On May 3, the U.S. Food and Drug Administration approved a vaccine manufactured by GlaxoSmithKline to prevent respiratory syncytial virus, or RSV, in older adults.
In clinical trials, the vaccine, called Arexvy, was 83% effective at preventing lower respiratory tract disease in older adults and 94% effective at preventing severe disease. The drug maker expects to have vaccine available before the 2023-2024 virus season.
Infectious disease epidemiologist Dr. Cindy Prins, a clinical associate professor at the University of Florida College of Public Health and Health Professions Department of Epidemiology (part of UF Health, the university’s academic health center) and a member of UF’s Emerging Pathogens Institute, answers some common questions about RSV and the new vaccine.
Question: What is RSV and how can it affect older adults?
Answer: RSV is a respiratory virus that may cause cold-like symptoms in healthy adults and older children. But in infants, very young children and older adults, it can sometimes cause more serious disease leading to pneumonia and other infections, hospitalizations and even death. RSV infection can be very severe for older adults and younger children. We have recognized the problem of RSV in young children for a while now, but there has been less awareness of the effect it can have on older adults. Some adults who have contracted RSV have thought it was a bad cold or influenza-like illness, but it hasn’t necessarily been identified as RSV. Because of this, the number of RSV cases in older adults likely is undercounted. You may have heard people talking last fall about a tripledemic. This referred to a huge increase in RSV cases that we saw at the same time COVID and flu cases were rising.
Q: What is the significance of the FDA’s decision?
A: RSV represents a significant burden of disease among older adults. Annually, there are an estimated 60,000 to 160,000 hospitalizations of older adults with RSV and 10,000 deaths. To finally have a vaccine to prevent RSV literally is going to be lifesaving for a lot of people.
Q: What are the vaccine’s side effects?
A: The side effects of the vaccines in the study population mostly were typical and expected. Some participants reported pain, redness and swelling at the injection site. Temporary fatigue, muscle aches and headache also were reported by people who got the vaccine. For most people, the side effects did not prevent their normal everyday activities. There was one case of a neurological disorder called Guillain-Barré syndrome that occurred in people who received the RSV vaccine during clinical trials. While this is a rare occurrence and has happened with other vaccines, it is something that the FDA has asked the company to study further.
Q: What about RSV in young children?
A: Between 60,000 and 80,000 kids younger than 5 years old are hospitalized every year due to RSV. Now we don’t have an RSV vaccine approved for children yet, but the vaccine being available for older adults may help protect young children too. Think about grandparents interacting with their grandchildren, especially with newborns. Everyone wants to pass around the baby. If grandparents have had an RSV vaccination it may actually help to prevent some young children from being exposed to RSV, or lessen the severity of their infection.
Q: Who should get the RSV vaccine?
A: Anyone 65 and older with any kind of lung disease, heart disease or other underlying conditions that may cause them to have problems when they get an infection should consider getting the RSV vaccine. These are the same folks who are considered at high risk if they contract the flu or COVID. The technology used to create the RSV vaccine is not new or out of the ordinary. The vaccine is designed to introduce an RSV protein in a form that allows the body’s immune system to recognize the virus and build antibodies to fight a future infection. I encourage people who want to learn more about the vaccine to seek out reliable sources of information, such as the U.S. Centers for Disease Control and Prevention, and of course, to consult with their physician.