Arexvy was the first vaccine approved to prevent respiratory syncytial virus (RSV). RSV is 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, RSV causes between 6,000 to 10,000 deaths each year in older adults. Arexvy has been shown to greatly reduce the risk of severe disease and hospitalization from RSV.
How Does It 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 It Studied?
The effect of Arexvy against RSV-associated lower respiratory tract disease (LRTD) was studied. People in this study were at least 60 years old, with 69 being the average age. The majority of people were White (79%), and 51% were female. Thirty-nine percent of people had health conditions that put them at risk for severe disease. This study included over 24,000 people.
A second study looked at the immune response of the vaccine. The study is ongoing as of 2024 and will evaluate results after 3 years. People in this study were over the age of 60, with the average age being 70.
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?
Results showed that the risk of developing RSV-associated LRTD was reduced by 82.6% in people over 60 years old who took Arexvy. Arexvy reduced the risk of severe disease by 94% compared to placebo in people over 60. Arexvy has also shown to be 94.6% effective against
RSV in 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
Arexvy | Placebo | |
Cases of RSV | 7 | 40 |
Number of people | 12,466 | 12,494 |
Severe cases of RSV
Arexvy | Placebo | |
Cases of severe RSV | 1 | 17 |
Number of people | 12,466 | 12,494 |
Cases of RSV in high-risk people
Arexvy | Placebo | |
Cases of RSV | 3 | 17 |
Number of people who are high risk | 4,231 | 4,127 |
Patients were classified as high risk if they had coexisting health conditions that put them at risk for more severe disease.
Cases of RSV 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.
An extension study showed that one dose of Arexvy was 67% effective at preventing RSV-associated LRTD over two seasons.
The second study has shown that the body’s immune response declined 1 year after vaccination but is still better than before vaccination. Future results will help determine 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.
How Long Until You Get the Full Effects?
It takes about 2 weeks for your body to produce a response to the vaccine. Protection from the Arexvy vaccine is expected to last for two RSV seasons.
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 It Right for Me?
Arexvy is recommended for people over 60 years old. It is also recommended by the FDA for those aged 50 to 59 who are at an increased risk of LRTD from RSV. You may be at an increased risk if you have COPD, asthma, heart failure, or diabetes. Speak with your health care provider or pharmacist for more information.
Arexvy was not studied in people with the following conditions:
- Allergic reactions to vaccine components
- Serious or unstable chronic conditions
- Dementia
- Neurological or seizure disorder
- Immunocompromised
- Latex allergy
- Chronic alcohol or drug misuse
- Pregnancy
How Do I Manage 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. No other cases of Guillain-Barre have occurred since. 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 positive effects of the vaccines can last for years. Studies are looking at exactly when another dose will be necessary for Arexvy. Current studies show the vaccine is effective for at least two RSV seasons.
What Do I Need to Do to Get It?
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-GSK-FOR-U.
