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, was approved by the US on Wednesday.
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 truly requires RSV protection or just those who are 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 is also requesting permission to immunize expectant mothers so that the babies are born with part of the mother’s protection.
There is currently no RSV vaccination for children, but during the RSV season, high-risk newborns frequently receive monthly doses of a protective medication, and European regulators just approved the first one-dose option. The FDA is also debating whether to approve the one-shot medication developed by Sanofi and AstraZeneca.
“This is a very exciting time with multiple potential RSV solutions coming out after years of really nothing,” said Dr. Phil Dormitzer, director of vaccine research and development at GSK, formerly known as GlaxoSmithKline.
For the majority of people, RSV is a minor inconvenience similar to a cold, but it can be fatal for the very young, the elderly, and those with certain high-risk medical conditions. It can obstruct babies’ breathing by inflaming their small airways, or it can get deep inside the lungs of elderly people and cause pneumonia.
Each year, RSV causes roughly 58,000 children under the age of five to be hospitalized, and several hundred of them pass away. Up to 177,000 older persons may require hospitalization for RSV each year, and 14,000 may pass afterwards.
Why has developing a vaccine taken so long? When an experimental shot made child infections worse 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.
One dosage of the vaccine was about 83% effective at preventing RSV lung infections in a global study of roughly 25,000 adults aged 60 and over, and it lowered the chance of severe infections by 94%.
GSK is following trial participants for three years while comparing those who had just one immunization during that time to those who received a yearly booster in order to determine how long protection lasts. Shot side effects included weariness and muscle aches, which are typical of immunizations.
One case of Guillain-Barre syndrome, which can cause generally transient paralysis, and two cases of a form of inflammation of the brain and spinal cord provided an indication of an uncommon but substantial risk. The FDA declared that it was required the business to keep researching whether there is in fact a connection to the vaccine.
They will receive a second dose for the fall in addition to their annual flu shot, and maybe another COVID-19 booster, if the CDC finally advises vaccination for some or even all seniors.
According to Schaffner, an infectious disease specialist at Vanderbilt University, “We’ll have to educate the population that this virus, which not everyone has heard of, is actually an important threat to their health in the winter.”
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