Abrysvo
Pronunciation: uh-breez-voh
Generic name: respiratory syncytial virus vaccine (RSVpreF)
Dosage form: vial for reconstitution, prefilled syringe
Drug class: Viral vaccines
What is Abrysvo?
Abrysvo vaccine protects against LRTD (lower respiratory tract disease) caused by the Respiratory Syncytial virus (RSV) in adults aged aged 18 and older with conditions that put them at high risk of LRTD, and all adults aged 60 years and older. Abrysvo is also given to pregnant women from 32 weeks through 36 weeks of pregnancy to protect their babies once they are born from RSV. Abrysvo is a Respiratory Syncytial Virus (RSV) vaccine.
- By vaccinating the mother, Abrysvo protects against LRTD in infants from birth through 6 months of age. Abrysvo is the only RSV vaccine approved for use during pregnancy (see What is the difference between Arexvy and Abrysvo?).
- RSV season is considered to be September to January. Abrysvo may be given at any time of the year, but where possible, should be offered before the start of the RSV season.
- Abrysvo is not an annual vaccine and only one dose of Abrysvo is needed. Abrysvo is not given every RSV season.
Vaccination with Abrysvo may not protect everybody who receives it.
Abrysvo vaccine first received FDA approval on May 31, 2023, for adults aged 60 and older. This approval was extended on August 21, 2023, to include pregnant women from 32 through 36 weeks gestation, and further extended to include adults aged 18 through 59 years at higher risk of LRTD on October 22, 2024.
Abrysvo uses
Abrysvo is used to prevent LRTD caused by RSV in adults 18 years of age and older at high risk of LRTD and all adults aged 60 and older.
Abrysvo vaccine is also used to vaccinate pregnant women who are 32 through 36 weeks pregnant to prevent LRTD caused by RSV in infants from birth through 6 months of age.
Abrysvo and pregnancy
Abrysvo is currently the only RSV vaccine approved for use during pregnancy to protect infants from RSV-associated LRTD.
- The recommended administration window of Abrysvo in pregnancy is between 32 weeks 0 days and 36 weeks 6 days of pregnancy.
- For most areas in the continental United States, the vaccine should be given from September through January.
When Abrysvo is given to pregnant women it provides passive immunity to their infants against RSV. Abrysvo does this by stimulating the production of antibodies in the mother, which are then transferred to the unborn baby through the placenta.
Beyfortus is a different RSV vaccine that can protect infants against RSV once they have been born.
- Beyfortus is administered directly to the infant and is FDA-approved for newborns and babies under 1 year of age to protect them from LRTD caused by RSV.
- Beyfortus is an injectable preventive antibody that provides passive immunization and immediate and short-term protection against RSV that generally lasts around 5 months.
- Beyfortus may also be given to children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.
Most infants will only need protection from only one of these products, either Abrysvo or Beyfortus, not both.
Abrysvo side effects
The most common side effects of Abrysvo are:
- pain at the injection site
- headache
- muscle pain
- nausea
- fatigue.
Serious side effects and warnings
Abrysvo may cause the following serious side effects.
Potential risk of preterm birth. Abrysvo may increase the risk of having your baby too early (preterm). To lessen this potential risk, Abrysvo should not be administered to pregnant women before 32 weeks of gestation. It should only be administered from 32 weeks through 36 weeks gestational age.
Allergic reactions. Vaccinations may cause allergic reactions, including anaphylaxis, in some people. These usually happen within the first few minutes after an injection. Abrysvo vaccine should be administered in a facility that can provide the appropriate medical treatment and supervision to manage possible anaphylactic reactions following administration. Tell your healthcare provider if you have ever reacted to a vaccine. See urgent medical attention if you develop facial or throat swelling, a dry cough, a rash, or difficulty breathing.
Fainting may occur following the administration of vaccines, such as Abrysvo vaccine. Sit or lie down during the vaccination to avoid injury from fainting.
People who are immunocompromised, including those receiving immunosuppressive therapy, may have a diminished immune response to vaccines.
Related/similar drugs
Arexvy
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Beyfortus
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Before receiving
Do not administer Abrysvo vaccine to anyone with a known history of severe allergic reactions (such as anaphylaxis) to Abrysvo or any of its inactive ingredients.
Abrysvo is not approved for children.
Before receiving Abrysvo tell your healthcare provider about all your medical conditions, including if you:
- have bleeding or bruising problems
- are prone to fainting after a vaccination
- are younger than 18 years or not pregnant
- are pregnant or intending to become pregnant
- are breastfeeding.
How is Abrysvo administered?
Abrysvo is given by intramuscular injection, usually into the deltoid muscle of the upper arm.
- One dose is given.
- Abrysvo is given to pregnant women from 32 weeks through 36 weeks gestation during the RSV season (September to January).
- The CDC recommends Abrysvo as a single dose for all adults aged 60 and older and adults aged 18 and older with long-term health conditions, such as asthma, COPD, heart disease, or severe diabetes, that put them at risk of severe RSV disease.
Abrysvo vaccine dosage
Abrysvo Act-O-Vial dosage for adults 18 and older and pregnant women: Abrysvo 0.5 mL (after reconstitution)
Abrysvo vial and prefilled syringe dosage for adults 18 and older and pregnant women: Abrysvo 0.5 mL.
Storage
Your healthcare provider will store Abrysvo refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Abrysvo should not be frozen. Discard if the carton has been frozen.
After reconstitution, your healthcare provider will administer Abrysvo immediately or store it at room temperature [15ºC to 30ºC (59ºF to 86ºF)] and use it within 4 hours. Discard if the carton has been frozen.
Abrysvo ingredients
Active ingredients: 120 mcg of RSV stabilized perfusion F proteins (60 mcg RSV preF A and 60 mcg RSV preF B) per 0.5 mL.
Inactive ingredients: 0.11 mg tromethamine, 1.04 mg tromethamine hydrochloride, 11.3 mg sucrose, 22.5 mg mannitol, 0.08 mg polysorbate 80, and 1.1 mg sodium chloride per 0.5 mL.
Contains no preservatives.
The Act-O-Vial stoppers, vial stoppers and tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.
Who makes Abrysvo?
Pfizer Inc. makes Abrysvo.
Abrysvo Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Abrysvo.
Abrysvo (Respiratory Syncytial Virus Vaccine) - Pfizer Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 120 mcg |
Popular FAQ
What is the difference between Arexvy and Abrysvo?
Arexvy and Abrysvo are both RSV vaccines that are approved for use in adults over the age of 60 to reduce their risk of developing lower respiratory tract disease (LRTD). They are also approved for adults aged 50 through 59 years (Arexvy) or aged 18 through 59 (Abrysvo) with certain chronic medical conditions (such as chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney or liver disease) that put them at increased risk of LRTD caused by RSV. Abrysvo is also approved for use in pregnant women between 32 through 36 weeks gestation, to protect infants against LRTD from the moment they are born until they are 6 months of age. Arexvy is made by GSK and was approved on May 3, 2023; the first RSV vaccine to be approved for older adults. Abrysvo is made by Pfizer and was approved on May 31, 2023; the second RSV vaccine to be approved for older adults. Continue reading
What are the symptoms of respiratory syncytial virus (RSV)?
RSV symptoms are runny nose, sore throat, stuffy nose, cough wheezing, headache, and fever for adults and RSV symptoms in the young include decreased activity, irritability, and breathing difficulties. Continue reading
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.