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Respiratory Syncytial Virus (RSV) and RSV Vaccine Quick Facts
Respiratory Syncytial Virus (RSV)
- Respiratory Syncytial Virus (RSV) is a common respiratory virus with symptoms similar to a mild cold, such as coughing, sneezing, wheezing, decreased appetite, fever, and malaise. The virus is contagious and is transmitted through coughing and sneezing, by coming into direct contact with the virus, and by touching surfaces that contain the virus and then touching your face.
- Young infants, children, older adults, and individuals with immune disorders and underlying chronic health diseases are more at risk of developing RSV infection and suffering from complications of the illness. By two years of age, most infants and children will have had RSV, however, it is possible to have more than one infection during an individual’s lifetime.
- Most individuals who develop an RSV infection will recover fully within one to two weeks without treatment. There are no specific treatments for RSV infection and symptoms can be treated with over-the-counter pain and fever medication, rest, and adequate hydration. Two monoclonal antibodies, Beyfortus (nirsevimab-alip) and Synergis (palivizumab) , have been approved for use by the FDA for the prevention of RSV illness in infants and young children up to two years of age. These drugs, however, are not approved for the treatment of RSV infection.
- Individuals, especially young infants with small airways, may develop complications such as inflammation of the small airways in the lungs (bronchiolitis) or lung infection (pneumonia). Hospitalization may be required for individuals who have breathing problems, or who become dehydrated. Most people who require hospitalization will be discharged within a few days. Infants born prematurely, babies younger than six months of age, and young children with congenital heart and lung disorders, neuromuscular disorders, and those who are immunocompromised are at high risk of developing RSV infection and suffering complications. It is estimated that between four and five million children become infected with RSV in the U.S. each year, with an estimated 58,000 to 80,000 resulting in hospitalization.
- Adults with chronic health diseases, older adults, and those with immune disorders are also at risk of developing RSV illness and suffering complications from infection. The CDC estimates that between 60,000 and 120,000 older adults develop RSV infections that require hospitalization, with 6,000 to 10,000 of those contributing to death.
Respiratory Syncytial Virus (RSV) Vaccine
- There are two RSV vaccines licensed for use in the US: ABRYSVO, a bivalent unadjuvanted prefusion F subunit vaccine manufactured by Pfizer; and AREXVY, a recombinant stabilized prefusion trimeric F (preF3) protein subunit vaccine, containing the AS01e adjuvant. ABRYSVO is licensed for use in adults 60 years of age and older and in pregnant women, for the prevention of RSV illness in their infants while AREXVY is licensed for use in adults 60 years of age and older. The CDC’s use recommendation is for individuals 60 years of age and older to consider receiving a dose of the vaccine if they believe that the potential benefits from the vaccine outweigh the risks. RSV vaccines are also recommended for pregnant women, between 32- and 36-weeks’ gestation during the season when RSV is actively circulating.
- Vaccine complications in vaccine recipients for both vaccines reported during clinical trials was a higher rate of Guillain-Barre Syndrome (GBS), a serious neurological disorder, and atrial fibrillation, a serious heart disorder, that may lead to complications such as stroke, heart attack, or heart failure. Clinical trial data also showed that when AREXVY was given at the same time as the quadrivalent influenza vaccine there was a significantly increased risk of Acute Disseminated Encephalomyelitis (ADEM), a serious and potentially fatal swelling of the brain and spinal cord.
- ABRYSVO clinical trial data for vaccinated pregnant women reported higher rates of preterm deliveries, pre-eclampsia, swelling of the hands and feet, protein in the urine, and gestational hypertension) than those who received the placebo.
- As of January 26, 2024, there have been 3,425 reports of RSV vaccine reactions, including 22 deaths and 199 hospitalizations. Over 83 percent of adverse events occurred in persons 60 years of age and older.
Food & Drug Administration (FDA)
- AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Package Insert and Licensing Information
- ABRYSVO (Respiratory Syncytial Virus Vaccine) Package Insert and Licensing Information
- Beyfortus (nirsevimab-alip) Package Insert and Prescribing Information
- SYNAGIS® (palivizumab) Package Insert and Prescribing Information
Centers for Disease Control (CDC)
- Respiratory Syncytial Virus (RSV)
- Respiratory Syncytial Virus (RSV) Vaccine Information Statement (VIS)
Vaccine Reaction Symptoms & Ingredients
NVIC’s Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms.
Search for Vaccine Reactions
NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.
Reporting a Vaccine Reaction
Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is required by federal law under the National Childhood Vaccine Injury Act of 1986. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.
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.