The U.S. Food and Drug Administration approved the world’s first vaccine to prevent the respiratory infection RSV, short for respiratory syncytial virus, on May 3, 2023. The new shot represents six decades of starts and stops in the hunt for a vaccine to curb one of the most common winter respiratory viruses. RSV leads to around 14,000 deaths in older adults every year and can cause severe illness in infants and children as well.
The vaccine, called Arexvy, made by the biopharmaceutical company GSK, is approved for use in adults ages 60 and over. Now that it is FDA-approved, it must still be endorsed by the Centers for Disease Control and Prevention, a move that’s expected in summer 2023.
The Conversation asked Annette Regan, an epidemiologist and vaccine specialist, to discuss the significance of the first vaccine against RSV and the other RSV vaccine candidates that are in the pipeline.
The vaccine targets a protein known as RSV F glycoprotein, which is found on the surface of the virus. The F protein enables the RSV virus to enter host cells.
By stimulating antibodies against this protein, the vaccine should protect against infection. Clinical trial data suggests this is the case, since Arexvy was 80% effective at protecting against RSV-related disease and 94% effective at protecting against severe disease.
The vaccine also includes an adjuvant, a substance that helps amplify the effect of the vaccine by boosting the immune system’s response.
The RSV vaccine has been developed for and tested in adults age 60 and older. While the FDA has approved the vaccine – which means it has deemed it safe and effective – the shot will not be administered by health care professionals until it is reviewed by an independent expert group coordinated by the CDC called the Advisory Committee on Immunization Practice, which makes vaccine recommendations to the CDC.
The committee’s recommendations will cover how the vaccine should be used – including the ages at which the vaccine should be given – the number of doses needed, the time between doses and precautions and contraindications.
The committee is expected to meet in June 2023 to make a recommendation on the new RSV vaccine, after which the CDC would officially endorse it. The vaccine could be rolled out to the public as soon as late summer 2023, well before the typical RSV season, which usually starts in the fall and peaks in winter.
It’s hard to say what the committee’s recommendation will be. It could recommend the vaccine for all adults 60 and older, or a subset of older adults. While the clinical trial showed the vaccine was 81% effective among adults ages 60 to 69 and 94% effective among adults ages 70 to 79, it was only 34% effective among adults 80 and older. Given the lower efficacy for adults ages 80 and older, the committee could place an age cap on the recommendations.
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