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There are two RSV vaccines approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. The CDC recommends that all persons 60 years of age and older consider receiving a single dose of RSV vaccine if they believe that the benefits of the vaccine outweigh the risks.
Pfizer’s ABRYSVO RSV vaccine is FDA approved for use in adults 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV. It is also approved for use in pregnant women for the prevention of RSV illness in their infants. The CDC recommends that all pregnant women between 32- and 36-weeks’ gestation receive a dose of RSV vaccine during the season when RSV is actively circulating.
ABRYSVO is a non-adjuvanted bivalent stabilized prefusion F subunit vaccine that contains 60 mcg each of lyophilized recombinant prefusion F protein from RSV-A and RSV-B subgroups expressed in CHO cells.
Each dose 0.5ml dose also contains 0.11 mg tromethamine, 1.04 mg tromethamine hydrochloride, 22.5 mg mannitol, 11.3 mg sucrose, 0.08 mg polysorbate 80, and 1.1 mg sodium chloride.
ABRYSVO is approved by the FDA to be given as a single dose administered intramuscularly (IM).
GlaxoSmithKline’s AREXVY RSV vaccine is FDA approved for use in adults 60 years and older for the prevention of lower respiratory tract disease caused by RSV. AREXVY is a recombinant stabilized prefusion trimeric F (preF3) protein subunit vaccine. Each 0.5 ml dose contains 120mcg of RSV RSVPreF3 recombinant antigen derived from the RSV fusion surface glycoprotein of an RSV-A strain.
The vaccine also contains the AS01e adjuvant, which is made up from both QS-21 Stimulon and MPL (monophosphyoryl lipid a). QS-21 Stimulon is a purified extract from the bark of the Quillaja saponaria vergreen, or soap bark tree. It is designed to enhance the “turbocharge vaccines by strengthening and broadening immune responses (both T cell and antibody mediated) to a vaccine’s antigens.” MPL is an immune-stimulating fat. After the vaccine is reconstituted, each 0.5 mL dose contains 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of QS-21 and 25 mcg of MPL. Each dose also contains 4.4 mg of sodium chloride, 0.15 mg of disodium phosphate anhydrous, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 14.7 mg of Trehalose, 0.18 mg of polysorbate 80, 0.5 mg of DOPC, and 0.125 mg of cholesterol. Each dose of the vaccine may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process.
AREXVY is approved by the FDA to be given as a single dose administered intramuscularly (IM).
On July 17, 2023 the FDA approved the drug nirsevimab under the trade name Beyfortus, a monoclonal antibody, for the prevention of RSV. Though the CDC has determined that it can define nirsevimab as a vaccine for their purposes, nirsevimab is not classified as a vaccine by the FDA, American Medical Association, or the World Health Organization. To learn about nirsevimab, visit NVIC’s RSV Prevention and Treatment page.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Respiratory Syncytial Virus (RSV) and the Respiratory Syncytial Virus (RSV) vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.