Arexvy was the first vaccine approved to prevent respiratory syncytial virus (RSV), a common virus that usually causes mild cold-like symptoms. These symptoms can be more severe in babies, older adults, those with compromised immune systems, and those with other health conditions. In some people, rsv can cause lower respiratory tract infections such as pneumonia. According to the CDC, leads to 110,000 to 180,000 hospital stays each year among adults ages 50 and older in the United States. Arexvy has been shown to greatly reduce the risk of severe disease and hospitalization from RSV.
How Does Arexvy Work?
Vaccines help your body learn to fight infections. Arexvy contains proteins from the RSV virus. These virus proteins will not make you sick or give you RSV. When these virus proteins come in contact with your immune system, it quickly makes antibodies. These antibodies remember that virus and will help fight it off if you are exposed to it again.
How Was Arexvy Studied in People 60 or Older?
The effect of Arexvy against RSV-associated lower respiratory tract disease (LRTD) was initially studied in adults ages 60 years and older. In the first study, people were at least 60 years old, with 69 being the average age at the time of vaccination. This study included over 24,000 people. The majority of people were White (79%), and 51% were female. Some of the people (39%) had health conditions that put them at risk for severe disease.
A second study looked at the immune response of the vaccine over two to three years. People in this study were 60 years or older; the average age was 70 when the vaccine was given.
A third study looked at giving the flu vaccine on the same day as Arexvy. Half of the people received both vaccines on the same day, while the other half received the vaccines 1 month apart. The average age of the people in the study was 68 years old, 50% of people were mixed race, and 51% were female.
What Are the Benefits of Arexvy in People 60 or Older?
The main goal of the first study was to see how well Arexvy prevented people ages 60 and older from getting RSV-related lower respiratory tract illness during the first RSV season after receiving the vaccine.
Results showed that the risk of developing RSV-associated LRTD was reduced by 82.6% in people over 60 years old who received Arexvy. Arexvy reduced the risk of severe disease by 94% compared to placebo in people over 60. Arexvy also reduced the risk of RSV-associated LRTD by 94.6% those with coexisting health conditions.
Results are shown in the tables below. Your results may be different than what was seen in the studies.
Overall cases of RSV-related lower respiratory tract disease (LRTD)
Arexvy | Placebo | |
Cases of RSV | 7 | 40 |
Number of people | 12,466 | 12,494 |
Severe cases of RSV-related LRTD
Arexvy | Placebo | |
Cases of severe RSV | 1 | 17 |
Number of people | 12,466 | 12,494 |
Cases of RSV-related LRTD in people with coexisting conditions
Arexvy | Placebo | |
Cases of RSV | 1 | 18 |
Number of people with health conditions of interest | 4,937 | 4,861 |
Health conditions of interest include lung disease, heart disease, liver disease, kidney disease, and diabetes.
A long-term study in adults 60 years and older showed that one dose of Arexvy was about 67% effective at preventing RSV-associated LRTD over two RSV seasons and about 63% effective at preventing RSV-associated LRTD over three RSV seasons. This study showed that the body’s immune response declined 1 year after vaccination but is still better than it was before vaccination. Future study results will help determine if or when a second vaccine should be given.
Another study showed that giving the flu vaccine and Arexvy together did not interfere with the body’s immune response to the vaccine. The Arexvy vaccine may be given on the same day as the flu vaccine. This may help reduce health care visits and ensure that people are protected against infections.
Does Arexvy Work for People Younger than 60?
Two studies were done in people younger than 60 years old at increased risk for LRTD from RSV. One of these studies included people between 50 and 59 while the other included people between 18 and 49 years old. Both studies included people with a higher risk of lower respiratory illness from RSV due to long-term (chronic) health conditions such as lung disease, heart disease, diabetes, or kidney or liver disease.
Researchers compared the immune response of these younger people to the immune responses of people 60 and older. This seemed reasonable since the Arexvy had already been shown to be helpful in that age group. Researchers looked at two things:
- Antibody levels: the amount of antibodies your body makes after getting the vaccine
- Response rates: the percentage of people who had a meaningful immune response
Both studies found that Arexvy led to immune responses that were similar to those seen in adults 60 and older. In other words, the vaccine triggered a similar level of immune protection across all of these age groups. This suggests that Arexvy is likely to be effective in adults between 18 and 59 years old who have chronic medical conditions that could increase their risk for LRTD from RSV.
How Do I Know If It Is Working?
