- The CDC has issued new guidance for an RSV drug that can help protect infants.
- There has been an ongoing shortage of the drug, which is a monoclonal antibody treatment.
- In August, the FDA approved an RSV vaccine for use in pregnant people to help protect newborns from the highly contagious disease.
The new guidelines recommend that pediatricians prioritize giving the drug Beyfortus (nirsevimab) to infants at the highest risk of developing severe symptoms if they contract RSV.
Beyfortus is not a vaccine but a monoclonal antibody shot that can be given to infants before they get sick.
According to the CDC, 100-milligram doses should be given to infants over 11 pounds at the highest risk of severe disease. The recommendations for the 50 mg shots, which are generally for children under 11 pounds, remain unchanged.
However, the monoclonal antibody shot is not the only way to protect infants against RSV.
The Food and Drug Administration (FDA)
We talked to experts about what parents should know about the virus and how they can protect their kids.
Earlier this summer, the American Academy of Pediatrics (AAP) advised that all infants should receive the monoclonal antibody treatment Beyfortus. According to the AAP, a single dose of Beyfortus is recommended for:
- All infants younger than 8 months during or entering their first RSV season.
- Infants and children ages 8 to 19 months at increased risk of severe RSV disease and entering their second RSV season.
The AAP outlines that Beyfortus is an intramuscular injection with a prefilled syringe. It is given as a single dose to infants at 50 milligrams for children weighing less than 11 pounds and 100 milligrams for children weighing 11 pounds and above.
Side effects of Beyfortus include rash and injection site reactions.
Beyfortus will be covered by insurance and through the Vaccines for Children (VFC) program, which covers immunizations for Medicaid-eligible, uninsured, or underinsured children.
The AAP says the monoclonal antibody shot is expected to cost $495 in the private sector and $395 in the VFC program. It is unclear if the shot will be included in bundled payments for newborn care.
“There does not seem to be clear information as of yet regarding how nirsevimab [Beyfortus] will be distributed or how private insurers will handle it,” said Dr. Rebecca Fisk, a pediatrician at Northwell Lenox Hill Hospital in New York.
“VC inclusion means that those children who are eligible will get this through federal funds. Still, there are many unanswered questions regarding how parents will obtain this monoclonal antibody for their infants at a time when RSV season is just around the corner. More information is needed from private and public insurers regarding cost and insurance coverage.”
Respiratory syncytial virus, commonly known as RSV, is a respiratory infection that causes cold-like symptoms in healthy adults but can be particularly dangerous for young infants and older adults, leading to lower respiratory tract disease that can sometimes be severe.
The Beyfortus shot is an effective method for helping to keep infants safe. Efficacy was about 81% against hospitalization, according to the
“Children under age 6 months, premature infants that require intensive care in the first few weeks or months of life, and children with underlying heart or lung conditions are at extremely high risk to suffer from severe disease,” said Dr. Sara Siddiqui, a pediatrician with NYU Langone Huntington Medical Group.
“RSV is known to cause respiratory symptoms and difficulty breathing in young infants leading to hospitalization and possibly death.”
Siddiqui told Healthline she will be discussing RSV risk with her patients in the coming months.
“I will include conversations about specific risks and benefits for patients and how best to protect their infant from RSV and other viruses. The RSV protection will be one of the tools we can now recommend to help to reduce hospitalizations in our children,” Siddiqui said.
The new RSV vaccine is given to pregnant people later in their pregnancy in the hopes that newborns will be protected in the first few months of their life.
When a pregnant person gets vaccinated against RSV, they can pass on key antibodies to children after they are born. For the first few months of a child’s life, these antibodies from their parent can help protect them against disease.
“RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” said
“This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
While there are currently no medications to treat RSV, there are ways to help prevent it.
Both the Abrysvo vaccine for pregnant people and the Beyfortus monoclonal antibody shot for infants are ways to help keep everyone healthy and safe.
What is the difference between the RSV monoclonal antibody shot and the vaccine?
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off viruses almost immediately.
Vaccines are meant for long-term protection and prevention.
“Nirsevimab [Beyfortus] is a monoclonal antibody, not a vaccine, given in a single intramuscular shot, which studies have shown provides protection which lasts for 150 days or about five months,” Fisk said.
A clinical study evaluated the effectiveness of Abrysvo, the vaccine, to lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants born to vaccinated individuals during pregnancy.
The study found that Abrysvo reduced the risk of severe lower respiratory tract disease by 82% within 90 days after birth and 69% within 180 days after birth.
The CDC issued new guidance for pediatricians about the monoclonal antibody shot for infants to protect against RSV.
While the RSV vaccine Abrysvo is not yet available for infants, the FDA approved the shot for pregnant people to help protect their newborns against the highly contagious virus.