The US supported the first RSV vaccine, shots to protect older adults against a respiratory virus that is best famous for harming babies but also puts their grandparents at risk.
Following the Food and Drug Administration’s ruling, GSK’s shot, known as Arexvy, becomes the first RSV vaccine in the pipeline to receive global licensing.
The decision sets the ground for those 60 and older to receive the RSV vaccine this autumn. However, the Centers for Disease Control and Prevention must first determine whether every senior indeed requires RSV protection or just those thought to be at high risk for contracting the virus.
In June, the CDC’s advisors will discuss this issue.
Doctors are eager to finally have something to provide after decades of failure in the search for an RSV vaccine, especially in the wake of a virus surge that stressed hospitals last fall.
According to Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who wasn’t involved in its research, “This is a great first step… to protect older persons from serious RSV disease.”
For what is anticipated to be a series of new protections, “we’re going to be working our way down the age ladder” next.
The FDA is examining a comparable vaccination for senior citizens from rival Pfizer. Pfizer also requests permission to immunize expectant mothers so that the babies are born with part of the mother’s protection.
Although there is currently no RSV vaccine for children, high-risk infants receive monthly doses of a protective medication during the RSV season, and European regulators recently approved the first one-dose option.
The one-shot drug developed by Sanofi and AstraZeneca is also up for FDA approval.
“This is a fascinating time with multiple potential RSV solutions coming out after years of really nothing,” said Dr. Phil Dormitzer, director of vaccine research and development for GSK, formerly GlaxoSmithKline.
RSV is a cold-like annoyance for most individuals, but it can be fatal for the very young, the elderly, and those with certain high-risk medical conditions.
It can make it difficult for babies to breathe by inflaming their small airways, or it can get deep inside the lungs of older adults and result in pneumonia.
Each year, RSV causes roughly 58,000 children under five to be hospitalized, and several hundred pass away. Up to 177,000 older persons may require hospitalization for RSV each year, and 14,000 may pass afterward.
Why has developing a vaccine taken so long? When an experimental shot worsened child infections in the 1960s, the field experienced a significant setback.
The development of these vaccinations was finally improved by science, albeit adult volunteers were still used to test the modern candidates.
The new vaccination from GSK for senior citizens teaches the immune system to recognize a protein on the surface of RSV and includes an adjuvant to help amplify that immunological response.
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