Some people experience fever, muscle aches, and tiredness after getting a vaccine. This is your body responding to the vaccine. If you don’t experience side effects, that does not mean the shot is not working.
While it is still possible to get RSV even though you have been vaccinated, your risk of having severe disease is much lower.
Is Arexvy Right for Me?
Arexvy is FDA-approved for people ages 60 years and older. It is also approved for adults aged 18 to 59 who are at an increased risk of LRTD from RSV. You may be at an increased risk if you have health problems such as COPD, asthma, heart failure, or diabetes.
Arexvy was not studied in people with the following conditions:
- Allergic reactions to vaccine components
- Unstable chronic conditions
- Dementia
- Immunocompromised
- Latex allergy
- Chronic alcohol or substance use disorder
- Pregnancy
Speak with your health care provider or pharmacist for more information and to decide if Arexvy is right for you.
How Do I Manage Arexvy Side Effects?
The most common side effects of Arexvy are pain from the injection, joint pain, muscle pain, tiredness, and headache.
Pain where the needle went in your skin was the most common side effect in studies. If you experience pain, you can apply an ice pack or cool compress to the area. Your health care provider or pharmacist may also recommend an over-the-counter (OTC) pain reliever such as acetaminophen or ibuprofen.
If you experience joint or muscle pain following vaccination, your health care provider may recommend an OTC pain medication such as acetaminophen or ibuprofen. Pain medicine should not be taken before getting the vaccine as this can interfere with how well the vaccine works.
The Arexvy vaccine may make you feel tired. Plan ahead and make sure you have time to rest in the days following the vaccine.
Headaches commonly occur with the Arexvy vaccine. To limit headaches, be sure you are getting enough rest and staying hydrated. Avoid strenuous exercise and avoid foods or drinks that may make headaches worse, such as alcohol. Try to fit in relaxing activities you enjoy, such as reading or listening to music. Your health care provider may recommend an OTC pain reliever as well.
Fainting can occur after getting any vaccination. Fainting can cause you to fall and become injured. You are more likely to feel faint if you are nervous, hungry, or thirsty. You may feel dizzy, lightheaded, weak, nauseous, or sweaty. Make sure you are sitting down while getting the vaccine and for 15 minutes afterward. Tell your health care provider if you suddenly feel sick after getting the vaccine or if you have a history of fainting.
In one study, one case of Guillain-Barre syndrome was found to be related to the vaccine. Symptoms started 9 days after vaccination and the patient recovered 6 months later. Tell your health care provider if you have a history of Guillain-Barre syndrome.
Most vaccination side effects resolve within a few days. This is not a complete list of side effects. If side effects do not go away or are bothersome, tell your healthcare provider.
You can report vaccine side effects to the U.S. Department of Health and Human Services at www.vaers.hhs.gov or by calling 800-822-7967.
How Is It Given?
Arexvy is a single-dose shot that must be given by a health care provider. It is injected into the deltoid muscle in the arm.
RSV usually circulates in the fall and winter months. The best time to get the vaccine is from late summer to early fall. It takes about 2 weeks for the vaccine to take effect.
What Type of Drug Interactions Can Happen?
Some medications can affect the way the vaccine works. Immunosuppressant medications, such as chemotherapy and high-dose steroids, can decrease the effect of the vaccine.
Vaccinations should be given at least 2 weeks before starting immunosuppressant medications, if possible. For those taking high-dose steroids, vaccinations should be given at least 4 weeks before starting or 2 weeks after finishing steroids. In general, the Advisory Committee on Immunization Practices recommends that if you were immunized while taking immunosuppressant medications, you will need another dose at least 3 months after discontinuing the immunosuppressants. Talk to your health care provider about when you should get Arexvy and how many doses you may need.
How Long Does It Stay in Your System?
Vaccines get broken down in the body within a few days to weeks. The protective effects of the vaccines can last for years. Studies are ongoing to determine if or when another dose will be necessary for Arexvy. Current studies show the vaccine is effective at reducing the risk of illness for at least two RSV seasons but the immune response seems to decline over time.
How Can I Get Arexvy?
Most pharmacies offer vaccines. Some states may require a prescription from your health care provider. Contact your pharmacist or health care provider for more information.
Is There Cost Assistance Available?
Eligibility depends on your current prescription insurance coverage. Most insurances cover Arexvy for people over the age of 60. Medicare Part D should cover the RSV vaccine with no out-of-pocket charges. Ask your pharmacist or health care provider if Arexvy will be covered.
For more information, visit GSKforyou.com or call 866-398-0020
