Dear USET/USET SPF Family,
This alert is being shared to provide timely information regarding immunizations as a preventative measure prior to the anticipated seasonal increase of respiratory viruses.
Recently, the United States’ Food and Drug Administration (FDA) has approved two medications to protect babies against severe illness caused by respiratory syncytial virus (RSV) in newborns and infants. Immunizations approved include RSVpreF vaccine for pregnant women or people and nirsevimab for infants.
RSV is usually seen in the late fall and winter, peaking in January and February. Most children contract an RSV infection before two years of age and experience mild symptoms such as runny nose, coughing, sneezing, fever, and occasionally wheezing. In children under 1 years old, RSV symptoms can also include moderate symptoms such as irritability, decreased activity, and apnea (a pause in breathing). In some young children and/or those with underlying health issues (e.g., born prematurely), RSV can progress to severe illness in the form of pneumonia (infection of the lungs) or bronchiolitis (swelling in the small airways in the lungs) and may require hospitalization. RSV is the most common cause of pneumonia and bronchiolitis in children under 1 year of age. Annually, there is an estimated 58,000 to 80,000 hospitalizations of children under 5 years of age and 100 to 300 deaths due to RSV infection.
In addition, due to differences in immune response to the virus and lower socioeconomic conditions, Native American and Alaskan Native (AI/AN) children are at increased risk for severe RSV infections and have had historically high RSV hospitalization rates compared to the general US infant population.
RSVpreF
In August 2023, the FDA approved Pfizer’s bivalent RSVpreF vaccine (trade name Abrysvo) for pregnant people. In clinical trials, this vaccine has been shown to reduce the risk of RSV hospitalization in babies by 57 percent within the first sixth months after birth.
RSVpreF Vaccine Recommendations
On September 22, 2023, the Centers for Disease Control and Prevention (CDC) released a statement recommending the bivalent RSVpreF vaccine to pregnant people to give babies the maximum protection after birth.
- One 120 μg dose intramuscular injection during 32 to 36 weeks’ gestation
- If newborn is born less than two weeks after maternal immunization, it is suggested that the newborn also receive the infant immunization (below)
Nirsevimab
In July 2023, the FDA approved nirsevimab (trade name Beyfortus) for the prevention of RSV in newborns and infants. This immunization has been shown to reduce the risk of hospitalizations due to respiratory syncytial virus (RSV) in infants by up to 80 percent.
Nirsevimab is a monoclonal antibody that aids the body’s immune system to fight off RSV. This is a single injection and provides about 5 months of protection to children in their first or second RSV season. This allows newborns and infants to have protection from RSV infections until they have more mature immune systems and can fight the virus by themselves.
Nirsevimab Immunization Recommendations
On August 3, 2023, the Centers for Disease Control and Prevention (CDC) released a statement recommending the new immunization to protect infants from the RSV season. Dosing recommendations of nirsevimab are:
- One dose for all infants under 8 months of age born during or entering their first RSV season (October through March)
- One dose for children 8 months to 19 months old who are at increased risk of severe RSV disease, including those who are immunocompromised and/or AI/AN.
USET TEC strongly supports the CDC’s recommendations that pregnant people receive one dose of the RSVpreF vaccine, and children under 8 months up to 19 months entering their first or second RSV season receive nirsevimab.
Please consult your medical provider if you are pregnant and/or believe your child would benefit from these medications. For additional information or for clinical guidance, please see the resources below. The USET TEC is available to assist with any questions or concerns. Please do not hesitate to contact us at usetepi@usetinc.org.
Sources
FDA Approves New Drug to Prevent RSV
CDC Recommends New Tool to Protect Infants
CDC Recommends new Vaccine to Help Protect Babies
FDA Approves First Vaccine for Pregnant Individuals
CDC: Health Advisory for RSV
CDC: RSV in Infants and Young Children
CDC: RSV Symptoms and Care
CDC: RSV Prevention
CDC: RSV for Healthcare Providers
Sanofi: Beyfortus Press Release
Beyfortus Prescribing Information
Scientific Articles
RSV Among American Indian and Alaska Native Children: 2019 to 2020
Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants
Safety and Efficacy of Bivalent RSV Prefusion F Vaccine in Vaccinated Mothers and their Infants
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