregnant participant was vaccinated in a phase III trial, she was 82% effective in preventing severe RSV in her first 3 months of infancy, compared to her first 6 months. It was 69% effective in the month.
The vaccine is a triumph after researchers spent decades trying to find a safe and effective design for vaccination. A child was born with more severe RSV than the child. Two of her vaccinated children died after infection.
Subsequent studies showed that these early doomed vaccines presented a key protein, the F protein, in the wrong conformation, stimulating the immune system to produce ineffective antibodies and exaggerating the inflammatory response. shown to exacerbate the disease. It wasn’t until decades later that researchers at the National Institutes of Health discovered how to lock his F protein into a conformation that elicited an effective immune response, paving the way for current vaccine design. That was it.
