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Abrysvo

Generic name: Respiratory Syncytial Virus Vaccine
Dosage form: powder for reconstitution
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 22, 2023.

What is Abrysvo?

Abrysvo is an RSV vaccine that is used to immunize pregnant women and adults aged 60 years and older. Abrysvo protects against developing lower respiratory tract disease (LRTD) caused by the respiratory syncytial virus (RSV) for the adults treated, and by vaccinating pregnant women, it protects infants against LRTD from birth through 6 months of age. Abrysvo works by developing immunity against two RSV proteins (antigens) RSVpreF A and RSVpreF B, so that if you get RSV, the infant or adult's immune system will be able to recognize it and destroy it.

RSV is a common, contagious virus that can cause hospitalization and death in patients that are at high risk for severe disease, which includes infants and older adults with underlying medical conditions such as diabetes and chronic heart and lung diseases.

Abrysvo became FDA-approved for adults aged 60 years and older on May 31, 2023. Abrysvo became the first RSV vaccine to be FDA-approved for pregnant women on August 21, 2023. It can be used between 32 through 36 weeks gestational age of pregnancy. It was approved for pregnant women after positive results from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy).

How well does Abrysvo work?

When used in pregnant women, Abrysvo reduced the risk of severe lower respiratory tract disease in infants by 81.8% within 90 days after birth and 69.4% within 180 days after birth. In older adults, the vaccine showed 67% efficacy in reducing the risk of developing RSV-associated lower respiratory tract disease with 2 or more symptoms and 86% efficacy in reducing the risk of developing RSV-associated LRTD in those with 3 or more symptoms.

What are the side effects of Abrysvo?

Abrysvo is generally well tolerated, and the most common side effects included fatigue, headache, injection site pain, and muscle pain. These were generally only short-lived.

Abrysvo side effects (more detail)

Who should not receive Abrysvo?

Do not administer the vaccine to anyone with a known history of severe allergic reactions (such as anaphylaxis) to Abrysvo or any of its components.

Abrysvo pregnancy and breastfeeding warnings (more detail)

Warnings

Possible anaphylactic reactions

Administer in a facility that can provide the appropriate medical treatment and supervision to manage possible anaphylactic reactions following administration.

For pregnant individuals

To avoid the potential risks of preterm birth, vaccination should be given during 32 through 36 weeks of gestational age.

In clinical trials where Abrysvo was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% Abrysvo compared to 4.4% placebo) and jaundice (7.2% Abrysvo compared to 6.7% placebo)

Syncope (fainting)

Fainting may occur following the administration of vaccines. Procedures should be in place to avoid injury from fainting.

Immunosuppression

People who are immunocompromised, including those receiving immunosuppressive therapy, may have a diminished immune response to vaccines.

Limitations

Vaccination may not protect all vaccine recipients.

Children

Abrysvo is not approved for children.

How is Abrysvo administered?

Abrysvo is given by intramuscular injection, usually into the deltoid muscle of the upper arm.

The dose is 0.5mL.

Detailed Abrysvo dosage information

Storage

Before reconstitution, Abrysvo should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Discard if the carton has been frozen.

Abrysvo should be administered immediately after reconstitution or stored for up to 4 hours at room temperature (15°C to 30°C [59°F to 86°F]). Discard reconstituted vaccine that has not been used within 4 hours.

What are the ingredients in Abrysvo?

Abrysvo is a bivalent recombinant stabilized prefusion F protein subunit vaccine (RSVpreF) that contains equal amounts of stabilized prefusion (preF) antigens from the two major RSV subgroups: RSV A and RSV B.

It is supplied as a kit that contains a vial of Lyophilized Antigen Component (a sterile white powder), a prefilled syringe containing the sterile water diluent component, and a vial adapter.

After reconstitution, each dose of Abrysvo is approximately 0.5 mL and contains:

Abrysvo contains no preservatives and residual amounts of host cell proteins (≤0.1% w/w) and DNA (<0.4 ng/mg of total protein) may be present from the manufacturing process.

The vial stopper, tip cap, and rubber plunger of the prefilled syringe are not made with natural rubber latex.

Manufacturer

Pfizer.

Popular FAQ

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). 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

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

  1. FDA Abrysvo prescribing data
  2. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer