Key takeaways:
Arexvy is the first FDA-approved respiratory syncytial virus (RSV) vaccine. It can help lower the risk of developing serious respiratory illness from the infection in adults ages 60 and older.
Injection site pain, headache, and muscle or joint pain are commonly reported Arexvy side effects. While rare, more serious side effects, like abnormal heart rhythms have also been reported.
A CDC expert panel is meeting in June to provide its recommendations for how to use Arexvy. The vaccine is expected to be available before RSV season later this year.
When you think of respiratory syncytial virus (RSV), infants and young children likely come to mind. After all, most children get their first RSV infection within their first 2 years of life. But adults can get RSV, too. And for some, the infection can lead to serious illness — or even death.
Prior attempts to develop a safe and effective RSV vaccine had been unsuccessful. But decades later, recent discoveries have made one a reality. In May 2023, the FDA approved Arexvy, the first RSV vaccine. It can be given to adults ages 60 and older.
Will you be eligible for Arexvy once it’s available? If so, there’s a few things you should know about the first RSV vaccine.
The FDA approved Arexvy for adults ages 60 and older after reviewing findings from four phase 3 clinical trials. These trials included nearly 16,000 adults in this age group who received the vaccine. But why was Arexvy studied in older adults specifically?
Many adults with an RSV infection only experience cold-like symptoms. And, in some cases, you may not even realize you have RSV. But as you get older, your immune system may not fight off infections as well. And having other health conditions can complicate getting sick even more.
For some older adults, an RSV infection can result in serious lung infections that require hospitalization. In fact, it’s estimated that up to 160,000 older adults are hospitalized for this reason every year, and up to 10,000 die. An RSV vaccine for this age group is expected to decrease these numbers significantly.
In the 1960s, an RSV vaccine was tested in babies. The shot contained an inactivated (killed) version of RSV. However, the vaccine failed to protect against RSV. And many children who received it ended up having worse RSV infections after they were exposed to the virus.
Today, researchers have a better understanding of RSV. Arexvy, along with most other RSV vaccines in late-stage clinical trials, work by targeting a specific form of the F protein called preF. RSV normally uses this protein to latch onto and infect your cells.
Arexvy contains the preF protein, which is then mixed with an adjuvant. An adjuvant is a substance that helps your immune system respond to the vaccine better.
After you receive your Arexvy dose, your immune system is alerted, as preF is seen as a foreign invader. As part of this response, your body makes antibodies and other memory cells to remember it. This helps your immune system recognize and fight RSV faster and better if you’re exposed to it in the future.
An RSV infection can result in a serious lower respiratory tract disease (LRTD), including pneumonia. Arexvy has been shown to help prevent LRTD from RSV in older adults. In fact, this was how researchers determined if the vaccine was effective during clinical trials.
Compared to people who didn’t get the vaccine, those who received Arexvy had a significantly lower risk of LRTD from RSV. The vaccine was nearly 83% effective against LRTD, and 94% effective against severe LRTD.
Does this mean you can still get RSV after you’ve been vaccinated? The short answer: Yes. But you may be less likely to end up getting seriously sick.
Your age and certain health conditions can increase your risk of LRTD from an RSV infection. And if you’re planning to be around small children at an event or over the holidays, you may be more likely to get exposed to RSV. Getting vaccinated is one of the best ways to protect yourself.
As with most vaccines, you may experience temporary side effects after receiving a dose. During clinical trials, adults receiving Arexvy experienced side effects that included:
Injection site pain
Muscle pain
Fatigue
Headache
Joint stiffness or pain
A small number of people receiving the RSV vaccine experienced atrial fibrillation, a type of abnormal heart rhythm, within 30 days of receiving their dose. This also happened in a few people who didn’t receive the vaccine.
During clinical trials, there were also reports of a rare type of brain and spinal cord inflammation. This happened to two people who received the RSV and flu vaccines together. There was also one instance of Guillain-Barré syndrome — a condition where your immune system attacks your nerves.
It’s not clear if these more serious side effects are linked to Arexvy specifically. But once the vaccine is available, Arexvy’s manufacturer will be monitoring for any other reports.
People ages 60 or older may be eligible to receive the RSV vaccine once it’s available. This should happen just in time before the winter months — when RSV and other seasonal infections, like the flu, hit many areas of the U.S. Its specific launch date hasn’t been announced.
In June 2023, a CDC expert panel will meet to make recommendations for how Arexvy should be used. This may include who should receive it, and if it’s safe to combine with other vaccines. The CDC is in charge of making vaccine recommendations for U.S. kids and adults.
Possibly. One clinical trial studied the effects of receiving Arexvy and the Fluarix Quadrivalent flu shot at the same time. People who received the RSV and flu vaccines together had just as good of an immune response to both vaccines. This was compared to those who received the shots 30 days apart. Safety was also comparable between groups.
In other words, getting the RSV vaccine and flu shot at the same time doesn’t seem to interfere with how well they work. As mentioned above, additional guidance from the CDC may be available on this topic soon.
Arexvy is the first FDA-approved RSV vaccine available in the U.S. For older adults ages 60 and older, Arexvy can significantly lower the chance of serious respiratory illness from the infection. This vaccine is expected to reduce hospitalizations and death from RSV in this age group.
Still on the fence about getting vaccinated against RSV? It’s worth having a discussion with your healthcare provider about the potential benefits and risks for you.
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Kim, H. W., et al. RESPIRATORY SYNCYTIAL VIRUS DISEASE IN INFANTS DESPITE PRIOR ADMINISTRATION OF ANTIGENIC INACTIVATED VACCINE. American Journal of Epidemiology.
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